510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINALDECISIONS RENDERED DURING THE PERIOD September 2014DEVICE: DA VINVI SURGICAL SYSTEMINTUITIVE SURGICAL, INC. 510(k) NO: K123329(Traditional)ATTN: CINDYDOMECUSPHONE NO : 650 343-4813 1450 Kifer Rd --SE DECISION MADE: 17-SEP-14Sunnyvale CA94086510(k) SUMMARY AVAILABLE FROM FDADEVICE: IROOT FMINNOVATIVE BIOCERAMIX INC.510(k) NO: K130312(Traditional)ATTN: QUANZUYANG PHONE NO : 604 221 6800 1628 WEST 75TH AVE.SE DECISION MADE: 18-SEP-14VANCOUVER, BCCA V6P 6G2510(k) SUMMARY AVAILABLE FROM FDADEVICE: SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVEPURNA BINA SDN BHD 510(k) NO: K130450(Traditional)ATTN: ROBERTHILL PHONE NO : 607 787 9128 PLO 5, JALAN MAHSURI, 7.5KM, JALANSE DECISION MADE: 30-SEP-14KLUANG, JOHORMY 86000510(k) STATEMENTDEVICE: POWEDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)DAHOON PLASTIC CO., LTD. 510(k) NO: K130742(Traditional)ATTN: CHUXIAOANPHONE NO : 861 082 387441 ROOM 1606 BLDG. 1 JIANXIANG YUAN NSE DECISION MADE: 10-SEP-14BEIJINGCN 100083 510(k) SUMMARY AVAILABLE FROM FDADEVICE: FIA Blood Glucose Monitoring System (G2)HMD BIOMEDICAL, INC.510(k) NO: K131173(Traditional)ATTN: AXELLIN PHONE NO : 886 360 17000 #181 MINSHENG STREETSE DECISION MADE: 18-SEP-14XINPU TOWNSHIP, HSINCHU COUNTYTW510(k) SUMMARY AVAILABLE FROM FDADEVICE: POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVESMADE PLASTIC CO., LTD.510(k) NO: K131340(Traditional)ATTN: CHUXIAOANPHONE NO : 861 082 387441 RM 1606 BLDG. 1. JIANXIANG YUAN NOSE DECISION MADE: 09-SEP-14BEIJINGCN 100083 510(k) SUMMARY AVAILABLE FROM FDADEVICE: EXTRACORPOREAL SHOCK WAVE LITHOTRIPTEROSMUNDA MEDICAL DEVICE CONSULTING 510(k) NO: K131817(Traditional)ATTN: MIKEGUPHONE NO : 008 62 062321333 NO. 982 COGYUN ROAD BAIYUN DISTRICSE DECISION MADE: 26-SEP-14GUANGZHOU, GUANGDONGCN 510420510(k) SUMMARY AVAILABLE FROM FDADEVICE: LONGFIAN OXYGEN CONCENTRATORLONGFIAN SCITECH CO., LTD.510(k) NO: K131968(Traditional)ATTN: JUNPENG PHONE NO : 305 609-4701 6840 SW 45TH LN UNIT 5SE DECISION MADE: 05-SEP-14MIAMI FL33155 510(k) SUMMARY AVAILABLE FROM FDADEVICE: ITRAC CERVICAL TRACTION SYSTEMPIVOTAL HEALTH SOLUTIONS 510(k) NO: K131983(Traditional)ATTN: AARONTVEDT PHONE NO : 605 753-0110 724 OAKWOOD RDSE DECISION MADE: 10-SEP-14WATERTOWN SD57201510(k) SUMMARY AVAILABLE FROM FDADEVICE: STATSTRIP GLUCOSE HOSPITAL METER SYSTEMNOVA BIOMEDICAL CORPORATION 510(k) NO: K132121(Traditional)ATTN: PAUL W MACDONALD, PHD PHONE NO : 781 647-3700 200 Prospect St SE DECISION MADE: 24-SEP-14WALTHAM MA02454510(k) SUMMARY AVAILABLE FROM FDADEVICE: AJAX DENTAL UNITPRO DENTAL SERVICES LLC. 510(k) NO: K132245(Traditional)ATTN: JOHNNEACSU PHONE NO : 703 206-8570 1121 PLAYER WAY SE DECISION MADE: 05-SEP-14HERNDON VA20170510(k) SUMMARY AVAILABLE FROM FDADEVICE: ONE PLUS IMPLANT SYSTEMOSSEOFUSE, INC. 510(k) NO: K133050(Traditional)ATTN: PriscillaChungPHONE NO : 714 202-5789 2651 E CHAPMAN AVE STE 110SE DECISION MADE: 19-SEP-14FULLERTON CA92833510(k) SUMMARY AVAILABLE FROM FDADEVICE: XENMATRIX AB SURGICAL GRAFTC.R. BARD, INC. 510(k) NO: K133223(Traditional)ATTN: TonyJohnPHONE NO : 401 825-8692 100 CROSSINGS BLVD.SE DECISION MADE: 19-SEP-14WARWICK RI02886510(k) SUMMARY AVAILABLE FROM FDADEVICE: ENDO SMARTMETA BIOMED, INC.510(k) NO: K133298(Traditional)ATTN: BLIXWINSTONPHONE NO : 301 607-9185 2600 MULLINIX MILL ROADSE DECISION MADE: 19-SEP-14MT. AIRY MD21771 510(k) SUMMARY AVAILABLE FROM FDADEVICE: SURESUBTRACTION LUNGTOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K133324(Traditional)ATTN: PAULBIGGINSPHONE NO : 714 730-5000 2241 MICHELLE DRSE DECISION MADE: 05-SEP-14TUSTIN CA92780510(k) SUMMARY AVAILABLE FROM FDADEVICE: POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETERC.R. BARD, INC. 510(k) NO: K133456(Traditional)ATTN: AMYHONEYPHONE NO : 801 522-6571 605 N 5600 W SE DECISION MADE: 24-SEP-14SALT LAKE CITY UT84116 510(k) SUMMARY AVAILABLE FROM FDADEVICE: CLYDESDALE(R) SPINAL SYSTEMMedtronic 510(k) NO: K133577(Traditional)ATTN: LEEGRANTPHONE NO : 901 344-0807 1800 PYRAMID PLACE SE DECISION MADE: 26-SEP-14MEMPHIS TN38132510(k) SUMMARY AVAILABLE FROM FDADEVICE: IN TOUCH BLOOD GLUCOSE MONITORING SYSTEMEOSHEALTH, INC. 510(k) NO: K133584(Traditional)ATTN: CarrieHetrick PHONE NO : 512 327-9997 816 CONGRESS AVE, STE 1400SE DECISION MADE: 08-SEP-14AUSTIN TX78701510(k) SUMMARY AVAILABLE FROM FDADEVICE: PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATIONPHILIPS MEDICAL SYSTEMS510(k) NO: K133603(Traditional)ATTN: SUSANQUICK PHONE NO : 440 483-2291 595 MINER ROADSE DECISION MADE: 25-SEP-14CLEVELAND OH44143510(k) SUMMARY AVAILABLE FROM FDADEVICE: LONGBOW SPACER SYSTEMLIFE SPINE510(k) NO: K133717(Traditional)ATTN: RANDYLEWIS PHONE NO : 847 884-6117 2401 Hassell Rd Ste 1535 SE DECISION MADE: 19-SEP-14Hoffman Est IL60169 510(k) SUMMARY AVAILABLE FROM FDADEVICE: TRUSCULPTCUTERA, INC. 510(k) NO: K133739(Traditional)ATTN: BRADLEYRENTON PHONE NO : 415 657-5568 3240 BAYSHORE BLVD SE DECISION MADE: 05-SEP-14BRISBANE CA94005 510(k) SUMMARY AVAILABLE FROM FDADEVICE: MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTORINFOBIONIC, INC.510(k) NO: K133753(Traditional)ATTN: CARRIENEUBERGERPHONE NO : 415 640-3377 600 SUFFOLK STREET P.O. BOX 9719SE DECISION MADE: 19-SEP-14LOWELL MA01853510(k) SUMMARY AVAILABLE FROM FDADEVICE: QMASTER-H/REVOTELESYSTEMS CO., LTD. 510(k) NO: K133797(Traditional)ATTN: ClaudeBerthoinPHONE NO : 386 672-0450 110 EAST GRANADA BLVD.SE DECISION MADE: 04-SEP-14ORMOND BEACH FL32176510(k) SUMMARY AVAILABLE FROM FDADEVICE: ALERE PBP2A SA/CONS CULTURE COLONY TESTALERE SCARBOROUGH, INC510(k) NO: K133851(Traditional)ATTN: DANIELLE A BRIGGEMANPHONE NO : 207 730-5750 10 Southgate RoadSE DECISION MADE: 03-SEP-14Scarborough ME04074 510(k) SUMMARY AVAILABLE FROM FDADEVICE: APOLLO BALLOON DILATATION CATHETERBROSMED MEDICAL 510(k) NO: K133852(Traditional)ATTN: STEPHENLEE PHONE NO : 86 769 22892018 15TH-BUILDING,SMES VENTURE PARK,SOSE DECISION MADE: 19-SEP-14DONGGUANCN 523808510(k) SUMMARY AVAILABLE FROM FDADEVICE: PREMIUMCOUSIN BIOTECH S.A.S. 510(k) NO: K133889(Traditional)ATTN: FRANCKPELLETIERPHONE NO : 333 20 144000 8 RUE DE L ABBE BONPAIN ALLEE DES SE DECISION MADE: 04-SEP-14WERVICQ-SUDFR 59117 510(k) SUMMARY AVAILABLE FROM FDADEVICE: DEKA SMARTXIDE LASER SYSTEMEL.EN. S.P.A 510(k) NO: K133895(Traditional)ATTN: GEORGECHOPHONE NO : 508 435-9140 2 JORDAN ROADSE DECISION MADE: 05-SEP-14HOPKINTON MA01748510(k) SUMMARY AVAILABLE FROM FDADEVICE: GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEMGENESYS SPINE510(k) NO: K133911(Traditional)ATTN: BRIAN J BERGERONPHONE NO : 512 381-7071 1250 CAPITAL OF TEXAS HWY SOUTH BUSE DECISION MADE: 03-SEP-14AUSTIN TX78746510(k) SUMMARY AVAILABLE FROM FDADEVICE: SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVEAdhezion Biomedical, LLC 510(k) NO: K133963(Special)ATTN: CaridadSmithPHONE NO : 828 572-4201 ONE MERIDIAN BLVD. SUITE 1B02SE DECISION MADE: 09-SEP-14WYOMISSING PA19610510(k) SUMMARY AVAILABLE FROM FDADEVICE: FUJIFILM ENDOSCOPIC CO2 REGULATORFUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K133976(Traditional)ATTN: GINAWALLJASPERPHONE NO : 973 686-2636 10 HIGH POINT DRIVESE DECISION MADE: 09-SEP-14WAYNE NJ07470 510(k) SUMMARY AVAILABLE FROM FDADEVICE: INTRA. OX HANDHELD TISSUE OXIMETERVIOPTIX INC. 510(k) NO: K133983(Traditional)ATTN: GREGHOLLANDPHONE NO : 949 262-0411 3722 AVE. SAUSALITOSE DECISION MADE: 12-SEP-14IRVINE CA92606510(k) SUMMARY AVAILABLE FROM FDADEVICE: RHINIX NASAL FILTERRHINIX APS510(k) NO: K134003(Traditional)ATTN: METTEMUNCH PHONE NO : 452 987 2000 SKAGENVEJ 21 SE DECISION MADE: 04-SEP-14EGAADK DK-8200510(k) SUMMARY AVAILABLE FROM FDADEVICE: GENERAL SPINAL SYSTEMCHANGZHOU DEAN MEDICAL INSTRUMENT 510(k) NO: K134011(Traditional)ATTN: DianaHongPHONE NO : 86 21 22815850 P.O. BOX 120-119SE DECISION MADE: 03-SEP-14SHANGHAICN 200120510(k) SUMMARY AVAILABLE FROM FDADEVICE: MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTONXSTAGE MEDICAL, INC. 510(k) NO: K134019(Traditional)ATTN: LAURA F PLATHPHONE NO : 978 332-5973 350 MERRIMACK STREETSE DECISION MADE: 11-SEP-14LAWRENCE MA01843 510(k) SUMMARY AVAILABLE FROM FDADEVICE: AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CTTOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K134025(Traditional)ATTN: PAULBIGGINSPHONE NO : 714 669-7808 2441 MICHELLE DRIVESE DECISION MADE: 05-SEP-14TUSTIN CA92780510(k) SUMMARY AVAILABLE FROM FDADEVICE: TRANSONIC HCM 103 SYSTEMTRANSONIC SYSTEMS, INC.510(k) NO: K134035(Traditional)ATTN: NAVEENTHURAMALLA PHONE NO : 607 257-7256 34 Dutch Mill RdSE DECISION MADE: 17-SEP-14ITHACA NY14850510(k) SUMMARY AVAILABLE FROM FDADEVICE: BTL-9000; BTL-9000 RADIOFREQUENCY MODULEBTL INDUSTRIES LTD 510(k) NO: K134040(Traditional)ATTN: MICHAIL M PANKRATOVPHONE NO : 617 480-4543 16 APPLETON STREET SE DECISION MADE: 10-SEP-14WALTHAM MA02453510(k) SUMMARY AVAILABLE FROM FDADEVICE: SOPIX INSIDE, SOPIX2 INSIDESOPRO - ACTEON GROUP510(k) NO: K140013(Traditional)ATTN: RICKROSATI PHONE NO : 800 289-6367 124 GAITHER DRIVE SUITE #140SE DECISION MADE: 05-SEP-14MT. LAUREL NJ08055510(k) STATEMENTDEVICE: TRANSONIC HCM 102 SYSTEMTRANSONIC SYSTEMS, INC.510(k) NO: K140017(Traditional)ATTN: NAVEENTHURAMALLA PHONE NO : 607 257-5300 34 Dutch Mill RdSE DECISION MADE: 16-SEP-14ITHACA NY14850510(k) SUMMARY AVAILABLE FROM FDADEVICE: POLYCRYLAUROLAB510(k) NO: K140039(Traditional)ATTN: KRISHNAKUMAR.RPHONE NO : 91 45230 96100 NO 1, SIVAGANGAI MAIN ROAD VEERAPASE DECISION MADE: 15-SEP-14MADURAI, TAMILNADUIN 625020510(k) STATEMENTDEVICE: NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUEHARTALEGA SDN BHD510(k) NO: K140050(Traditional)ATTN: NURULAISHYAH KONGPHONE NO : 603 328 03888 NO. 7, KAWASAN PERUSAHAAN SURIASE DECISION MADE: 12-SEP-14BESTARI JAYAMY 45600510(k) STATEMENTDEVICE: ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTEDALBAAD LTD.510(k) NO: K140077(Traditional)ATTN: ROBERT J STAAB, PH.D. PHONE NO : 860 434-5872 30 NECK ROAD SE DECISION MADE: 22-SEP-14OLD LYME CT06371 510(k) SUMMARY AVAILABLE FROM FDADEVICE: PHANTOM XL INSULATED DILATORSTEDAN SURGICAL INNOVATIONS, LLC510(k) NO: K140088(Traditional)ATTN: JOANN(DIONICIA)REBLANDOPHONE NO : 858 472-5160 12615 W AIRPORT BLVD, SUITE 200SE DECISION MADE: 25-SEP-14SUGAR LAND TX77478510(k) SUMMARY AVAILABLE FROM FDADEVICE: AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEMAPPLIED MEDICAL TECHNOLOGY, INC.510(k) NO: K140097(Traditional)ATTN: JOSHUAMEINKEPHONE NO : 440 7174000 8000 KATHERINE BOULEVARD SE DECISION MADE: 24-SEP-14BRECKSVILLE OH44141 510(k) STATEMENTDEVICE: RENAISSANCE X SYSTEMMAZOR ROBOTICS LTD 510(k) NO: K140167(Traditional)ATTN: AHAVASTEIN PHONE NO : 972 976 70002 20 HATA'AS ST. (POB 124) SE DECISION MADE: 10-SEP-14KFAR SABAIL 44425510(k) SUMMARY AVAILABLE FROM FDADEVICE: SURGICAL DRAPEGRIFFITH-LUCAS LLC 510(k) NO: K140195(Traditional)ATTN: MIKEGUPHONE NO : 86 20 62321333 7TH FLOOR, JINGUI BUSINESS BUILDINSE DECISION MADE: 10-SEP-14GUANGZHOU, GUANGDONGCN 510420510(k) SUMMARY AVAILABLE FROM FDADEVICE: FORTICORENANOVIS, LLC 510(k) NO: K140280(Traditional)ATTN: KAREN E WARDEN PHD PHONE NO : 440 729-8457 PO BOX 566SE DECISION MADE: 05-SEP-14CHESTERLAND OH44026 510(k) SUMMARY AVAILABLE FROM FDADEVICE: STARBRIGHT 5% SODIUM FLUORIDE VARNISHNANOVA BIOMATERIALS, INC.510(k) NO: K140349(Traditional)ATTN: ANDREWRITTSPHONE NO : 573 875-6682 3806 MOJAVE CTSE DECISION MADE: 22-SEP-14COLUMBIA MO65202 510(k) SUMMARY AVAILABLE FROM FDADEVICE: KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBESKATALYST SURGICAL, LLC510(k) NO: K140362(Traditional)ATTN: MONADEANPHONE NO : 636 536-5950 754 Goddard ave SE DECISION MADE: 15-SEP-14Chesterfield MO63005510(k) SUMMARY AVAILABLE FROM FDADEVICE: ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIXHARBOR MEDTECH, INC.510(k) NO: K140367(Traditional)ATTN: JERRYMEZGERPHONE NO : 949 679-4800 4 JENNER SUITE 190 SE DECISION MADE: 12-SEP-14IRVINE CA92618510(k) SUMMARY AVAILABLE FROM FDADEVICE: MEDLINE NEURO SPONGEMEDLINE INDUSTRIES, INC. 510(k) NO: K140369(Traditional)ATTN: MATTCLAUSENPHONE NO : 847 643-4785 ONE MEDLINE PLACESE DECISION MADE: 26-SEP-14MUNDELEIN IL60006510(k) STATEMENTDEVICE: FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT)ABBOTT DIABETES CARE INC.510(k) NO: K140371(Traditional)ATTN: MICHELLERICAFORT PHONE NO : 510 749-5250 1360 SOUTH LOOP ROADSE DECISION MADE: 30-SEP-14ALAMEDA CA94502510(k) SUMMARY AVAILABLE FROM FDADEVICE: XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K140377(Traditional)ATTN: TinaIpPHONE NO : 416 593 4323 439 UNIVERSITY AVE.SE DECISION MADE: 16-SEP-14TORONTO, ONTARIOCA M5G 1Y8510(k) SUMMARY AVAILABLE FROM FDADEVICE: FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUITOMNIGUIDE, INC. 510(k) NO: K140378(Traditional)ATTN: NICOLERASMUSSENPHONE NO : 617 551-8556 ONE KENDALL SQUARE SUITE B1301 SE DECISION MADE: 25-SEP-14CAMBRIDGE MA02139510(k) SUMMARY AVAILABLE FROM FDADEVICE: OPERA SWINGGENERAL MEDICAL MERATE S.P.A.510(k) NO: K140380(Traditional)ATTN: BERTHOINCLAUDEPHONE NO : 877 509-3180 110 E. GRANADA BLVD SUITE 209SE DECISION MADE: 26-SEP-14ORMOND BEACH FL32176510(k) STATEMENTDEVICE: TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESISBIOMET MANUFACTURING CORP.510(k) NO: K140390(Traditional)ATTN: BRIANKINCAIDPHONE NO : 574 372-3992 56 EAST BELL DRIVE P.O. BOX 587SE DECISION MADE: 10-SEP-14WARSAW IN46581-0587 510(k) SUMMARY AVAILABLE FROM FDADEVICE: EBM IDO VIEWEREBM TECHNOLOGIES USA, LLC510(k) NO: K140399(Traditional)ATTN: JOHNSUPHONE NO : 808 945-3100 641 Keeaumoku St Ste 5SE DECISION MADE: 18-SEP-14Honolulu HI96814 510(k) STATEMENTDEVICE: TREKKER, TREKKER TRANSITCONVAID PRODUCTS, INC.510(k) NO: K140416(Traditional)ATTN: DONALDGRIGGSPHONE NO : 310 618-0111 2830 CALIFORNIA ST.SE DECISION MADE: 17-SEP-14TORRANCE CA90503 510(k) SUMMARY AVAILABLE FROM FDADEVICE: POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILEWRP RUBBER PRODUCTS SDN BHD 510(k) NO: K140418(Traditional)ATTN: LIM CHINYITPHONE NO : 60 16695 7817 LOT 3, JALAN 3, KAWASAN PERUSAHAANSE DECISION MADE: 03-SEP-14SEPANG ,SELANGOR DARUL EHSANMY 4510(k) SUMMARY AVAILABLE FROM FDADEVICE: CRANE ACRYLIC HERBST APPLIANCECRANE DENTAL LABORATORY, INC.510(k) NO: K140429(Traditional)ATTN: KATEYOUNGPHONE NO : 585 730-5100 200 AIRPARK DRIVE, SUITE 30 SE DECISION MADE: 11-SEP-14ROCHESTER NY14624510(k) SUMMARY AVAILABLE FROM FDADEVICE: CONTACT LENS CASEMACA PLASTICS, INC.510(k) NO: K140488(Traditional)ATTN: CORRINACULBERTSONPHONE NO : 937 544-8618 3455 CROSS ROAD SE DECISION MADE: 10-SEP-14WINCHESTER OH45697510(k) SUMMARY AVAILABLE FROM FDADEVICE: Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System ReagentsBECKMAN COULTER, INC. 510(k) NO: K140496(Special)ATTN: NANETTECANEPA PHONE NO : 714 961-3136 250 S. KRAEMER BLVD. MAIL STOP E1.SE DECISION MADE: 16-SEP-14BREA CA92821510(k) SUMMARY AVAILABLE FROM FDADEVICE: TRUE BEAM, TRUE BEAM STX, EDGEVARIAN MEDICALSYSTEMS, INC.510(k) NO: K140528(Traditional)ATTN: PETER J CORONADOPHONE NO : 650 424-6320 3100 HANSEN WAY SE DECISION MADE: 05-SEP-14PALO ALTO CA94304510(k) SUMMARY AVAILABLE FROM FDADEVICE: CONCHASMART BREATHING CIRCUITTELEFLEX, INC.510(k) NO: K140556(Traditional)ATTN: AmandaWebb PHONE NO : 919 433-8050 2917 WECK DR.SE DECISION MADE: 24-SEP-14RESEARCH TRIANGLE PARK NC27709510(k) SUMMARY AVAILABLE FROM FDADEVICE: MIVI 6F GUIDE CATHETERMIVI, LLC 510(k) NO: K140557(Traditional)ATTN: MICHELLESTRAIGHT PHONE NO : 763 577-9600 10900 73RD AVE NE, SUITE 150SE DECISION MADE: 18-SEP-14MAPLE GROVE MN55369 510(k) SUMMARY AVAILABLE FROM FDADEVICE: MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIREMERIT MEDICAL SYSTEMS, INC. 510(k) NO: K140608(Special)ATTN: SIOBHANKINGPHONE NO : 353 917 03700 PARKMORE BUSINESS PARK WEST SE DECISION MADE: 12-SEP-14GALWAYIE EI510(k) SUMMARY AVAILABLE FROM FDADEVICE: MAGEC SPINAL BRACING AND DISTRACTION SYSTEMELLIPSE TECHNOLOGIES INC.510(k) NO: K140613(Traditional)ATTN: JohnMcIntyrePHONE NO : 949 837-3600 13900 ALTON PKWY STE 123 SE DECISION MADE: 18-SEP-14IRVINE CA92618-0000 510(k) SUMMARY AVAILABLE FROM FDADEVICE: extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing KitDevon Medical, Inc.510(k) NO: K140634(Traditional)ATTN: SteveXU PHONE NO : 866 446-0092 42721100 First Avenue, Suite 202SE DECISION MADE: 19-SEP-14King of Prussia PA19406510(k) SUMMARY AVAILABLE FROM FDADEVICE: ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ELLIPSE A/S510(k) NO: K140670(Traditional)ATTN: OLEKOFODPHONE NO : 45 451 76863 AGERN ALLE 11SE DECISION MADE: 25-SEP-14HOERSHOLMDK DK-2970 510(k) SUMMARY AVAILABLE FROM FDADEVICE: BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZERSHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K140690(Traditional)ATTN: SUSAN D GOLDSTEIN-FALKPHONE NO : 949 706-7456 55 NORTHERN BLVD., SUITE 200SE DECISION MADE: 02-SEP-14GREAT NECK NY11021510(k) SUMMARY AVAILABLE FROM FDADEVICE: BIOMET GRAFT DELIVERY SYRINGESBIOMET SPINE (AKA EBI, LLC) 510(k) NO: K140710(Traditional)ATTN: DEBRA L BING PHONE NO : 973 299-9300 3964399 JEFFERSON ROAD SE DECISION MADE: 04-SEP-14PARSIPPANY NJ07054510(k) SUMMARY AVAILABLE FROM FDADEVICE: PICOSURE WORKSTATIONCYNOSURE, INC.510(k) NO: K140719(Traditional)ATTN: KEVINO'CONNELLPHONE NO : 978 367-8736 5 CALISLE ROADSE DECISION MADE: 22-SEP-14WESTFORD MA01886 510(k) SUMMARY AVAILABLE FROM FDADEVICE: M-PM-DISC (PINK)MERZ DENTAL GMBH510(k) NO: K140758(Traditional)ATTN: RICHARD G HUNTERPHONE NO : 505 400-4992 5616 MARIOLA PL NE SE DECISION MADE: 15-SEP-14ALBUQUERQUE NM87111 510(k) SUMMARY AVAILABLE FROM FDADEVICE: KEGEL SMART, KEGELSMART PEARLREGULATORY INSIGHT, INC. 510(k) NO: K140780(Traditional)ATTN: KevinWalls PHONE NO : 720 962-5412 33 Golden Eagle LaneSE DECISION MADE: 10-SEP-14Littleton CO80127510(k) SUMMARY AVAILABLE FROM FDADEVICE: XENCO MEDICAL CERVICAL INTERBODY SYSTEMXENCO MEDICAL, LLC 510(k) NO: K140786(Traditional)ATTN: GUSTAVO R PRADO PHONE NO : 858 202-1522 9930 MESA RIM DRIVESE DECISION MADE: 03-SEP-14SAN DIEGO CA92121510(k) STATEMENTDEVICE: VDRIVE WITH V-LOOP/ VDRIVE DUOSTEREOTAXIS, INC.510(k) NO: K140804(Traditional)ATTN: DIANEHORWITZ, PH.D., RACPHONE NO : 703 307-2921 2995 STEVEN MARTIN DR,SE DECISION MADE: 03-SEP-14FAIRFAX VA22031510(k) SUMMARY AVAILABLE FROM FDADEVICE: LUCID LYBIO-MED USA INC.510(k) NO: K140837(Traditional)ATTN: YOUNGCHIPHONE NO : 973 278-5222 27 NEW ENGLAND DRIVESE DECISION MADE: 24-SEP-14RAMSEY NJ07446510(k) SUMMARY AVAILABLE FROM FDADEVICE: TABLO CARTRIDGEHOME DIALYSIS PLUS 510(k) NO: K140841(Traditional)ATTN: NANCYGALLO PHONE NO : 510 682-6505 257 HUMBOLDT COURT SE DECISION MADE: 11-SEP-14SUNNYVALE CA94089510(k) SUMMARY AVAILABLE FROM FDADEVICE: INFRARED HEATING DEVICEPRO MEDICAL SUPPLIES, INC.510(k) NO: K140865(Traditional)ATTN: DORISDONGPHONE NO : 862 131 261348 ROOM 1706, NO. 128 SONGLE RD. SONGSE DECISION MADE: 03-SEP-14SHANGHAICN 201600510(k) SUMMARY AVAILABLE FROM FDADEVICE: TABLO CONSOLEHOME DIALYSIS PLUS 510(k) NO: K140866(Traditional)ATTN: NANCYGALLO PHONE NO : 510 682-6505 257 HUMBOLDT COURT SE DECISION MADE: 10-SEP-14SUNNYVALE CA94089510(k) SUMMARY AVAILABLE FROM FDADEVICE: GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFFSHANGHAI GOAHUI RUBBER AND PLASTIC510(k) NO: K140874(Traditional)ATTN: RHONDAALEXANDER, MS, MPAPHONE NO : 757 224-0177 144 RESEARCG DRIVE SE DECISION MADE: 02-SEP-14HAMPTON VA23666510(k) SUMMARY AVAILABLE FROM FDADEVICE: VERICORE ZIRCONIA BLANKSWHIP MIX CORP.510(k) NO: K140877(Traditional)ATTN: JOHNWATERS PHONE NO : 502 634-5357 361 FARMINGTON AVE SE DECISION MADE: 03-SEP-14LOUISVILLE KY40217510(k) SUMMARY AVAILABLE FROM FDADEVICE: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEMBECKMAN COULTER, INC. 510(k) NO: K140911(Abbreviated)ATTN: BRENTLEMBERGPHONE NO : 305 380-4509 11800 SW 147TH AVE.SE DECISION MADE: 05-SEP-14MIAMI FL33196 510(k) SUMMARY AVAILABLE FROM FDADEVICE: SOMATOM SCOPE/SOMATOM SCOPE POWERSIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K140912(Traditional)ATTN: EVEDAVISPHONE NO : 610 219-7133 51 VALLEY STREAM PKWY.SE DECISION MADE: 15-SEP-14MALVERN PA19355-1406510(k) SUMMARY AVAILABLE FROM FDADEVICE: ABPM7100I.E.M. GMBH510(k) NO: K140928(Traditional)ATTN: ARNEBRIEST PHONE NO : 492 402950 00 COCKERILLSTRASSE 69SE DECISION MADE: 15-SEP-14STOLBERGDE D-52222510(k) SUMMARY AVAILABLE FROM FDADEVICE: COMPAT ENTERAL DELIVERY PUMP SETSNESTLE HEALTHCARE NUTRITION, INC. 510(k) NO: K140947(Traditional)ATTN: M.W.(ANDY)ANDERSONPHONE NO : 952 746-8079 5353 WAYZATA BOULEVARD, SUITE 505 SE DECISION MADE: 04-SEP-14MINNEAPOLIS MN55416 510(k) SUMMARY AVAILABLE FROM FDADEVICE: CALCULASE IIKARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K140964(Traditional)ATTN: WINKIEWONG PHONE NO : 424 218-8379 2151 E. GRAND AVE. SE DECISION MADE: 04-SEP-14EL SEGUNDO CA90245-5017510(k) SUMMARY AVAILABLE FROM FDADEVICE: RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDERANFAC CORP. 510(k) NO: K140991(Traditional)ATTN: CHRISTOPHER P WHELANPHONE NO : 508 588-4400 30 Doherty Avenue, P.O. Box 635 AvSE DECISION MADE: 11-SEP-14Avon MA02322510(k) SUMMARY AVAILABLE FROM FDADEVICE: DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTUREDEMETECH CORP.510(k) NO: K141007(Traditional)ATTN: ANTHONYDIMERCURIOPHONE NO : 305 824-1048 14175 NW 60th AveSE DECISION MADE: 25-SEP-14Miami Lakes FL33014 510(k) SUMMARY AVAILABLE FROM FDADEVICE: ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KITPROCTER & GAMBLE CO.510(k) NO: K141018(Traditional)ATTN: MICHAELKAMINSKI, PH.D. PHONE NO : 513 622-2879 8700 MASON-MONTGOMERY RD.SE DECISION MADE: 15-SEP-14MASON OH45040-9462510(k) SUMMARY AVAILABLE FROM FDADEVICE: ARTIMES BALLOON DILATATION CATHETERBROSMED MEDICAL 510(k) NO: K141025(Traditional)ATTN: STEPHENLEE PHONE NO : 86 769 22892018 15TH-BUILDING,SMES VENTURE PARK,SOSE DECISION MADE: 12-SEP-14DONGGUAN, GUANGDONGCN 523808 510(k) SUMMARY AVAILABLE FROM FDADEVICE: SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIVARGENTUM MEDICAL, LLC 510(k) NO: K141033(Traditional)ATTN: C. RICHARDFOSTER PHONE NO : 630 232-2507 2571 KANEVILLE COURTSE DECISION MADE: 12-SEP-14GENEVA IL60134510(k) SUMMARY AVAILABLE FROM FDADEVICE: ZEISS CATARACT SUITE MARKERLESSCARL ZEISS MEDITEC AG 510(k) NO: K141068(Traditional)ATTN: SARAHHARRINGTONPHONE NO : 925 560-5134 5160 HACIENDA DRIVESE DECISION MADE: 09-SEP-14DUBLIN CA94568510(k) SUMMARY AVAILABLE FROM FDADEVICE: Lung Density AnalysisIMBIO LLC 510(k) NO: K141069(Traditional)ATTN: JASONSHEARDPHONE NO : 612 520-7360 227 COLFAX AVE N SUITE 144SE DECISION MADE: 17-SEP-14MINNEAPOLIS MN55405 510(k) SUMMARY AVAILABLE FROM FDADEVICE: CORTEX ID SUITEGE MEDICAL SYSTEMS, LLC510(k) NO: K141074(Traditional)ATTN: DAVIDDUERSTELERPHONE NO : 262 312-7029 3000 N GRANDVIEW BLVD.SE DECISION MADE: 18-SEP-14WAUKESHA WI53188 510(k) SUMMARY AVAILABLE FROM FDADEVICE: SINGLE-SITE WRISTED NEEDLE DRIVERINTUITIVE SURGICAL 510(k) NO: K141075(Traditional)ATTN: EINAVYEMINIPHONE NO : 408 523-2656 1266 KIFER ROAD SE DECISION MADE: 26-SEP-14SUNNYVALE CA94086510(k) SUMMARY AVAILABLE FROM FDADEVICE: ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX)ORTHOFIX SRL 510(k) NO: K141078(Traditional)ATTN: CHERYLWAGONER PHONE NO : 910 356-9019 PO BOX 15729 SE DECISION MADE: 02-SEP-14WILMINGTON NC28408510(k) SUMMARY AVAILABLE FROM FDADEVICE: OPTIMEDICA CATALYS PRECISION LASER SYSTEMOPTIMEDICA CORPORATION510(k) NO: K141079(Traditional)ATTN: STEVEJWANOUSKOSPHONE NO : 408 771-7218 1310 MOFFETT PARK DRIVESE DECISION MADE: 11-SEP-14SUNNYVALE CA94089510(k) SUMMARY AVAILABLE FROM FDADEVICE: CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USETOUCHSTONE INTERNATIONAL MEDICAL S510(k) NO: K141097(Traditional)ATTN: JOQIAOPHONE NO : 86 512629 91985 21A SCIENCE PLAZA, INTRENATIONAL SSE DECISION MADE: 26-SEP-14SUZHOU, JIANGSUCN 215021510(k) SUMMARY AVAILABLE FROM FDADEVICE: INTRAMEDULLARY NAIL AND SCREWS-NEONAILNEOORTHO PRODUTOS ORTOPEDICOS S/A 510(k) NO: K141103(Traditional)ATTN: KEVIN A THOMASPHONE NO : 858 792-1235 11234 EL CAMINO REAL SUITE 400 SE DECISION MADE: 23-SEP-14SAN DIEGO CA92130510(k) SUMMARY AVAILABLE FROM FDADEVICE: YUSHENGZIBO YUSHENG PLASTIC PRODUCTS CO.,510(k) NO: K141108(Traditional)ATTN: CHUXIAOANPHONE NO : 861 082 387441 ROOM 1606 BLDG. 1. JINAXIANG YUAN SE DECISION MADE: 16-SEP-14BEJINGCN 100083510(k) SUMMARY AVAILABLE FROM FDADEVICE: SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVESPACELABS HEALTHCARE LTD.510(k) NO: K141113(Special)ATTN: ALVAN HOUDTPHONE NO : 425 363597 0 PO BOX 3018SE DECISION MADE: 26-SEP-14NEDERLAND CO80466510(k) SUMMARY AVAILABLE FROM FDADEVICE: HARMONIC SCALLOP BLADE, GENERATOR G11ETHICON ENDO-SURGERY, LLC510(k) NO: K141122(Traditional)ATTN: EMILYKRUETZKAMPPHONE NO : 513 337-1546 4545 CREEK ROAD SE DECISION MADE: 15-SEP-14CINCINNATI OH45242510(k) SUMMARY AVAILABLE FROM FDADEVICE: STEREOS WORKSTATIONEOS IMAGING510(k) NO: K141137(Traditional)ATTN: JOHN J SMITH PHONE NO : 202 637-3638 555 THIRTEENTH STREET, NWSE DECISION MADE: 15-SEP-14WASHINGTON DC20004510(k) SUMMARY AVAILABLE FROM FDADEVICE: COMP A-I-ROMRON HEALTHCARE, INC.510(k) NO: K141140(Traditional)ATTN: PAULDRYDEN PHONE NO : 239 498-2155 24301 WOODSAGE DR. SE DECISION MADE: 30-SEP-14BONITA SPRINGS FL34134 510(k) SUMMARY AVAILABLE FROM FDADEVICE: STA LIATEST D-DIDIAGNOSTICA STAGO510(k) NO: K141144(Traditional)ATTN: CARLOD'ALESSANDROPHONE NO : 39 06 5782665 PIAZZA ALBANIA 10SE DECISION MADE: 03-SEP-14ITALAYIT 00153510(k) SUMMARY AVAILABLE FROM FDADEVICE: PTA BALLOON DILATATION CATHETERBOSTON SCIENTIFIC CORP.510(k) NO: K141150(Traditional)ATTN: CarolTiffanyPHONE NO : ONE SCIMED PLACESE DECISION MADE: 25-SEP-14MAPLE GROVE MN55311-1566510(k) SUMMARY AVAILABLE FROM FDADEVICE: SPACELABS HEALTHCARE TELEMETRY RECEIVERSPACELABS HEALTHCARE510(k) NO: K141156(Traditional)ATTN: THOMASKROENKE PHONE NO : 303 956-4232 P.O. BOX 3018SE DECISION MADE: 09-SEP-14NEDERLAND CO80466510(k) SUMMARY AVAILABLE FROM FDADEVICE: PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMSMICROPORT ORTHOPEDICS INC.510(k) NO: K141235(Traditional)ATTN: BYRONLEDBETTERPHONE NO : 866 872-0211 5677 AIRLINE RD SE DECISION MADE: 12-SEP-14ARLINGTON TN38002510(k) SUMMARY AVAILABLE FROM FDADEVICE: NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES)NORTH AMERICAN SCIENCE ASSOC., INC510(k) NO: K141244(Traditional)ATTN: JULIEWHEELERPHONE NO : 419 666-9455 6750 WALES RD.SE DECISION MADE: 09-SEP-14NORTHWOOD OH43619510(k) SUMMARY AVAILABLE FROM FDADEVICE: SMART SEGMENTATION KNOWLEDGE BASED CONTOURINGVARIAN MEDICAL SYSTEMS, INC.510(k) NO: K141248(Traditional)ATTN: PETER J CORONADOPHONE NO : 650 424-6320 3100 HANSEN WAY SE DECISION MADE: 05-SEP-14PALO ALTO CA94304510(k) SUMMARY AVAILABLE FROM FDADEVICE: SIMEX SUBGLOTTIC ASPIRATION SYSTEMSIMEX MEDIZINTECHNIK GMBH510(k) NO: K141255(Traditional)ATTN: HAMIDKHOSROWSHAHIPHONE NO : 914 772-7326 P.O. BOX 123 SE DECISION MADE: 22-SEP-14TARRYTOWN NY10591510(k) SUMMARY AVAILABLE FROM FDADEVICE: ELECTRONIC PULSE STIMULATORSHENZHEN JINGKEHUI ELECTRONIC CO.,510(k) NO: K141260(Traditional)ATTN: BILL QUANQINDAIPHONE NO : 508 723-6334 513 PIAZZA DR. UNIT B SE DECISION MADE: 17-SEP-14MOUNTAIN VIEW CA94043510(k) SUMMARY AVAILABLE FROM FDADEVICE: AERODR SYSTEM 2KONICA MINOLTA, INC.510(k) NO: K141271(Traditional)ATTN: RUSSELL D MUNVESPHONE NO : 212 497-8208 140 EAST 45TH STREET 25TH FLOORSE DECISION MADE: 26-SEP-14NEW YORK NY10017 510(k) SUMMARY AVAILABLE FROM FDADEVICE: FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATORMINIMMALLYINVASIVE DEVICES510(k) NO: K141272(Traditional)ATTN: TRUDIE L SEEGER, PH.D.PHONE NO : 614 484-5036 1275 KINNEAR AVE.SE DECISION MADE: 04-SEP-14COLUMBUS OH43026 510(k) SUMMARY AVAILABLE FROM FDADEVICE: AER-O-SCOPE COLONOSCOPE SYSTEMGI VIEW LTD. 510(k) NO: K141286(Traditional)ATTN: MARKHELLER PHONE NO : 202 346-4107 901 NEW YORK AVENUE, N.W SE DECISION MADE: 30-SEP-14WASHINGTON D.C DC20001 510(k) SUMMARY AVAILABLE FROM FDADEVICE: HELICAL RIDGE PEEK INTERFERENCE SCREWMEDSHAPE, INC510(k) NO: K141290(Traditional)ATTN: JACKGRIFFISPHONE NO : 678 235-3311 1575 NORTHSIDE DRIVE NW SUITE 440 SE DECISION MADE: 29-SEP-14ATLANTA GA30318510(k) SUMMARY AVAILABLE FROM FDADEVICE: PHOT-X IIS MODEL 505TAKARA BELMONT CORPORATION510(k) NO: K141293(Traditional)ATTN: ROBERTSCHIFFPHONE NO : 973 227-1830 1120 BLOOMFILED AVE.SE DECISION MADE: 03-SEP-14WEST CALDWELL NJ07006510(k) SUMMARY AVAILABLE FROM FDADEVICE: SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATIONSPINEART510(k) NO: K141314(Traditional)ATTN: FRANCKPENNESI PHONE NO : 41 22 7994025 INTERNATIONAL CENTER COINTRIN 20 RSE DECISION MADE: 29-SEP-14GENEVACH 1215 510(k) SUMMARY AVAILABLE FROM FDADEVICE: GLUCOSTABILIZER INSULIN DOSING CALCULATORMEDICAL DECISION NETWORK 510(k) NO: K141321(Traditional)ATTN: JANEKEATHLEYPHONE NO : 434 409-3535 2657 CORALBERRY PL SE DECISION MADE: 15-SEP-14CHARLOTTESVILLE VA22911510(k) SUMMARY AVAILABLE FROM FDADEVICE: ARENA-CSPINEFRONTIER, INC.510(k) NO: K141337(Traditional)ATTN: MEREDITHMAY MS, RAC PHONE NO : 719 337-7579 4628 NORTHPARK DRIVESE DECISION MADE: 08-SEP-14COLORADO SPRINGS CO80918510(k) SUMMARY AVAILABLE FROM FDADEVICE: AXXENT CERVICAL APPLICATORICAD, INC.510(k) NO: K141343(Traditional)ATTN: JohnDeLuciaPHONE NO : 603 882-5200 794598 SPIT BROOK ROAD SUITE 100SE DECISION MADE: 05-SEP-14NASHUA NH03062510(k) SUMMARY AVAILABLE FROM FDADEVICE: VOLUMETRIC INCENTIVE SPIROMETERBESMED HEALTH BUSINESS CORPORATION510(k) NO: K141355(Traditional)ATTN: PAULDRYDEN PHONE NO : 239 4982155 No. 5, Lane 116, Wu-Kong 2nd Rd. WSE DECISION MADE: 03-SEP-14New Taipei CityTW 24888510(k) SUMMARY AVAILABLE FROM FDADEVICE: CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBESMAUNA KEA TECHNOLOGIES510(k) NO: K141358(Traditional)ATTN: MICHAEL A DANIELPHONE NO : 415 407-0223 340 Jones LaneSE DECISION MADE: 25-SEP-14Gardnerville NV89460510(k) SUMMARY AVAILABLE FROM FDADEVICE: RENOVIS CEMENTED HIP SYSTEMRenovis Surgical Technologies, Inc510(k) NO: K141370(Traditional)ATTN: SharynOrtonPHONE NO : 401 330-8264 200 HOMER AVE.SE DECISION MADE: 02-SEP-14ASHLAND MA01721510(k) SUMMARY AVAILABLE FROM FDADEVICE: PROVOX FREEHANDS FLEXIVOICEATOS MEDICAL AB 510(k) NO: K141380(Traditional)ATTN: FERENCDAHNERPHONE NO : 46 415 198 00 KRAFTGATAN 8 SE DECISION MADE: 26-SEP-14HORBYSE SE-24222 510(k) SUMMARY AVAILABLE FROM FDADEVICE: WHISPERJECT AUTOINJECTORSCANDINAVIAN HEALTH LIMITED 510(k) NO: K141384(Third Party - Abbreviated)ATTN: JamesHaynesPHONE NO : 954 725-2046 #588 JIM MORAN BLVDSE DECISION MADE: 12-SEP-14DEERFIELD BEACH FL33442510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MOBIS II ST SPINAL IMPLANTSIGNUS MEDIZINTECHNIK GMBH510(k) NO: K141405(Traditional)ATTN: J.D.WEBBPHONE NO : 512 388-0199 1001 OAKWOOD BLVD. SE DECISION MADE: 16-SEP-14ROUND ROCK TX78681510(k) SUMMARY AVAILABLE FROM FDADEVICE: ZVPLASTYZAVATION LLC 510(k) NO: K141419(Traditional)ATTN: JOHNWALKER PHONE NO : 601 919-1119 400 LIBERTY PARK DRSE DECISION MADE: 12-SEP-14FLOWOOD MS39232510(k) SUMMARY AVAILABLE FROM FDADEVICE: PROFLUORO FLUORIDE VARNISHPAC-DENT INTERNATIONAL, INC.510(k) NO: K141422(Traditional)ATTN: WENYINGZHU PHONE NO : 909 839-0888 21038 Commerce Pointe Dr.SE DECISION MADE: 30-SEP-14Walnut CA91789510(k) SUMMARY AVAILABLE FROM FDADEVICE: ELITE + LASER SYSTEMCYNOSURE, INC.510(k) NO: K141425(Special)ATTN: KELLIMCMILLAN PHONE NO : 781 993-2454 5 CARLISLE ROAD SE DECISION MADE: 11-SEP-14WESTFORD MA01886 510(k) SUMMARY AVAILABLE FROM FDADEVICE: XLR8 PLUS (XLR8+)GENADYNE BIOTECHNOLOGIES, INC. 510(k) NO: K141437(Special)ATTN: CHIENMING, GOHPHONE NO : 516 487-8787 16 MIDLAND AVESE DECISION MADE: 19-SEP-14HICKSVILLE NY11801510(k) SUMMARY AVAILABLE FROM FDADEVICE: ORTHODONTIC ACRYLIC (NOT FINALIZED)BISCO, INC.510(k) NO: K141439(Traditional)ATTN: MichelleSchiltz-TaingPHONE NO : 847 534-6146 1100 WEST IRVING PARK RD.SE DECISION MADE: 12-SEP-14SCHAUMBURG IL60193510(k) SUMMARY AVAILABLE FROM FDADEVICE: AXIOM 2.8ANTHOGYR SAS 510(k) NO: K141450(Abbreviated)ATTN: THERESECANDAU PHONE NO : 33 4 50580237 2237, AVENUE ANDRE LASQUINSE DECISION MADE: 17-SEP-14SALLANCHESFR 74700510(k) SUMMARY AVAILABLE FROM FDADEVICE: ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETERLIGHTLAB IMAGING, INC.510(k) NO: K141453(Traditional)ATTN: JEFFREYROBERTSPHONE NO : 978 577-3451 4 ROBBINS ROADSE DECISION MADE: 19-SEP-14WESTFORD MA01886 510(k) SUMMARY AVAILABLE FROM FDADEVICE: NOVAGUARD S A SAFETY SYSTEMWEST PHARMACEUTICAL SERVICES510(k) NO: K141464(Traditional)ATTN: KEVINLENTZ PHONE NO : 610 594-4353 530 HERMAN O. WEST DRIVE SE DECISION MADE: 10-SEP-14EXTON PA19341-1147510(k) SUMMARY AVAILABLE FROM FDADEVICE: VANTAGE ELANTOSHIBA AMERICA MEDICAL SYSTEMS IN510(k) NO: K141472(Traditional)ATTN: PAULBIGGINSPHONE NO : 714 669-7808 2441 MICHELLE DRIVESE DECISION MADE: 19-SEP-14TUSTIN CA92780510(k) SUMMARY AVAILABLE FROM FDADEVICE: WAVELIGHT FS200 LASER SYSTEMALCON RESEARCH, LTD. DBA ALCON LAB510(k) NO: K141476(Traditional)ATTN: BobLundbergPHONE NO : 949 5057817 6201 SOUTH FREEWAY SE DECISION MADE: 30-SEP-14FORT WORTH TX76134510(k) SUMMARY AVAILABLE FROM FDADEVICE: DISCOVERY IQGE MEDICAL SYSTEMS, LLC510(k) NO: K141477(Traditional)ATTN: HUYDOAN PHONE NO : 262 312-7751 3000 N GRANDVIEW BLVD.SE DECISION MADE: 18-SEP-14WAUKESHA WI53188 510(k) SUMMARY AVAILABLE FROM FDADEVICE: TRC-NW400 NON-MYDRIATIC RETINAL CAMERATOPCON CORPORATION 510(k) NO: K141481(Traditional)ATTN: MAUREENO'CONNELL PHONE NO : 978 207-1245 5 TIMBER LANESE DECISION MADE: 17-SEP-14NORTH READING MA01864510(k) SUMMARY AVAILABLE FROM FDADEVICE: BIOSPACE BODY COMPOSITION ANALYZERBIOSPACE CORPORATION LIMITED510(k) NO: K141483(Traditional)ATTN: DANIELKAMM PHONE NO : 239 234-1735 8870 RAVELLO CT SE DECISION MADE: 23-SEP-14NAPLES FL34114510(k) SUMMARY AVAILABLE FROM FDADEVICE: UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SETVARIAN MEDICAL SYSTEMS, INC.510(k) NO: K141490(Traditional)ATTN: PETER J CORONADOPHONE NO : 650 424-6230 3100 HANSEN WAY SE DECISION MADE: 26-SEP-14PALO ALTO CA94304510(k) SUMMARY AVAILABLE FROM FDADEVICE: TRUWAVE DISPOSABLE PRESSURE TRANSDUCEREDWARDS LIFESCIENCES, LLC.510(k) NO: K141495(Traditional)ATTN: ANDREW S MAZURKIEWICZ, JRPHONE NO : 949 250-5176 ONE EDWARDS WAY SE DECISION MADE: 03-SEP-14IRVINE CA92614510(k) SUMMARY AVAILABLE FROM FDADEVICE: OPTIO-C ANTERIOR CERVICAL SYSTEMZIMMER SPINE, INC. 510(k) NO: K141500(Traditional)ATTN: DONNA M SEMLAKPHONE NO : 952 857-5643 7375 Bush Lake RdSE DECISION MADE: 23-SEP-14Minneapolis MN55439 510(k) SUMMARY AVAILABLE FROM FDADEVICE: SYNAPSE 3D TENSOR ANALYSISFUJIFILM MEIDCAL SYSTEMS U.S.A..,I510(k) NO: K141514(Traditional)ATTN: JYH-SHYANLINPHONE NO : 301 251-1092 149 WEST AVENUE SE DECISION MADE: 03-SEP-14STAMFORD CT06902 510(k) SUMMARY AVAILABLE FROM FDADEVICE: XIDF-AWS801, ANGIO WORKSTATION, V5.31TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K141541(Traditional)ATTN: PAULBIGGINSPHONE NO : 714 669-7808 2441 MICHELLE DRIVESE DECISION MADE: 08-SEP-14TUSTIN CA92780510(k) SUMMARY AVAILABLE FROM FDADEVICE: VITALOGRAPH MODEL 7000 SPIROTRACVITALOGRAPH(IRELAND) LTD.510(k) NO: K141546(Third Party - Traditional)ATTN: TOM J HEALYPHONE NO : 35 365 6864100 ENNIS INDUSTRIAL ESTATE GORT ROAD SE DECISION MADE: 03-SEP-14ENNIS, CO. CLAREIE510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: WINGMAN EXTENDABLE TIP SUPPORT CATHETERREFLOW MEDICAL510(k) NO: K141547(Traditional)ATTN: Rebecca K PinePHONE NO : 760 809-5178 1003 Calle SombraSE DECISION MADE: 30-SEP-14San Clemente CA92673510(k) SUMMARY AVAILABLE FROM FDADEVICE: PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)STRYKER CORPORATE510(k) NO: K141551(Traditional)ATTN: BECKYDITTY PHONE NO : 269 389-3434 4100 E. MILHAM AVE.SE DECISION MADE: 08-SEP-14KALAMAZOO MI49001510(k) SUMMARY AVAILABLE FROM FDADEVICE: ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMSCAREFUSION510(k) NO: K141552(Traditional)ATTN: JOYGREIDANUSPHONE NO : 847 362-8103 75 NORTH FAIRWAY DRIVESE DECISION MADE: 05-SEP-14VERNON HILLS IL60061510(k) SUMMARY AVAILABLE FROM FDADEVICE: MSN-006GC AMERICA, INC.510(k) NO: K141562(Traditional)ATTN: MARKHEISSPHONE NO : 708 926-3090 3737 WEST 127TH ST.SE DECISION MADE: 05-SEP-14ALSIP IL60803 510(k) SUMMARY AVAILABLE FROM FDADEVICE: GLOBE-TROTTER GT5400Draeger Medical Systems, Inc.510(k) NO: K141565(Traditional)ATTN: GALEWINARSKYPHONE NO : 215 660-2239 3135 QUARRY RD. SE DECISION MADE: 10-SEP-14TELFORD PA18969510(k) SUMMARY AVAILABLE FROM FDADEVICE: MOSAIQ ONCOLOGY INFORMATION SYSTEMIMPAC MEDICAL SYSTEMS, INC. 510(k) NO: K141572(Traditional)ATTN: KATHRYNSTINSONPHONE NO : 314 993-0003 100 MATHILDA PLACE, 5TH FLOORSE DECISION MADE: 05-SEP-14SUNNYVALE CA94086510(k) SUMMARY AVAILABLE FROM FDADEVICE: ARTIS ZEE/ZEEGO SW VC21SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K141574(Special)ATTN: PATRICIA D JONESPHONE NO : 610 448-3536 51 VALLEY STREAM PKWY.SE DECISION MADE: 05-SEP-14MALVERN PA19355-1406510(k) SUMMARY AVAILABLE FROM FDADEVICE: EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREEECO MEDI GLOVE SDN. BHD510(k) NO: K141590(Traditional)ATTN: SURESHKUMARPHONE NO : 603 602 83033 LOT 23826, JALAN TEMBAGA KUNING, KSE DECISION MADE: 03-SEP-14TAIPING, PERAKMY 34600 510(k) SUMMARY AVAILABLE FROM FDADEVICE: SMARTGRAFT 30 SYSTEMINGENERON, INC. 510(k) NO: K141591(Traditional)ATTN: ANITAKADALAPHONE NO : 713 440-9900 8205 EL RIOSE DECISION MADE: 24-SEP-14HOUSTON TX77054510(k) SUMMARY AVAILABLE FROM FDADEVICE: FUSE COLONOSCOPY SYSTEMENDOCHOICE, INC.510(k) NO: K141598(Special)ATTN: TAMARFUERSTPHONE NO : 972 4636 7321 3 HATOCHEN ST., BUSINESS AND INDUSSE DECISION MADE: 30-SEP-14CAESAREAIL 3088900510(k) SUMMARY AVAILABLE FROM FDADEVICE: IASSIST KNEE SYSTEMZIMMER CAS510(k) NO: K141601(Special)ATTN: CHRISTOPHERMCLEANPHONE NO : 514 861 4047X231 75 QUEEN STREET, SUITE 3300 SE DECISION MADE: 11-SEP-14MONTREALCA H3C 2N6510(k) SUMMARY AVAILABLE FROM FDADEVICE: DX-D IMAGING PACKAGEAGFA HEALTHCARE N.V.510(k) NO: K141602(Traditional)ATTN: SHAEANNCAVANAGHPHONE NO : 864 421-1766 10 SOUTH ACADEMY ST.SE DECISION MADE: 12-SEP-14GREENVILLE SC29601510(k) SUMMARY AVAILABLE FROM FDADEVICE: DENTAL IMAGING SOFTWARETROPHY 510(k) NO: K141607(Traditional)ATTN: MARIE-PIERRELABAT-CAMY PHONE NO : 331 648 08500 4 RUE F. PELLOUTIER CROISSY - BEAUSE DECISION MADE: 18-SEP-14MARNE LA VALLEE CEDEX 2FR 77435 510(k) STATEMENTDEVICE: STERILIZATION CASSETTEOTICON MEDICAL AB510(k) NO: K141616(Traditional)ATTN: CAROL A WESSLINGPHONE NO : 463 174 86100 EKONOMIVAGEN 2SE DECISION MADE: 23-SEP-14ASKIMSE SE-436 33510(k) SUMMARY AVAILABLE FROM FDADEVICE: PRO-PICC WITH VALVE TECHNOLOGYMEDICAL COMPONENTS INC510(k) NO: K141633(Traditional)ATTN: JONATHANSCHELLPHONE NO : 215 256-4201 22711499 DELP DRIVE SE DECISION MADE: 29-SEP-14HARLEYSVILLE PA19438510(k) SUMMARY AVAILABLE FROM FDADEVICE: ARTHREX IBALANCE TKA SYSTEMARTHREX, INC.510(k) NO: K141635(Traditional)ATTN: LEONBROWN IIPHONE NO : 239 643-5553 72021370 CREEKSIDE BLVD.SE DECISION MADE: 03-SEP-14NAPLES FL34108-1945 510(k) SUMMARY AVAILABLE FROM FDADEVICE: PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPEPROPPER MANUFACTURING CO.,INC. 510(k) NO: K141638(Abbreviated)ATTN: ANDREWSHARAVARAPHONE NO : 718 392-6650 36-04 SKILLMAN AVENUE SE DECISION MADE: 17-SEP-14LONG ISLAND CITY NY11101510(k) SUMMARY AVAILABLE FROM FDADEVICE: SURGIMAPNEMARIS INC510(k) NO: K141669(Traditional)ATTN: KEITHBARRITTPHONE NO : 202 626-6433 1425 K STREET N.W. 11TH FLOORSE DECISION MADE: 19-SEP-14WASHINGTON DC20005510(k) SUMMARY AVAILABLE FROM FDADEVICE: ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIAJOHNSON & JOHNSON VISION CARE, INC510(k) NO: K141670(Traditional)ATTN: SCOTTDURLANDPHONE NO : 904 443-3458 7500 CENTURION PARKWAY, SUITE 100 SE DECISION MADE: 18-SEP-14JACKSONVILLE FL32256510(k) SUMMARY AVAILABLE FROM FDADEVICE: IVAS 8 GAUGE BONE BIOPSY KITSTRYKER CORPORATION510(k) NO: K141673(Special)ATTN: BRITTNEY L LARSENPHONE NO : 269 389-5293 4100 E. MILHAM AVE.SE DECISION MADE: 04-SEP-14KALAMAZOO MI49001510(k) SUMMARY AVAILABLE FROM FDADEVICE: EDWARDS ESHEATH INTRODUCER SETEDWARDS LIFESCIENCES510(k) NO: K141696(Traditional)ATTN: NEILDELANEYPHONE NO : 949 250-2562 ONE EDWARDS WAY SE DECISION MADE: 18-SEP-14IRVINE CA92614510(k) SUMMARY AVAILABLE FROM FDADEVICE: XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEMZIMMER, INC. 510(k) NO: K141697(Traditional)ATTN: ROMILSHETH PHONE NO : 574 371-1621 P.O. BOX 708 SE DECISION MADE: 18-SEP-14WARSAW IN46581-0708 510(k) SUMMARY AVAILABLE FROM FDADEVICE: ECARE COORDINATOR (ECC)VISICU, INC. 510(k) NO: K141706(Third Party - Traditional)ATTN: CHRISFERGUSON PHONE NO : 410 276-1960 217 E. REDWOOD ST., STE. 1900SE DECISION MADE: 09-SEP-14BALTIMORE MD21202510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BIOGEL PL MICRO SURGICAL GLOVEMOLNLYCKE HEALTH CARE, US LLC510(k) NO: K141719(Special)ATTN: CURTISTRUESDALEPHONE NO : 678 250-7829 5550 PEACHTREE PARKWAY, SUITE 500 SE DECISION MADE: 04-SEP-14NORCROSS GA30092 510(k) SUMMARY AVAILABLE FROM FDADEVICE: PERFRACTIONSUN NUCLEAR CORPORATION510(k) NO: K141800(Traditional)ATTN: JEFFKAPATOESPHONE NO : 321 259-6862 3275 SUNTREE BOULEVARDSE DECISION MADE: 26-SEP-14MELBOURNE FL32940510(k) SUMMARY AVAILABLE FROM FDADEVICE: POLARIS SPINAL SYSTEM - HA COATEDBIOMET SPINE LLC,510(k) NO: K141804(Traditional)ATTN: KIMBERLYMCCOY PHONE NO : 303 465-8923 310 Interlocken Pkwy Ste 120SE DECISION MADE: 25-SEP-14BROOMFIELD CO80021510(k) SUMMARY AVAILABLE FROM FDADEVICE: CLEAR GUIDE ONECLEAR GUIDE MEDICAL510(k) NO: K141806(Traditional)ATTN: JACKKENTPHONE NO : 410 504-6540 40 WARRENTON ROADSE DECISION MADE: 19-SEP-14BALTIMORE MD21210510(k) SUMMARY AVAILABLE FROM FDADEVICE: MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIPMEDTRONIC SOFAMOR DANEK, INC.510(k) NO: K141824(Traditional)ATTN: COURTNEY N LONG PHONE NO : 800 876-3133 1800 PYRAMID PLACE SE DECISION MADE: 05-SEP-14MEMPHIS TN38132510(k) SUMMARY AVAILABLE FROM FDADEVICE: GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEMCERAGEM MEDISYS INC.510(k) NO: K141829(Special)ATTN: Hak-SungKimPHONE NO : 82 41 5298422 16 JEONGJA1-GIL, SEONGGEO-EUP, SEOSE DECISION MADE: 24-SEP-14CHEONAN, CHUNGCHEONGNAM-DOKR 331510(k) SUMMARY AVAILABLE FROM FDADEVICE: HYDRAVIEW GUIDEWIREBRIVANT LIMITED 510(k) NO: K141831(Traditional)ATTN: KENNETHWALSHPHONE NO : 353 913853 91 PARKMORE WEST BUSINESS PARK SE DECISION MADE: 04-SEP-14GALWAYIE510(k) SUMMARY AVAILABLE FROM FDADEVICE: ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODSSPINE ART 510(k) NO: K141835(Special)ATTN: FRANCKPENNESI PHONE NO : 41 22 7994025 20 ROUTE DE PRE-BOIS CP1813 SE DECISION MADE: 10-SEP-14GENEVACH 1215 510(k) SUMMARY AVAILABLE FROM FDADEVICE: TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACHZIMMER, INC. 510(k) NO: K141840(Traditional)ATTN: DIANATAYLORPHONE NO : 574 267-6131 P.O. BOX 708 SE DECISION MADE: 03-SEP-14WARSAW IN46581-0708 510(k) SUMMARY AVAILABLE FROM FDADEVICE: RANGE/MESA/DENALI SPINAL SYSTEMK2M, INC. 510(k) NO: K141873(Traditional)ATTN: NANCYGLEZENPHONE NO : 703 777-3155 751 MILLER DR SESE DECISION MADE: 08-SEP-14LEESBURG VA22066 510(k) SUMMARY AVAILABLE FROM FDADEVICE: CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAYMINXRAY, INC.510(k) NO: K141885(Special)ATTN: DANIELKAMM PHONE NO : 239 234-1735 8870 RAVELLO COURT SE DECISION MADE: 18-SEP-14NAPLES FL34114510(k) SUMMARY AVAILABLE FROM FDADEVICE: MOBILEDIAGNOST WDRSEDECAL SA510(k) NO: K141895(Special)ATTN: JENNIFERCARTLEDGEPHONE NO : 864 5060097 409 WOODRIDGE DR.SE DECISION MADE: 18-SEP-14SENECA SC29672510(k) SUMMARY AVAILABLE FROM FDADEVICE: SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEMSYNTHES USA PRODUCTS, LLC510(k) NO: K141897(Traditional)ATTN: MITCHOHIWA PHONE NO : 508 828-3225 325 PARAMOUNT DRIVESE DECISION MADE: 25-SEP-14RAYHAM MA02767510(k) SUMMARY AVAILABLE FROM FDADEVICE: PRO-LINK WEDGE SYSTEMLIFE SPINE510(k) NO: K141905(Traditional)ATTN: RANDYLEWIS PHONE NO : 847 884-6117 2401 W. HASSELL RD. SUITE 1535 SE DECISION MADE: 26-SEP-14HOFFMAN ESTATES IL60169510(k) SUMMARY AVAILABLE FROM FDADEVICE: HD BLOOD PRESSURE MONITORBIOCARE ASIA CORPORATION LTD.510(k) NO: K141924(Traditional)ATTN: Ke-MinJenPHONE NO : 86 502 68091772 NO. 260, MAYUN ROAD NEW DISTRICTSE DECISION MADE: 08-SEP-14SUZHOU, JIANGSUCN 215129510(k) SUMMARY AVAILABLE FROM FDADEVICE: STRYKER S2 DRILLSTRYKER CORPORATION510(k) NO: K141935(Special)ATTN: VISHALKANANIPHONE NO : 268 389-4796 4100 E. MILHAM AVE SE DECISION MADE: 26-SEP-14KALAMAZOO MI49001510(k) SUMMARY AVAILABLE FROM FDADEVICE: TRIDENT FUSION IMPLANTVILEX IN TENNESSEE, INC. 510(k) NO: K141937(Traditional)ATTN: ABRAHAMLAVIPHONE NO : 412 389-3215 8374 MARKET STREET, #167 SE DECISION MADE: 10-SEP-14LAKEWOOD RANCH FL34202 510(k) SUMMARY AVAILABLE FROM FDADEVICE: CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUMAAP IMPLANTATE AG510(k) NO: K141949(Traditional)ATTN: CHRISTIANZIETSCH PHONE NO : 49 307501 9193 LORENZWEG 5SE DECISION MADE: 12-SEP-14BERLINDE D-12099 510(k) SUMMARY AVAILABLE FROM FDADEVICE: HFD100 ROCKER ARM ACCESSORYIMRIS, INC.510(k) NO: K141950(Special)ATTN: KARISSAHOLCOMBPHONE NO : 763 203-6411 5101 Shady Oak RdSE DECISION MADE: 04-SEP-14Minnetonka MN55343510(k) SUMMARY AVAILABLE FROM FDADEVICE: BIOGRAPH TRUE PET/CT FAMILY SOFTWARESIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K141971(Special)ATTN: ALAINEMEDIOPHONE NO : 865 218-2703 810 INNOVATION DR. SE DECISION MADE: 12-SEP-14KNOXVILLE TN37932510(k) SUMMARY AVAILABLE FROM FDADEVICE: TRUE BA V BALLOON VALVULOPLASTY CATHETERC.R. BARD, INC. 510(k) NO: K141985(Traditional)ATTN: AARONCONOVALOFFPHONE NO : 480 350-6012 1625 W.THIRD ST.SE DECISION MADE: 18-SEP-14TEMPE AZ85281 510(k) SUMMARY AVAILABLE FROM FDADEVICE: SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERSPINGHU SAMA MEDICAL PACKING CO., L510(k) NO: K141998(Traditional)ATTN: CHARLESSHENPHONE NO : 608 217-9358 853 DORCHESTER LN, UNIT-BSE DECISION MADE: 19-SEP-14NEW MILFORD NJ07646 510(k) SUMMARY AVAILABLE FROM FDADEVICE: ESOFLIP ESCROSPON, LTD.510(k) NO: K142000(Traditional)ATTN: PAULDRYDEN PHONE NO : 239 498-2155 24301 WOODSAGE DRIVESE DECISION MADE: 25-SEP-14BONITA SPRINGS FL34134 510(k) SUMMARY AVAILABLE FROM FDADEVICE: MYLABSEVEN, MYLABALPHAESAOTE S.P.A.510(k) NO: K142008(Traditional)ATTN: AllisonScottPHONE NO : 317 228-8719 9001 Wesleyan Road, Suite 200SE DECISION MADE: 12-SEP-14Indianapolis IN46268510(k) SUMMARY AVAILABLE FROM FDADEVICE: GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEMARKRAY FACTORY INC.510(k) NO: K142035(Traditional)ATTN: LONNA M DENDOOVENPHONE NO : 952 646-3175 5182 WEST 76TH STSE DECISION MADE: 05-SEP-14EDINA MN55439 510(k) SUMMARY AVAILABLE FROM FDADEVICE: EMPRINT PROCEDURE PLANNING APPLICATIONCovidien LLC 510(k) NO: K142048(Traditional)ATTN: HEATHER V NIGRO PHONE NO : 508 452-1936 15 HAMPSHIRE ST SE DECISION MADE: 17-SEP-14MANSFIELD MA02048510(k) SUMMARY AVAILABLE FROM FDADEVICE: IMACOR ZURA EVO IMAGING SYSTEMIMACOR INC.510(k) NO: K142054(Traditional)ATTN: JAMES W MONROEPHONE NO : 732 718-9199 839 STEWART AVE. STE 3SE DECISION MADE: 29-SEP-14GARDEN CITY NY11530 510(k) SUMMARY AVAILABLE FROM FDADEVICE: CLAVEGUARD FREEDOM SURGICAL LIGHTDICKSON & DICKSON HEALTHCARE (US),510(k) NO: K142076(Traditional)ATTN: RAGUNATHMUNIANDY PHONE NO : 510 439-4558 503 CANAL BLVDSE DECISION MADE: 30-SEP-14RICHMOND CA94804 510(k) SUMMARY AVAILABLE FROM FDADEVICE: MYLABGAMMAESAOTE, S.P.A.510(k) NO: K142077(Traditional)ATTN: AllisonScottPHONE NO : 317 228-8719 9001 Wesleyan Road, Suite 200SE DECISION MADE: 12-SEP-14Indianapolis IN46268510(k) SUMMARY AVAILABLE FROM FDADEVICE: DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5TGE MEDICAL SYSTEMS, LLC510(k) NO: K142085(Traditional)ATTN: JENNYWONGPHONE NO : 262 548-2899 3200 N. GRANDVIEW BLVD.SE DECISION MADE: 26-SEP-14WAUKESHA WI53188 510(k) SUMMARY AVAILABLE FROM FDADEVICE: ELI 380 ELECTROCARDIOGRAPHMORTARA INSTRUMENT, INC510(k) NO: K142105(Special)ATTN: AMYYANG PHONE NO : 414 354-1600 77277865 NORTH 86TH STREETSE DECISION MADE: 05-SEP-14MILWAUKEE WI53224510(k) SUMMARY AVAILABLE FROM FDADEVICE: 4WEB SPINAL IMPLANT PRODUCTS4WEB, INC.510(k) NO: K142112(Special)ATTN: RICHJANSEN PHONE NO : 612 281-5505 11821 BRAMBLE COVE DRIVE SE DECISION MADE: 23-SEP-14FT.MYERS FL33905 510(k) SUMMARY AVAILABLE FROM FDADEVICE: ESOPHYX2 HDENDOGASTRIC SOLUTIONS, INC. 510(k) NO: K142113(Special)ATTN: MICHAEL A DANIELPHONE NO : 775 3922970 340 JONES LANESE DECISION MADE: 30-SEP-14GARDNERVILLE NV89640510(k) SUMMARY AVAILABLE FROM FDADEVICE: REACH ACCESS TELEMEDICINE DOSE CALCULATORREACH HEALTH, INC. 510(k) NO: K142123(Traditional)ATTN: BETHDESTASIOPHONE NO : 678 436-8214 10745 WESTSIDE WAY SE DECISION MADE: 24-SEP-14Alpharetta GA30009510(k) SUMMARY AVAILABLE FROM FDADEVICE: ELECSYS ESTRADIOL III CALCHECK 5Roche Diagnostics510(k) NO: K142127(Traditional)ATTN: KELLITURNERPHONE NO : 317 521-4515 9115 HAGUE ROAD SE DECISION MADE: 05-SEP-14INDIANAPOLIS IN46250-0416 510(k) SUMMARY AVAILABLE FROM FDADEVICE: C-WIRE DOUBLE ENDED ORTHOPEDIC WIRESCONMED CORPORATION, LARGO510(k) NO: K142134(Traditional)ATTN: JOYLOVETTPHONE NO : 727 399-5137 11311 CONCEPT BLVD SE DECISION MADE: 12-SEP-14LARGO FL33773 510(k) SUMMARY AVAILABLE FROM FDADEVICE: PALACOS R+G PROHERAEUS MEDICAL GMBH510(k) NO: K142157(Special)ATTN: ASTRIDMARX PHONE NO : 496 181 352963 PHILIPP-REIS-STR. 8-13SE DECISION MADE: 05-SEP-14WEHRHEIMDE 61273 510(k) SUMMARY AVAILABLE FROM FDADEVICE: D-KAT Z-YPEKEELER LTD.510(k) NO: K142179(Special)ATTN: EUGENE R VAN ARSDALEPHONE NO : 610 353-4350 456 PARKWAYSE DECISION MADE: 17-SEP-14BROOMALL PA19008 510(k) SUMMARY AVAILABLE FROM FDADEVICE: RANDOX ALDOLASE CALIBRATION SERUMRANDOX LABORATORIES LIMITED 510(k) NO: K142181(Traditional)ATTN: PAULINEARMSTRONG PHONE NO : 440 289 4422413 55 DIAMOND RD.SE DECISION MADE: 18-SEP-14CRUMLIN, CO.ANTRIMGB BT29 4QY510(k) SUMMARY AVAILABLE FROM FDADEVICE: FRIMAP ADAPTER CONNECTOR (MAC)TOPERA, INC. 510(k) NO: K142182(Special)ATTN: DENNISPOZZOPHONE NO : 314 300-6580 3668 S. GEYER ROAD SUITE 365SE DECISION MADE: 09-SEP-14ST. LOUIS MO63127510(k) SUMMARY AVAILABLE FROM FDADEVICE: VIA SPINOUS PROCESS FIXATION SYSTEM SPINEOLOGY, INC.510(k) NO: K142213(Special)ATTN: TIMCRABTREEPHONE NO : 651 256 8534 7800 3RD STREET NORTH SE DECISION MADE: 10-SEP-14SAINT PAUL MN55128510(k) SUMMARY AVAILABLE FROM FDADEVICE: Pilot Pro Diode LaserCAO GROUP, INC. 510(k) NO: K142223(Special)ATTN: ROBERT K. LARSENPHONE NO : 801 256 9282 4628 WEST SKYHAWK DRIVESE DECISION MADE: 12-SEP-14WEST JORDAN UT84084 510(k) SUMMARY AVAILABLE FROM FDADEVICE: Pilot Elite Diode LaserCAO Group, Inc. 510(k) NO: K142225(Special)ATTN: Robert K Larsen PHONE NO : 1 801 2569282 4628 West Skyhawk DriveSE DECISION MADE: 12-SEP-14West Jordan UT84084 510(k) SUMMARY AVAILABLE FROM FDADEVICE: Pilot Ultra Diode LaserCAO GROUP, INC. 510(k) NO: K142226(Special)ATTN: ROBERT K. LARSENPHONE NO : 801 256 9282 4628 WEST SKYHAWK DRIVESE DECISION MADE: 12-SEP-14WEST JORDAN UT84084 510(k) SUMMARY AVAILABLE FROM FDADEVICE: Apollo Suture Anchor System and Titan ScrewsValeris Medical 510(k) NO: K142230(Special)ATTN: DanielLanoisPHONE NO : 1 888 4043980 101200 Cobb Pkw N,Bldg 200 Ste 210SE DECISION MADE: 10-SEP-14Marietta GA30062 510(k) SUMMARY AVAILABLE FROM FDADEVICE: LARIAT sulture Delivery DeviceSENTREHEART INC.510(k) NO: K142241(Special)ATTN: KitCariquitan PHONE NO : 1 650 2416038 300 SAGINAW DRSE DECISION MADE: 12-SEP-14REDWOOD CITY CA94063-0000 510(k) SUMMARY AVAILABLE FROM FDADEVICE: PolyCatch Retrieval DeviceMedi-Globe Corporation510(k) NO: K142258(Traditional)ATTN: ScottKarlerPHONE NO : 1 480 9872772 110 West Orion Street SE DECISION MADE: 30-SEP-14Tempe AZ85283 510(k) SUMMARY AVAILABLE FROM FDADEVICE: Direxion Torqueable MicrocatheterBOSTON SCIENTIFIC CORP.510(k) NO: K142259(Special)ATTN: MarkLanzPHONE NO : 1 763 4942895 ONE SCIMED PLACESE DECISION MADE: 10-SEP-14MAPLE GROVE MN55311 510(k) SUMMARY AVAILABLE FROM FDADEVICE: Ultraverse 035 PTA Balloon Dilatation CatheterBard Peripheral Vascular, Inc. 510(k) NO: K142261(Third Party - Traditional)ATTN: MarioThomasPHONE NO : 1 480 3506014 1625 West Third StreetSE DECISION MADE: 24-SEP-14Tempe AZ85281 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Sirius Femoral Stem, Size 30ABiomet, Inc. 510(k) NO: K142295(Special)ATTN: JasonDuggerPHONE NO : 1 574 3713857 56 East Bell Drive SE DECISION MADE: 15-SEP-14Warsaw IN46581510(k) SUMMARY AVAILABLE FROM FDADEVICE: Arrow GPSCath Balloon Dialation Catheter (150 cm)HOTSPUR TECHNOLOGIES, INC., 510(k) NO: K142300(Special)ATTN: ERICKANKERUDPHONE NO : 978 302 9467 A SUBSIDIARY OF TELEFLEX MEDICAL, SE DECISION MADE: 17-SEP-14MOUNTAIN VIEWCA94043 510(k) SUMMARY AVAILABLE FROM FDADEVICE: Flower Upper Extremity Plating SetFlower Orthopedics Corporation 510(k) NO: K142306(Traditional)ATTN: GaryBarnettPHONE NO : 1 877 7788587 100 Witmer Road, Suite 280SE DECISION MADE: 15-SEP-14Horsham PA19044510(k) SUMMARY AVAILABLE FROM FDADEVICE: GEM Flow COUPLER Device and SystemSynovis Life Technologies, Inc.510(k) NO: K142309(Special)ATTN: TroyThomePHONE NO : 1 651 7967300 2575 University Ave. West, Suite 1SE DECISION MADE: 16-SEP-14St. Paul MN55114 510(k) SUMMARY AVAILABLE FROM FDADEVICE: Veenstra Instruments VDC-506 Dose CalibratorComecer Netherlands b.v. 510(k) NO: K142325(Special)ATTN: Gert Jan KlokPHONE NO : 011 031 513416964 Madam Curieweg 1SE DECISION MADE: 18-SEP-14JoureNL 8501 XC510(k) SUMMARY AVAILABLE FROM FDADEVICE: GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring SystemARKRAY FACTORY INC.510(k) NO: K142336(Special)ATTN: KazuyaYorimitsuPHONE NO : 81 748 866901 1480 KOJI KONAN-CHOSE DECISION MADE: 17-SEP-14KOKA-SHIJP 520-3306 510(k) SUMMARY AVAILABLE FROM FDADEVICE: HEMASORB Resorbable Hemostatic Bone PuttyORTHOCON, LLC510(k) NO: K142339(Special)ATTN: Howard L SchrayerPHONE NO : 1 Bridge Street -Suite 121SE DECISION MADE: 26-SEP-14Irvington NY10533510(k) SUMMARY AVAILABLE FROM FDADEVICE: Palomar Icon Aesthetic SystemCYNOSURE, INC.510(k) NO: K142376(Special)ATTN: AllysonConnor PHONE NO : 978 3672462 5 Carlisle Road SE DECISION MADE: 24-SEP-14Westford MA01886 510(k) SUMMARY AVAILABLE FROM FDADEVICE: Optima XR200amx, Optima XR220amxGE Medical Systems, LLC510(k) NO: K142383(Special)ATTN: ChrisPaulikPHONE NO : 262 548 2010 3000 N. Grandview Blvd.SE DECISION MADE: 25-SEP-14Waukesha WI53188 510(k) SUMMARY AVAILABLE FROM FDADEVICE: Operating Room Light Handle AdapterLitex Manufacturing, Inc.510(k) NO: K142386(Traditional)ATTN: NoelGharibian PHONE NO : 1 818 5476777 1501 Sunshine DriveSE DECISION MADE: 29-SEP-14Glendale CA91208 510(k) SUMMARY AVAILABLE FROM FDADEVICE: SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K142395(Third Party - Traditional)ATTN: ShellyPearcePHONE NO : 650 6945988 685 East Middlefield RoadSE DECISION MADE: 09-SEP-14Mountain View CA94043510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Predicate III GuidewireLake Region Medical510(k) NO: K142397(Special)ATTN: MathewPexa PHONE NO : 952 4485111 340 Lake Hazeltine Dr.SE DECISION MADE: 19-SEP-14Chaska MN55318510(k) SUMMARY AVAILABLE FROM FDADEVICE: FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)POLYMED THERAPEUTICS, INC510(k) NO: K142408(Traditional)ATTN: FRANKLUOPHONE NO : 713 7777088 3040 POST OAK BLVD, SUITE 1110 SE DECISION MADE: 25-SEP-14HOUSTON TX77056510(k) SUMMARY AVAILABLE FROM FDADEVICE: Locking Stabilization Screws - 1.5 & 2.3mm & Cortical Screw - 1.8mm, Headless Compression Screw - HCS 2.0mm, HLS Plates - Square 1.0mm, Square 1.5mm, HLS Plates - Straight 1.0mm, Straight 1.5mm, 2 T-Shape 1.0mm, 2 T-Shape 1.5mm, HLS Plates - 3 T-Shape 1.0mm, 3 T-Shape 1.5mm, 4 T-Shape 1.0mm, 4 T-Shape 1.5mm, HLS Plates - T Shape Ext, Y-Shape 1.0mm, Y-Shape 1.5mm, L-Shape - Lt & RtI.T.S. GmbH510(k) NO: K142418(Traditional)ATTN: RolandJorgler PHONE NO : 43 3162 11210 Autal 28SE DECISION MADE: 26-SEP-14Lassinitzhoehe/GrazAT A-8301 510(k) SUMMARY AVAILABLE FROM FDADEVICE: EyeSuite ImagingHAAG-STREIT AG510(k) NO: K142423(Third Party - Traditional)ATTN: OscarBanzPHONE NO : 41 31978 0148 GARDENSTADTSTRASSE 10 SE DECISION MADE: 10-SEP-14KOENIZ, BERNCH CH-3098 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Extension Set with BD Q-Syte Luer Access Split SeptumACACIA, INC. 510(k) NO: K142527(Third Party - Traditional)ATTN: DANHYUN PHONE NO : 714 2570470 785 CHALLENGER STREET SE DECISION MADE: 19-SEP-14BREA CA92821510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TightRail Rotating Dilator Sheath/TightRail Mini Dilator SheathSPECTRANETICS, INC.510(k) NO: K142546(Traditional)ATTN: ChristopherMcLellan PHONE NO : 1 719 4472385 9965 FEDERAL DRIVE SE DECISION MADE: 25-SEP-14COLORADO SPRINGS CO80921510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD236TOTAL WITH SUMMARIES226TOTAL WITH STATEMENTS10
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