September 2014 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD September 2014 DEVICE: DA VINVI SURGICAL SYSTEM INTUITIVE SURGICAL, INC. 510(k) NO: K123329(Traditional) ATTN: CINDY DOMECUS PHONE NO : 650 343-4813 1450 Kifer Rd -- SE DECISION MADE: 17-SEP-14 Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IROOT FM INNOVATIVE BIOCERAMIX INC. 510(k) NO: K130312(Traditional) ATTN: QUANZU YANG PHONE NO : 604 221 6800 1628 WEST 75TH AVE. SE DECISION MADE: 18-SEP-14 VANCOUVER, BC CA V6P 6G2 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE PURNA BINA SDN BHD 510(k) NO: K130450(Traditional) ATTN: ROBERT HILL PHONE NO : 607 787 9128 PLO 5, JALAN MAHSURI, 7.5KM, JALANSE DECISION MADE: 30-SEP-14 KLUANG, JOHOR MY 86000 510(k) STATEMENT DEVICE: POWEDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) DAHOON PLASTIC CO., LTD. 510(k) NO: K130742(Traditional) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BLDG. 1 JIANXIANG YUAN NSE DECISION MADE: 10-SEP-14 BEIJING CN 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIA Blood Glucose Monitoring System (G2) HMD BIOMEDICAL, INC. 510(k) NO: K131173(Traditional) ATTN: AXEL LIN PHONE NO : 886 360 17000 #181 MINSHENG STREET SE DECISION MADE: 18-SEP-14 XINPU TOWNSHIP, HSINCHU COUNTY TW510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES MADE PLASTIC CO., LTD. 510(k) NO: K131340(Traditional) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 RM 1606 BLDG. 1. JIANXIANG YUAN NOSE DECISION MADE: 09-SEP-14 BEIJING CN 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER OSMUNDA MEDICAL DEVICE CONSULTING 510(k) NO: K131817(Traditional) ATTN: MIKE GU PHONE NO : 008 62 062321333 NO. 982 COGYUN ROAD BAIYUN DISTRICSE DECISION MADE: 26-SEP-14 GUANGZHOU, GUANGDONG CN 510420 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LONGFIAN OXYGEN CONCENTRATOR LONGFIAN SCITECH CO., LTD. 510(k) NO: K131968(Traditional) ATTN: JUN PENG PHONE NO : 305 609-4701 6840 SW 45TH LN UNIT 5 SE DECISION MADE: 05-SEP-14 MIAMI FL 33155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ITRAC CERVICAL TRACTION SYSTEM PIVOTAL HEALTH SOLUTIONS 510(k) NO: K131983(Traditional) ATTN: AARON TVEDT PHONE NO : 605 753-0110 724 OAKWOOD RD SE DECISION MADE: 10-SEP-14 WATERTOWN SD 57201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM NOVA 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-14 WALTHAM MA 02454 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AJAX DENTAL UNIT PRO DENTAL SERVICES LLC. 510(k) NO: K132245(Traditional) ATTN: JOHN NEACSU PHONE NO : 703 206-8570 1121 PLAYER WAY SE DECISION MADE: 05-SEP-14 HERNDON VA 20170 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONE PLUS IMPLANT SYSTEM OSSEOFUSE, INC. 510(k) NO: K133050(Traditional) ATTN: Priscilla Chung PHONE NO : 714 202-5789 2651 E CHAPMAN AVE STE 110 SE DECISION MADE: 19-SEP-14 FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XENMATRIX AB SURGICAL GRAFT C.R. BARD, INC. 510(k) NO: K133223(Traditional) ATTN: Tony John PHONE NO : 401 825-8692 100 CROSSINGS BLVD. SE DECISION MADE: 19-SEP-14 WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDO SMART META BIOMED, INC. 510(k) NO: K133298(Traditional) ATTN: BLIX WINSTON PHONE NO : 301 607-9185 2600 MULLINIX MILL ROAD SE DECISION MADE: 19-SEP-14 MT. AIRY MD 21771 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURESUBTRACTION LUNG TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K133324(Traditional) ATTN: PAUL BIGGINS PHONE NO : 714 730-5000 2241 MICHELLE DR SE DECISION MADE: 05-SEP-14 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER C.R. BARD, INC. 510(k) NO: K133456(Traditional) ATTN: AMY HONEY PHONE NO : 801 522-6571 605 N 5600 W SE DECISION MADE: 24-SEP-14 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLYDESDALE(R) SPINAL SYSTEM Medtronic 510(k) NO: K133577(Traditional) ATTN: LEE GRANT PHONE NO : 901 344-0807 1800 PYRAMID PLACE SE DECISION MADE: 26-SEP-14 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM EOSHEALTH, INC. 510(k) NO: K133584(Traditional) ATTN: Carrie Hetrick PHONE NO : 512 327-9997 816 CONGRESS AVE, STE 1400 SE DECISION MADE: 08-SEP-14 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION PHILIPS MEDICAL SYSTEMS 510(k) NO: K133603(Traditional) ATTN: SUSAN QUICK PHONE NO : 440 483-2291 595 MINER ROAD SE DECISION MADE: 25-SEP-14 CLEVELAND OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LONGBOW SPACER SYSTEM LIFE SPINE 510(k) NO: K133717(Traditional) ATTN: RANDY LEWIS PHONE NO : 847 884-6117 2401 Hassell Rd Ste 1535 SE DECISION MADE: 19-SEP-14 Hoffman Est IL 60169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUSCULPT CUTERA, INC. 510(k) NO: K133739(Traditional) ATTN: BRADLEY RENTON PHONE NO : 415 657-5568 3240 BAYSHORE BLVD SE DECISION MADE: 05-SEP-14 BRISBANE CA 94005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR INFOBIONIC, INC. 510(k) NO: K133753(Traditional) ATTN: CARRIE NEUBERGER PHONE NO : 415 640-3377 600 SUFFOLK STREET P.O. BOX 9719 SE DECISION MADE: 19-SEP-14 LOWELL MA 01853 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QMASTER-H/REVO TELESYSTEMS CO., LTD. 510(k) NO: K133797(Traditional) ATTN: Claude Berthoin PHONE NO : 386 672-0450 110 EAST GRANADA BLVD. SE DECISION MADE: 04-SEP-14 ORMOND BEACH FL 32176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALERE PBP2A SA/CONS CULTURE COLONY TEST ALERE SCARBOROUGH, INC 510(k) NO: K133851(Traditional) ATTN: DANIELLE A BRIGGEMAN PHONE NO : 207 730-5750 10 Southgate Road SE DECISION MADE: 03-SEP-14 Scarborough ME 04074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APOLLO BALLOON DILATATION CATHETER BROSMED MEDICAL 510(k) NO: K133852(Traditional) ATTN: STEPHEN LEE PHONE NO : 86 769 22892018 15TH-BUILDING,SMES VENTURE PARK,SOSE DECISION MADE: 19-SEP-14 DONGGUAN CN 523808 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREMIUM COUSIN BIOTECH S.A.S. 510(k) NO: K133889(Traditional) ATTN: FRANCK PELLETIER PHONE NO : 333 20 144000 8 RUE DE L ABBE BONPAIN ALLEE DES SE DECISION MADE: 04-SEP-14 WERVICQ-SUD FR 59117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEKA SMARTXIDE LASER SYSTEM EL.EN. S.P.A 510(k) NO: K133895(Traditional) ATTN: GEORGE CHO PHONE NO : 508 435-9140 2 JORDAN ROAD SE DECISION MADE: 05-SEP-14 HOPKINTON MA 01748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM GENESYS SPINE 510(k) NO: K133911(Traditional) ATTN: BRIAN J BERGERON PHONE NO : 512 381-7071 1250 CAPITAL OF TEXAS HWY SOUTH BUSE DECISION MADE: 03-SEP-14 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE Adhezion Biomedical, LLC 510(k) NO: K133963(Special) ATTN: Caridad Smith PHONE NO : 828 572-4201 ONE MERIDIAN BLVD. SUITE 1B02 SE DECISION MADE: 09-SEP-14 WYOMISSING PA 19610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUJIFILM ENDOSCOPIC CO2 REGULATOR FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K133976(Traditional) ATTN: GINA WALLJASPER PHONE NO : 973 686-2636 10 HIGH POINT DRIVE SE DECISION MADE: 09-SEP-14 WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRA. OX HANDHELD TISSUE OXIMETER VIOPTIX INC. 510(k) NO: K133983(Traditional) ATTN: GREG HOLLAND PHONE NO : 949 262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 12-SEP-14 IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHINIX NASAL FILTER RHINIX APS 510(k) NO: K134003(Traditional) ATTN: METTE MUNCH PHONE NO : 452 987 2000 SKAGENVEJ 21 SE DECISION MADE: 04-SEP-14 EGAA DK DK-8200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENERAL SPINAL SYSTEM CHANGZHOU DEAN MEDICAL INSTRUMENT 510(k) NO: K134011(Traditional) ATTN: Diana Hong PHONE NO : 86 21 22815850 P.O. BOX 120-119 SE DECISION MADE: 03-SEP-14 SHANGHAI CN 200120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO NXSTAGE MEDICAL, INC. 510(k) NO: K134019(Traditional) ATTN: LAURA F PLATH PHONE NO : 978 332-5973 350 MERRIMACK STREET SE DECISION MADE: 11-SEP-14 LAWRENCE MA 01843 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K134025(Traditional) ATTN: PAUL BIGGINS PHONE NO : 714 669-7808 2441 MICHELLE DRIVE SE DECISION MADE: 05-SEP-14 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSONIC HCM 103 SYSTEM TRANSONIC SYSTEMS, INC. 510(k) NO: K134035(Traditional) ATTN: NAVEEN THURAMALLA PHONE NO : 607 257-7256 34 Dutch Mill Rd SE DECISION MADE: 17-SEP-14 ITHACA NY 14850 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BTL-9000; BTL-9000 RADIOFREQUENCY MODULE BTL INDUSTRIES LTD 510(k) NO: K134040(Traditional) ATTN: MICHAIL M PANKRATOV PHONE NO : 617 480-4543 16 APPLETON STREET SE DECISION MADE: 10-SEP-14 WALTHAM MA 02453 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOPIX INSIDE, SOPIX2 INSIDE SOPRO - ACTEON GROUP 510(k) NO: K140013(Traditional) ATTN: RICK ROSATI PHONE NO : 800 289-6367 124 GAITHER DRIVE SUITE #140 SE DECISION MADE: 05-SEP-14 MT. LAUREL NJ 08055 510(k) STATEMENT DEVICE: TRANSONIC HCM 102 SYSTEM TRANSONIC SYSTEMS, INC. 510(k) NO: K140017(Traditional) ATTN: NAVEEN THURAMALLA PHONE NO : 607 257-5300 34 Dutch Mill Rd SE DECISION MADE: 16-SEP-14 ITHACA NY 14850 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYCRYL AUROLAB 510(k) NO: K140039(Traditional) ATTN: KRISHNA KUMAR.R PHONE NO : 91 45230 96100 NO 1, SIVAGANGAI MAIN ROAD VEERAPASE DECISION MADE: 15-SEP-14 MADURAI, TAMILNADU IN 625020 510(k) STATEMENT DEVICE: NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE HARTALEGA SDN BHD 510(k) NO: K140050(Traditional) ATTN: NURUL AISHYAH KONG PHONE NO : 603 328 03888 NO. 7, KAWASAN PERUSAHAAN SURIA SE DECISION MADE: 12-SEP-14 BESTARI JAYA MY 45600 510(k) STATEMENT DEVICE: ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED ALBAAD 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-14 OLD LYME CT 06371 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHANTOM XL INSULATED DILATORS TEDAN SURGICAL INNOVATIONS, LLC 510(k) NO: K140088(Traditional) ATTN: JOANN(DIONICIA) REBLANDO PHONE NO : 858 472-5160 12615 W AIRPORT BLVD, SUITE 200 SE DECISION MADE: 25-SEP-14 SUGAR LAND TX 77478 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM APPLIED MEDICAL TECHNOLOGY, INC. 510(k) NO: K140097(Traditional) ATTN: JOSHUA MEINKE PHONE NO : 440 7174000 8000 KATHERINE BOULEVARD SE DECISION MADE: 24-SEP-14 BRECKSVILLE OH 44141 510(k) STATEMENT DEVICE: RENAISSANCE X SYSTEM MAZOR ROBOTICS LTD 510(k) NO: K140167(Traditional) ATTN: AHAVA STEIN PHONE NO : 972 976 70002 20 HATA'AS ST. (POB 124) SE DECISION MADE: 10-SEP-14 KFAR SABA IL 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICAL DRAPE GRIFFITH-LUCAS LLC 510(k) NO: K140195(Traditional) ATTN: MIKE GU PHONE NO : 86 20 62321333 7TH FLOOR, JINGUI BUSINESS BUILDINSE DECISION MADE: 10-SEP-14 GUANGZHOU, GUANGDONG CN 510420 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORTICORE NANOVIS, LLC 510(k) NO: K140280(Traditional) ATTN: KAREN E WARDEN PHD PHONE NO : 440 729-8457 PO BOX 566 SE DECISION MADE: 05-SEP-14 CHESTERLAND OH 44026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STARBRIGHT 5% SODIUM FLUORIDE VARNISH NANOVA BIOMATERIALS, INC. 510(k) NO: K140349(Traditional) ATTN: ANDREW RITTS PHONE NO : 573 875-6682 3806 MOJAVE CT SE DECISION MADE: 22-SEP-14 COLUMBIA MO 65202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES KATALYST SURGICAL, LLC 510(k) NO: K140362(Traditional) ATTN: MONA DEAN PHONE NO : 636 536-5950 754 Goddard ave SE DECISION MADE: 15-SEP-14 Chesterfield MO 63005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX HARBOR MEDTECH, INC. 510(k) NO: K140367(Traditional) ATTN: JERRY MEZGER PHONE NO : 949 679-4800 4 JENNER SUITE 190 SE DECISION MADE: 12-SEP-14 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLINE NEURO SPONGE MEDLINE INDUSTRIES, INC. 510(k) NO: K140369(Traditional) ATTN: MATT CLAUSEN PHONE NO : 847 643-4785 ONE MEDLINE PLACE SE DECISION MADE: 26-SEP-14 MUNDELEIN IL 60006 510(k) STATEMENT DEVICE: FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT) ABBOTT DIABETES CARE INC. 510(k) NO: K140371(Traditional) ATTN: MICHELLE RICAFORT PHONE NO : 510 749-5250 1360 SOUTH LOOP ROAD SE DECISION MADE: 30-SEP-14 ALAMEDA CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K140377(Traditional) ATTN: Tina Ip PHONE NO : 416 593 4323 439 UNIVERSITY AVE. SE DECISION MADE: 16-SEP-14 TORONTO, ONTARIO CA M5G 1Y8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT OMNIGUIDE, INC. 510(k) NO: K140378(Traditional) ATTN: NICOLE RASMUSSEN PHONE NO : 617 551-8556 ONE KENDALL SQUARE SUITE B1301 SE DECISION MADE: 25-SEP-14 CAMBRIDGE MA 02139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPERA SWING GENERAL MEDICAL MERATE S.P.A. 510(k) NO: K140380(Traditional) ATTN: BERTHOIN CLAUDE PHONE NO : 877 509-3180 110 E. GRANADA BLVD SUITE 209 SE DECISION MADE: 26-SEP-14 ORMOND BEACH FL 32176 510(k) STATEMENT DEVICE: TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS BIOMET MANUFACTURING CORP. 510(k) NO: K140390(Traditional) ATTN: BRIAN KINCAID PHONE NO : 574 372-3992 56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 10-SEP-14 WARSAW IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBM IDO VIEWER EBM TECHNOLOGIES USA, LLC 510(k) NO: K140399(Traditional) ATTN: JOHN SU PHONE NO : 808 945-3100 641 Keeaumoku St Ste 5 SE DECISION MADE: 18-SEP-14 Honolulu HI 96814 510(k) STATEMENT DEVICE: TREKKER, TREKKER TRANSIT CONVAID PRODUCTS, INC. 510(k) NO: K140416(Traditional) ATTN: DONALD GRIGGS PHONE NO : 310 618-0111 2830 CALIFORNIA ST. SE DECISION MADE: 17-SEP-14 TORRANCE CA 90503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE WRP RUBBER PRODUCTS SDN BHD 510(k) NO: K140418(Traditional) ATTN: LIM CHIN YIT PHONE NO : 60 16695 7817 LOT 3, JALAN 3, KAWASAN PERUSAHAANSE DECISION MADE: 03-SEP-14 SEPANG ,SELANGOR DARUL EHSAN MY 4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRANE ACRYLIC HERBST APPLIANCE CRANE DENTAL LABORATORY, INC. 510(k) NO: K140429(Traditional) ATTN: KATE YOUNG PHONE NO : 585 730-5100 200 AIRPARK DRIVE, SUITE 30 SE DECISION MADE: 11-SEP-14 ROCHESTER NY 14624 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTACT LENS CASE MACA PLASTICS, INC. 510(k) NO: K140488(Traditional) ATTN: CORRINA CULBERTSON PHONE NO : 937 544-8618 3455 CROSS ROAD SE DECISION MADE: 10-SEP-14 WINCHESTER OH 45697 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 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 Reagents BECKMAN COULTER, INC. 510(k) NO: K140496(Special) ATTN: NANETTE CANEPA PHONE NO : 714 961-3136 250 S. KRAEMER BLVD. MAIL STOP E1.SE DECISION MADE: 16-SEP-14 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUE BEAM, TRUE BEAM STX, EDGE VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K140528(Traditional) ATTN: PETER J CORONADO PHONE NO : 650 424-6320 3100 HANSEN WAY SE DECISION MADE: 05-SEP-14 PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONCHASMART BREATHING CIRCUIT TELEFLEX, INC. 510(k) NO: K140556(Traditional) ATTN: Amanda Webb PHONE NO : 919 433-8050 2917 WECK DR. SE DECISION MADE: 24-SEP-14 RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIVI 6F GUIDE CATHETER MIVI, LLC 510(k) NO: K140557(Traditional) ATTN: MICHELLE STRAIGHT PHONE NO : 763 577-9600 10900 73RD AVE NE, SUITE 150 SE DECISION MADE: 18-SEP-14 MAPLE GROVE MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K140608(Special) ATTN: SIOBHAN KING PHONE NO : 353 917 03700 PARKMORE BUSINESS PARK WEST SE DECISION MADE: 12-SEP-14 GALWAY IE EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM ELLIPSE TECHNOLOGIES INC. 510(k) NO: K140613(Traditional) ATTN: John McIntyre PHONE NO : 949 837-3600 13900 ALTON PKWY STE 123 SE DECISION MADE: 18-SEP-14 IRVINE CA 92618-0000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit Devon Medical, Inc. 510(k) NO: K140634(Traditional) ATTN: Steve XU PHONE NO : 866 446-0092 4272 1100 First Avenue, Suite 202 SE DECISION MADE: 19-SEP-14 King of Prussia PA 19406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ ELLIPSE A/S 510(k) NO: K140670(Traditional) ATTN: OLE KOFOD PHONE NO : 45 451 76863 AGERN ALLE 11 SE DECISION MADE: 25-SEP-14 HOERSHOLM DK DK-2970 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K140690(Traditional) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 706-7456 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 02-SEP-14 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMET GRAFT DELIVERY SYRINGES BIOMET SPINE (AKA EBI, LLC) 510(k) NO: K140710(Traditional) ATTN: DEBRA L BING PHONE NO : 973 299-9300 3964 399 JEFFERSON ROAD SE DECISION MADE: 04-SEP-14 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICOSURE WORKSTATION CYNOSURE, INC. 510(k) NO: K140719(Traditional) ATTN: KEVIN O'CONNELL PHONE NO : 978 367-8736 5 CALISLE ROAD SE DECISION MADE: 22-SEP-14 WESTFORD MA 01886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M-PM-DISC (PINK) MERZ DENTAL GMBH 510(k) NO: K140758(Traditional) ATTN: RICHARD G HUNTER PHONE NO : 505 400-4992 5616 MARIOLA PL NE SE DECISION MADE: 15-SEP-14 ALBUQUERQUE NM 87111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KEGEL SMART, KEGELSMART PEARL REGULATORY INSIGHT, INC. 510(k) NO: K140780(Traditional) ATTN: Kevin Walls PHONE NO : 720 962-5412 33 Golden Eagle Lane SE DECISION MADE: 10-SEP-14 Littleton CO 80127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XENCO MEDICAL CERVICAL INTERBODY SYSTEM XENCO MEDICAL, LLC 510(k) NO: K140786(Traditional) ATTN: GUSTAVO R PRADO PHONE NO : 858 202-1522 9930 MESA RIM DRIVE SE DECISION MADE: 03-SEP-14 SAN DIEGO CA 92121 510(k) STATEMENT DEVICE: VDRIVE WITH V-LOOP/ VDRIVE DUO STEREOTAXIS, INC. 510(k) NO: K140804(Traditional) ATTN: DIANE HORWITZ, PH.D., RAC PHONE NO : 703 307-2921 2995 STEVEN MARTIN DR, SE DECISION MADE: 03-SEP-14 FAIRFAX VA 22031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUCID LY BIO-MED USA INC. 510(k) NO: K140837(Traditional) ATTN: YOUNG CHI PHONE NO : 973 278-5222 27 NEW ENGLAND DRIVE SE DECISION MADE: 24-SEP-14 RAMSEY NJ 07446 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TABLO CARTRIDGE HOME DIALYSIS PLUS 510(k) NO: K140841(Traditional) ATTN: NANCY GALLO PHONE NO : 510 682-6505 257 HUMBOLDT COURT SE DECISION MADE: 11-SEP-14 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFRARED HEATING DEVICE PRO MEDICAL SUPPLIES, INC. 510(k) NO: K140865(Traditional) ATTN: DORIS DONG PHONE NO : 862 131 261348 ROOM 1706, NO. 128 SONGLE RD. SONGSE DECISION MADE: 03-SEP-14 SHANGHAI CN 201600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TABLO CONSOLE HOME DIALYSIS PLUS 510(k) NO: K140866(Traditional) ATTN: NANCY GALLO PHONE NO : 510 682-6505 257 HUMBOLDT COURT SE DECISION MADE: 10-SEP-14 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF SHANGHAI GOAHUI RUBBER AND PLASTIC510(k) NO: K140874(Traditional) ATTN: RHONDA ALEXANDER, MS, MPA PHONE NO : 757 224-0177 144 RESEARCG DRIVE SE DECISION MADE: 02-SEP-14 HAMPTON VA 23666 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERICORE ZIRCONIA BLANKS WHIP MIX CORP. 510(k) NO: K140877(Traditional) ATTN: JOHN WATERS PHONE NO : 502 634-5357 361 FARMINGTON AVE SE DECISION MADE: 03-SEP-14 LOUISVILLE KY 40217 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM BECKMAN COULTER, INC. 510(k) NO: K140911(Abbreviated) ATTN: BRENT LEMBERG PHONE NO : 305 380-4509 11800 SW 147TH AVE. SE DECISION MADE: 05-SEP-14 MIAMI FL 33196 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMATOM SCOPE/SOMATOM SCOPE POWER SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K140912(Traditional) ATTN: EVE DAVIS PHONE NO : 610 219-7133 51 VALLEY STREAM PKWY. SE DECISION MADE: 15-SEP-14 MALVERN PA 19355-1406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABPM7100 I.E.M. GMBH 510(k) NO: K140928(Traditional) ATTN: ARNE BRIEST PHONE NO : 492 402950 00 COCKERILLSTRASSE 69 SE DECISION MADE: 15-SEP-14 STOLBERG DE D-52222 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPAT ENTERAL DELIVERY PUMP SETS NESTLE HEALTHCARE NUTRITION, INC. 510(k) NO: K140947(Traditional) ATTN: M.W.(ANDY) ANDERSON PHONE NO : 952 746-8079 5353 WAYZATA BOULEVARD, SUITE 505 SE DECISION MADE: 04-SEP-14 MINNEAPOLIS MN 55416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALCULASE II KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K140964(Traditional) ATTN: WINKIE WONG PHONE NO : 424 218-8379 2151 E. GRAND AVE. SE DECISION MADE: 04-SEP-14 EL SEGUNDO CA 90245-5017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE RANFAC CORP. 510(k) NO: K140991(Traditional) ATTN: CHRISTOPHER P WHELAN PHONE NO : 508 588-4400 30 Doherty Avenue, P.O. Box 635 AvSE DECISION MADE: 11-SEP-14 Avon MA 02322 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE DEMETECH CORP. 510(k) NO: K141007(Traditional) ATTN: ANTHONY DIMERCURIO PHONE NO : 305 824-1048 14175 NW 60th Ave SE DECISION MADE: 25-SEP-14 Miami Lakes FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT PROCTER & GAMBLE CO. 510(k) NO: K141018(Traditional) ATTN: MICHAEL KAMINSKI, PH.D. PHONE NO : 513 622-2879 8700 MASON-MONTGOMERY RD. SE DECISION MADE: 15-SEP-14 MASON OH 45040-9462 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTIMES BALLOON DILATATION CATHETER BROSMED MEDICAL 510(k) NO: K141025(Traditional) ATTN: STEPHEN LEE PHONE NO : 86 769 22892018 15TH-BUILDING,SMES VENTURE PARK,SOSE DECISION MADE: 12-SEP-14 DONGGUAN, GUANGDONG CN 523808 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV ARGENTUM MEDICAL, LLC 510(k) NO: K141033(Traditional) ATTN: C. RICHARD FOSTER PHONE NO : 630 232-2507 2571 KANEVILLE COURT SE DECISION MADE: 12-SEP-14 GENEVA IL 60134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZEISS CATARACT SUITE MARKERLESS CARL ZEISS MEDITEC AG 510(k) NO: K141068(Traditional) ATTN: SARAH HARRINGTON PHONE NO : 925 560-5134 5160 HACIENDA DRIVE SE DECISION MADE: 09-SEP-14 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Lung Density Analysis IMBIO LLC 510(k) NO: K141069(Traditional) ATTN: JASON SHEARD PHONE NO : 612 520-7360 227 COLFAX AVE N SUITE 144 SE DECISION MADE: 17-SEP-14 MINNEAPOLIS MN 55405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORTEX ID SUITE GE MEDICAL SYSTEMS, LLC 510(k) NO: K141074(Traditional) ATTN: DAVID DUERSTELER PHONE NO : 262 312-7029 3000 N GRANDVIEW BLVD. SE DECISION MADE: 18-SEP-14 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINGLE-SITE WRISTED NEEDLE DRIVER INTUITIVE SURGICAL 510(k) NO: K141075(Traditional) ATTN: EINAV YEMINI PHONE NO : 408 523-2656 1266 KIFER ROAD SE DECISION MADE: 26-SEP-14 SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX) ORTHOFIX SRL 510(k) NO: K141078(Traditional) ATTN: CHERYL WAGONER PHONE NO : 910 356-9019 PO BOX 15729 SE DECISION MADE: 02-SEP-14 WILMINGTON NC 28408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIMEDICA CATALYS PRECISION LASER SYSTEM OPTIMEDICA CORPORATION 510(k) NO: K141079(Traditional) ATTN: STEVE JWANOUSKOS PHONE NO : 408 771-7218 1310 MOFFETT PARK DRIVE SE DECISION MADE: 11-SEP-14 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE TOUCHSTONE INTERNATIONAL MEDICAL S510(k) NO: K141097(Traditional) ATTN: JO QIAO PHONE NO : 86 512629 91985 21A SCIENCE PLAZA, INTRENATIONAL SSE DECISION MADE: 26-SEP-14 SUZHOU, JIANGSU CN 215021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAMEDULLARY NAIL AND SCREWS-NEONAIL NEOORTHO PRODUTOS ORTOPEDICOS S/A 510(k) NO: K141103(Traditional) ATTN: KEVIN A THOMAS PHONE NO : 858 792-1235 11234 EL CAMINO REAL SUITE 400 SE DECISION MADE: 23-SEP-14 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: YUSHENG ZIBO YUSHENG PLASTIC PRODUCTS CO.,510(k) NO: K141108(Traditional) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BLDG. 1. JINAXIANG YUAN SE DECISION MADE: 16-SEP-14 BEJING CN 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE SPACELABS HEALTHCARE LTD. 510(k) NO: K141113(Special) ATTN: AL VAN HOUDT PHONE NO : 425 363597 0 PO BOX 3018 SE DECISION MADE: 26-SEP-14 NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARMONIC SCALLOP BLADE, GENERATOR G11 ETHICON ENDO-SURGERY, LLC 510(k) NO: K141122(Traditional) ATTN: EMILY KRUETZKAMP PHONE NO : 513 337-1546 4545 CREEK ROAD SE DECISION MADE: 15-SEP-14 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STEREOS WORKSTATION EOS IMAGING 510(k) NO: K141137(Traditional) ATTN: JOHN J SMITH PHONE NO : 202 637-3638 555 THIRTEENTH STREET, NW SE DECISION MADE: 15-SEP-14 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMP A-I-R OMRON HEALTHCARE, INC. 510(k) NO: K141140(Traditional) ATTN: PAUL DRYDEN PHONE NO : 239 498-2155 24301 WOODSAGE DR. SE DECISION MADE: 30-SEP-14 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STA LIATEST D-DI DIAGNOSTICA STAGO 510(k) NO: K141144(Traditional) ATTN: CARLO D'ALESSANDRO PHONE NO : 39 06 5782665 PIAZZA ALBANIA 10 SE DECISION MADE: 03-SEP-14 ITALAY IT 00153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PTA BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K141150(Traditional) ATTN: Carol Tiffany PHONE NO : ONE SCIMED PLACE SE DECISION MADE: 25-SEP-14 MAPLE GROVE MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPACELABS HEALTHCARE TELEMETRY RECEIVER SPACELABS HEALTHCARE 510(k) NO: K141156(Traditional) ATTN: THOMAS KROENKE PHONE NO : 303 956-4232 P.O. BOX 3018 SE DECISION MADE: 09-SEP-14 NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS MICROPORT ORTHOPEDICS INC. 510(k) NO: K141235(Traditional) ATTN: BYRON LEDBETTER PHONE NO : 866 872-0211 5677 AIRLINE RD SE DECISION MADE: 12-SEP-14 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES) NORTH AMERICAN SCIENCE ASSOC., INC510(k) NO: K141244(Traditional) ATTN: JULIE WHEELER PHONE NO : 419 666-9455 6750 WALES RD. SE DECISION MADE: 09-SEP-14 NORTHWOOD OH 43619 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART SEGMENTATION KNOWLEDGE BASED CONTOURING VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K141248(Traditional) ATTN: PETER J CORONADO PHONE NO : 650 424-6320 3100 HANSEN WAY SE DECISION MADE: 05-SEP-14 PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMEX SUBGLOTTIC ASPIRATION SYSTEM SIMEX MEDIZINTECHNIK GMBH 510(k) NO: K141255(Traditional) ATTN: HAMID KHOSROWSHAHI PHONE NO : 914 772-7326 P.O. BOX 123 SE DECISION MADE: 22-SEP-14 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTRONIC PULSE STIMULATOR SHENZHEN JINGKEHUI ELECTRONIC CO.,510(k) NO: K141260(Traditional) ATTN: BILL QUANQIN DAI PHONE NO : 508 723-6334 513 PIAZZA DR. UNIT B SE DECISION MADE: 17-SEP-14 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AERODR SYSTEM 2 KONICA MINOLTA, INC. 510(k) NO: K141271(Traditional) ATTN: RUSSELL D MUNVES PHONE NO : 212 497-8208 140 EAST 45TH STREET 25TH FLOOR SE DECISION MADE: 26-SEP-14 NEW YORK NY 10017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATOR MINIMMALLY INVASIVE DEVICES 510(k) NO: K141272(Traditional) ATTN: TRUDIE L SEEGER, PH.D. PHONE NO : 614 484-5036 1275 KINNEAR AVE. SE DECISION MADE: 04-SEP-14 COLUMBUS OH 43026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AER-O-SCOPE COLONOSCOPE SYSTEM GI VIEW LTD. 510(k) NO: K141286(Traditional) ATTN: MARK HELLER PHONE NO : 202 346-4107 901 NEW YORK AVENUE, N.W SE DECISION MADE: 30-SEP-14 WASHINGTON D.C DC 20001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HELICAL RIDGE PEEK INTERFERENCE SCREW MEDSHAPE, INC 510(k) NO: K141290(Traditional) ATTN: JACK GRIFFIS PHONE NO : 678 235-3311 1575 NORTHSIDE DRIVE NW SUITE 440 SE DECISION MADE: 29-SEP-14 ATLANTA GA 30318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHOT-X IIS MODEL 505 TAKARA BELMONT CORPORATION 510(k) NO: K141293(Traditional) ATTN: ROBERT SCHIFF PHONE NO : 973 227-1830 1120 BLOOMFILED AVE. SE DECISION MADE: 03-SEP-14 WEST CALDWELL NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION SPINEART 510(k) NO: K141314(Traditional) ATTN: FRANCK PENNESI PHONE NO : 41 22 7994025 INTERNATIONAL CENTER COINTRIN 20 RSE DECISION MADE: 29-SEP-14 GENEVA CH 1215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOSTABILIZER INSULIN DOSING CALCULATOR MEDICAL DECISION NETWORK 510(k) NO: K141321(Traditional) ATTN: JANE KEATHLEY PHONE NO : 434 409-3535 2657 CORALBERRY PL SE DECISION MADE: 15-SEP-14 CHARLOTTESVILLE VA 22911 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARENA-C SPINEFRONTIER, INC. 510(k) NO: K141337(Traditional) ATTN: MEREDITH MAY MS, RAC PHONE NO : 719 337-7579 4628 NORTHPARK DRIVE SE DECISION MADE: 08-SEP-14 COLORADO SPRINGS CO 80918 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXXENT CERVICAL APPLICATOR ICAD, INC. 510(k) NO: K141343(Traditional) ATTN: John DeLucia PHONE NO : 603 882-5200 7945 98 SPIT BROOK ROAD SUITE 100 SE DECISION MADE: 05-SEP-14 NASHUA NH 03062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOLUMETRIC INCENTIVE SPIROMETER BESMED HEALTH BUSINESS CORPORATION510(k) NO: K141355(Traditional) ATTN: PAUL DRYDEN PHONE NO : 239 4982155 No. 5, Lane 116, Wu-Kong 2nd Rd. WSE DECISION MADE: 03-SEP-14 New Taipei City TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES 510(k) NO: K141358(Traditional) ATTN: MICHAEL A DANIEL PHONE NO : 415 407-0223 340 Jones Lane SE DECISION MADE: 25-SEP-14 Gardnerville NV 89460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENOVIS CEMENTED HIP SYSTEM Renovis Surgical Technologies, Inc510(k) NO: K141370(Traditional) ATTN: Sharyn Orton PHONE NO : 401 330-8264 200 HOMER AVE. SE DECISION MADE: 02-SEP-14 ASHLAND MA 01721 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROVOX FREEHANDS FLEXIVOICE ATOS MEDICAL AB 510(k) NO: K141380(Traditional) ATTN: FERENC DAHNER PHONE NO : 46 415 198 00 KRAFTGATAN 8 SE DECISION MADE: 26-SEP-14 HORBY SE SE-24222 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WHISPERJECT AUTOINJECTOR SCANDINAVIAN HEALTH LIMITED 510(k) NO: K141384(Third Party - Abbreviated) ATTN: James Haynes PHONE NO : 954 725-2046 #588 JIM MORAN BLVD SE DECISION MADE: 12-SEP-14 DEERFIELD BEACH FL 33442 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MOBIS II ST SPINAL IMPLANT SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K141405(Traditional) ATTN: J.D. WEBB PHONE NO : 512 388-0199 1001 OAKWOOD BLVD. SE DECISION MADE: 16-SEP-14 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZVPLASTY ZAVATION LLC 510(k) NO: K141419(Traditional) ATTN: JOHN WALKER PHONE NO : 601 919-1119 400 LIBERTY PARK DR SE DECISION MADE: 12-SEP-14 FLOWOOD MS 39232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFLUORO FLUORIDE VARNISH PAC-DENT INTERNATIONAL, INC. 510(k) NO: K141422(Traditional) ATTN: WENYING ZHU PHONE NO : 909 839-0888 21038 Commerce Pointe Dr. SE DECISION MADE: 30-SEP-14 Walnut CA 91789 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELITE + LASER SYSTEM CYNOSURE, INC. 510(k) NO: K141425(Special) ATTN: KELLI MCMILLAN PHONE NO : 781 993-2454 5 CARLISLE ROAD SE DECISION MADE: 11-SEP-14 WESTFORD MA 01886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XLR8 PLUS (XLR8+) GENADYNE BIOTECHNOLOGIES, INC. 510(k) NO: K141437(Special) ATTN: CHIEN MING, GOH PHONE NO : 516 487-8787 16 MIDLAND AVE SE DECISION MADE: 19-SEP-14 HICKSVILLE NY 11801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHODONTIC ACRYLIC (NOT FINALIZED) BISCO, INC. 510(k) NO: K141439(Traditional) ATTN: Michelle Schiltz-Taing PHONE NO : 847 534-6146 1100 WEST IRVING PARK RD. SE DECISION MADE: 12-SEP-14 SCHAUMBURG IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXIOM 2.8 ANTHOGYR SAS 510(k) NO: K141450(Abbreviated) ATTN: THERESE CANDAU PHONE NO : 33 4 50580237 2237, AVENUE ANDRE LASQUIN SE DECISION MADE: 17-SEP-14 SALLANCHES FR 74700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER LIGHTLAB IMAGING, INC. 510(k) NO: K141453(Traditional) ATTN: JEFFREY ROBERTS PHONE NO : 978 577-3451 4 ROBBINS ROAD SE DECISION MADE: 19-SEP-14 WESTFORD MA 01886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVAGUARD S A SAFETY SYSTEM WEST PHARMACEUTICAL SERVICES 510(k) NO: K141464(Traditional) ATTN: KEVIN LENTZ PHONE NO : 610 594-4353 530 HERMAN O. WEST DRIVE SE DECISION MADE: 10-SEP-14 EXTON PA 19341-1147 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANTAGE ELAN TOSHIBA AMERICA MEDICAL SYSTEMS IN510(k) NO: K141472(Traditional) ATTN: PAUL BIGGINS PHONE NO : 714 669-7808 2441 MICHELLE DRIVE SE DECISION MADE: 19-SEP-14 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAVELIGHT FS200 LASER SYSTEM ALCON RESEARCH, LTD. DBA ALCON LAB510(k) NO: K141476(Traditional) ATTN: Bob Lundberg PHONE NO : 949 5057817 6201 SOUTH FREEWAY SE DECISION MADE: 30-SEP-14 FORT WORTH TX 76134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISCOVERY IQ GE MEDICAL SYSTEMS, LLC 510(k) NO: K141477(Traditional) ATTN: HUY DOAN PHONE NO : 262 312-7751 3000 N GRANDVIEW BLVD. SE DECISION MADE: 18-SEP-14 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRC-NW400 NON-MYDRIATIC RETINAL CAMERA TOPCON CORPORATION 510(k) NO: K141481(Traditional) ATTN: MAUREEN O'CONNELL PHONE NO : 978 207-1245 5 TIMBER LANE SE DECISION MADE: 17-SEP-14 NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSPACE BODY COMPOSITION ANALYZER BIOSPACE CORPORATION LIMITED 510(k) NO: K141483(Traditional) ATTN: DANIEL KAMM PHONE NO : 239 234-1735 8870 RAVELLO CT SE DECISION MADE: 23-SEP-14 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K141490(Traditional) ATTN: PETER J CORONADO PHONE NO : 650 424-6230 3100 HANSEN WAY SE DECISION MADE: 26-SEP-14 PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER EDWARDS LIFESCIENCES, LLC. 510(k) NO: K141495(Traditional) ATTN: ANDREW S MAZURKIEWICZ, JR PHONE NO : 949 250-5176 ONE EDWARDS WAY SE DECISION MADE: 03-SEP-14 IRVINE CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIO-C ANTERIOR CERVICAL SYSTEM ZIMMER SPINE, INC. 510(k) NO: K141500(Traditional) ATTN: DONNA M SEMLAK PHONE NO : 952 857-5643 7375 Bush Lake Rd SE DECISION MADE: 23-SEP-14 Minneapolis MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNAPSE 3D TENSOR ANALYSIS FUJIFILM MEIDCAL SYSTEMS U.S.A..,I510(k) NO: K141514(Traditional) ATTN: JYH-SHYAN LIN PHONE NO : 301 251-1092 149 WEST AVENUE SE DECISION MADE: 03-SEP-14 STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIDF-AWS801, ANGIO WORKSTATION, V5.31 TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K141541(Traditional) ATTN: PAUL BIGGINS PHONE NO : 714 669-7808 2441 MICHELLE DRIVE SE DECISION MADE: 08-SEP-14 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITALOGRAPH MODEL 7000 SPIROTRAC VITALOGRAPH(IRELAND) LTD. 510(k) NO: K141546(Third Party - Traditional) ATTN: TOM J HEALY PHONE NO : 35 365 6864100 ENNIS INDUSTRIAL ESTATE GORT ROAD SE DECISION MADE: 03-SEP-14 ENNIS, CO. CLARE IE 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: WINGMAN EXTENDABLE TIP SUPPORT CATHETER REFLOW MEDICAL 510(k) NO: K141547(Traditional) ATTN: Rebecca K Pine PHONE NO : 760 809-5178 1003 Calle Sombra SE DECISION MADE: 30-SEP-14 San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES) STRYKER CORPORATE 510(k) NO: K141551(Traditional) ATTN: BECKY DITTY PHONE NO : 269 389-3434 4100 E. MILHAM AVE. SE DECISION MADE: 08-SEP-14 KALAMAZOO MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS CAREFUSION 510(k) NO: K141552(Traditional) ATTN: JOY GREIDANUS PHONE NO : 847 362-8103 75 NORTH FAIRWAY DRIVE SE DECISION MADE: 05-SEP-14 VERNON HILLS IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MSN-006 GC AMERICA, INC. 510(k) NO: K141562(Traditional) ATTN: MARK HEISS PHONE NO : 708 926-3090 3737 WEST 127TH ST. SE DECISION MADE: 05-SEP-14 ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLOBE-TROTTER GT5400 Draeger Medical Systems, Inc. 510(k) NO: K141565(Traditional) ATTN: GALE WINARSKY PHONE NO : 215 660-2239 3135 QUARRY RD. SE DECISION MADE: 10-SEP-14 TELFORD PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOSAIQ ONCOLOGY INFORMATION SYSTEM IMPAC MEDICAL SYSTEMS, INC. 510(k) NO: K141572(Traditional) ATTN: KATHRYN STINSON PHONE NO : 314 993-0003 100 MATHILDA PLACE, 5TH FLOOR SE DECISION MADE: 05-SEP-14 SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTIS ZEE/ZEEGO SW VC21 SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K141574(Special) ATTN: PATRICIA D JONES PHONE NO : 610 448-3536 51 VALLEY STREAM PKWY. SE DECISION MADE: 05-SEP-14 MALVERN PA 19355-1406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE ECO MEDI GLOVE SDN. BHD 510(k) NO: K141590(Traditional) ATTN: SURESH KUMAR PHONE NO : 603 602 83033 LOT 23826, JALAN TEMBAGA KUNING, KSE DECISION MADE: 03-SEP-14 TAIPING, PERAK MY 34600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTGRAFT 30 SYSTEM INGENERON, INC. 510(k) NO: K141591(Traditional) ATTN: ANITA KADALA PHONE NO : 713 440-9900 8205 EL RIO SE DECISION MADE: 24-SEP-14 HOUSTON TX 77054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUSE COLONOSCOPY SYSTEM ENDOCHOICE, INC. 510(k) NO: K141598(Special) ATTN: TAMAR FUERST PHONE NO : 972 4636 7321 3 HATOCHEN ST., BUSINESS AND INDUSSE DECISION MADE: 30-SEP-14 CAESAREA IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IASSIST KNEE SYSTEM ZIMMER CAS 510(k) NO: K141601(Special) ATTN: CHRISTOPHER MCLEAN PHONE NO : 514 861 4047X231 75 QUEEN STREET, SUITE 3300 SE DECISION MADE: 11-SEP-14 MONTREAL CA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V. 510(k) NO: K141602(Traditional) ATTN: SHAEANN CAVANAGH PHONE NO : 864 421-1766 10 SOUTH ACADEMY ST. SE DECISION MADE: 12-SEP-14 GREENVILLE SC 29601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTAL IMAGING SOFTWARE TROPHY 510(k) NO: K141607(Traditional) ATTN: MARIE-PIERRE LABAT-CAMY PHONE NO : 331 648 08500 4 RUE F. PELLOUTIER CROISSY - BEAUSE DECISION MADE: 18-SEP-14 MARNE LA VALLEE CEDEX 2 FR 77435 510(k) STATEMENT DEVICE: STERILIZATION CASSETTE OTICON MEDICAL AB 510(k) NO: K141616(Traditional) ATTN: CAROL A WESSLING PHONE NO : 463 174 86100 EKONOMIVAGEN 2 SE DECISION MADE: 23-SEP-14 ASKIM SE SE-436 33 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRO-PICC WITH VALVE TECHNOLOGY MEDICAL COMPONENTS INC 510(k) NO: K141633(Traditional) ATTN: JONATHAN SCHELL PHONE NO : 215 256-4201 2271 1499 DELP DRIVE SE DECISION MADE: 29-SEP-14 HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX IBALANCE TKA SYSTEM ARTHREX, INC. 510(k) NO: K141635(Traditional) ATTN: LEON BROWN II PHONE NO : 239 643-5553 7202 1370 CREEKSIDE BLVD. SE DECISION MADE: 03-SEP-14 NAPLES FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE PROPPER MANUFACTURING CO.,INC. 510(k) NO: K141638(Abbreviated) ATTN: ANDREW SHARAVARA PHONE NO : 718 392-6650 36-04 SKILLMAN AVENUE SE DECISION MADE: 17-SEP-14 LONG ISLAND CITY NY 11101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGIMAP NEMARIS INC 510(k) NO: K141669(Traditional) ATTN: KEITH BARRITT PHONE NO : 202 626-6433 1425 K STREET N.W. 11TH FLOOR SE DECISION MADE: 19-SEP-14 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA JOHNSON & JOHNSON VISION CARE, INC510(k) NO: K141670(Traditional) ATTN: SCOTT DURLAND PHONE NO : 904 443-3458 7500 CENTURION PARKWAY, SUITE 100 SE DECISION MADE: 18-SEP-14 JACKSONVILLE FL 32256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IVAS 8 GAUGE BONE BIOPSY KIT STRYKER CORPORATION 510(k) NO: K141673(Special) ATTN: BRITTNEY L LARSEN PHONE NO : 269 389-5293 4100 E. MILHAM AVE. SE DECISION MADE: 04-SEP-14 KALAMAZOO MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDWARDS ESHEATH INTRODUCER SET EDWARDS LIFESCIENCES 510(k) NO: K141696(Traditional) ATTN: NEIL DELANEY PHONE NO : 949 250-2562 ONE EDWARDS WAY SE DECISION MADE: 18-SEP-14 IRVINE CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM ZIMMER, INC. 510(k) NO: K141697(Traditional) ATTN: ROMIL SHETH PHONE NO : 574 371-1621 P.O. BOX 708 SE DECISION MADE: 18-SEP-14 WARSAW IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECARE COORDINATOR (ECC) VISICU, INC. 510(k) NO: K141706(Third Party - Traditional) ATTN: CHRIS FERGUSON PHONE NO : 410 276-1960 217 E. REDWOOD ST., STE. 1900 SE DECISION MADE: 09-SEP-14 BALTIMORE MD 21202 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BIOGEL PL MICRO SURGICAL GLOVE MOLNLYCKE HEALTH CARE, US LLC 510(k) NO: K141719(Special) ATTN: CURTIS TRUESDALE PHONE NO : 678 250-7829 5550 PEACHTREE PARKWAY, SUITE 500 SE DECISION MADE: 04-SEP-14 NORCROSS GA 30092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERFRACTION SUN NUCLEAR CORPORATION 510(k) NO: K141800(Traditional) ATTN: JEFF KAPATOES PHONE NO : 321 259-6862 3275 SUNTREE BOULEVARD SE DECISION MADE: 26-SEP-14 MELBOURNE FL 32940 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLARIS SPINAL SYSTEM - HA COATED BIOMET SPINE LLC, 510(k) NO: K141804(Traditional) ATTN: KIMBERLY MCCOY PHONE NO : 303 465-8923 310 Interlocken Pkwy Ste 120 SE DECISION MADE: 25-SEP-14 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEAR GUIDE ONE CLEAR GUIDE MEDICAL 510(k) NO: K141806(Traditional) ATTN: JACK KENT PHONE NO : 410 504-6540 40 WARRENTON ROAD SE DECISION MADE: 19-SEP-14 BALTIMORE MD 21210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP MEDTRONIC 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-14 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM CERAGEM MEDISYS INC. 510(k) NO: K141829(Special) ATTN: Hak-Sung Kim PHONE NO : 82 41 5298422 16 JEONGJA1-GIL, SEONGGEO-EUP, SEOSE DECISION MADE: 24-SEP-14 CHEONAN, CHUNGCHEONGNAM-DO KR 331510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDRAVIEW GUIDEWIRE BRIVANT LIMITED 510(k) NO: K141831(Traditional) ATTN: KENNETH WALSH PHONE NO : 353 913853 91 PARKMORE WEST BUSINESS PARK SE DECISION MADE: 04-SEP-14 GALWAY IE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS SPINE ART 510(k) NO: K141835(Special) ATTN: FRANCK PENNESI PHONE NO : 41 22 7994025 20 ROUTE DE PRE-BOIS CP1813 SE DECISION MADE: 10-SEP-14 GENEVA CH 1215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH ZIMMER, INC. 510(k) NO: K141840(Traditional) ATTN: DIANA TAYLOR PHONE NO : 574 267-6131 P.O. BOX 708 SE DECISION MADE: 03-SEP-14 WARSAW IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANGE/MESA/DENALI SPINAL SYSTEM K2M, INC. 510(k) NO: K141873(Traditional) ATTN: NANCY GLEZEN PHONE NO : 703 777-3155 751 MILLER DR SE SE DECISION MADE: 08-SEP-14 LEESBURG VA 22066 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY MINXRAY, INC. 510(k) NO: K141885(Special) ATTN: DANIEL KAMM PHONE NO : 239 234-1735 8870 RAVELLO COURT SE DECISION MADE: 18-SEP-14 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOBILEDIAGNOST WDR SEDECAL SA 510(k) NO: K141895(Special) ATTN: JENNIFER CARTLEDGE PHONE NO : 864 5060097 409 WOODRIDGE DR. SE DECISION MADE: 18-SEP-14 SENECA SC 29672 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM SYNTHES USA PRODUCTS, LLC 510(k) NO: K141897(Traditional) ATTN: MITCH OHIWA PHONE NO : 508 828-3225 325 PARAMOUNT DRIVE SE DECISION MADE: 25-SEP-14 RAYHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRO-LINK WEDGE SYSTEM LIFE SPINE 510(k) NO: K141905(Traditional) ATTN: RANDY LEWIS PHONE NO : 847 884-6117 2401 W. HASSELL RD. SUITE 1535 SE DECISION MADE: 26-SEP-14 HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HD BLOOD PRESSURE MONITOR BIOCARE ASIA CORPORATION LTD. 510(k) NO: K141924(Traditional) ATTN: Ke-Min Jen PHONE NO : 86 502 68091772 NO. 260, MAYUN ROAD NEW DISTRICT SE DECISION MADE: 08-SEP-14 SUZHOU, JIANGSU CN 215129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER S2 DRILL STRYKER CORPORATION 510(k) NO: K141935(Special) ATTN: VISHAL KANANI PHONE NO : 268 389-4796 4100 E. MILHAM AVE SE DECISION MADE: 26-SEP-14 KALAMAZOO MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIDENT FUSION IMPLANT VILEX IN TENNESSEE, INC. 510(k) NO: K141937(Traditional) ATTN: ABRAHAM LAVI PHONE NO : 412 389-3215 8374 MARKET STREET, #167 SE DECISION MADE: 10-SEP-14 LAKEWOOD RANCH FL 34202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM AAP IMPLANTATE AG 510(k) NO: K141949(Traditional) ATTN: CHRISTIAN ZIETSCH PHONE NO : 49 307501 9193 LORENZWEG 5 SE DECISION MADE: 12-SEP-14 BERLIN DE D-12099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HFD100 ROCKER ARM ACCESSORY IMRIS, INC. 510(k) NO: K141950(Special) ATTN: KARISSA HOLCOMB PHONE NO : 763 203-6411 5101 Shady Oak Rd SE DECISION MADE: 04-SEP-14 Minnetonka MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOGRAPH TRUE PET/CT FAMILY SOFTWARE SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K141971(Special) ATTN: ALAINE MEDIO PHONE NO : 865 218-2703 810 INNOVATION DR. SE DECISION MADE: 12-SEP-14 KNOXVILLE TN 37932 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUE BA V BALLOON VALVULOPLASTY CATHETER C.R. BARD, INC. 510(k) NO: K141985(Traditional) ATTN: AARON CONOVALOFF PHONE NO : 480 350-6012 1625 W.THIRD ST. SE DECISION MADE: 18-SEP-14 TEMPE AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS PINGHU SAMA MEDICAL PACKING CO., L510(k) NO: K141998(Traditional) ATTN: CHARLES SHEN PHONE NO : 608 217-9358 853 DORCHESTER LN, UNIT-B SE DECISION MADE: 19-SEP-14 NEW MILFORD NJ 07646 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESOFLIP ES CROSPON, LTD. 510(k) NO: K142000(Traditional) ATTN: PAUL DRYDEN PHONE NO : 239 498-2155 24301 WOODSAGE DRIVE SE DECISION MADE: 25-SEP-14 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYLABSEVEN, MYLABALPHA ESAOTE S.P.A. 510(k) NO: K142008(Traditional) ATTN: Allison Scott PHONE NO : 317 228-8719 9001 Wesleyan Road, Suite 200 SE DECISION MADE: 12-SEP-14 Indianapolis IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM ARKRAY FACTORY INC. 510(k) NO: K142035(Traditional) ATTN: LONNA M DENDOOVEN PHONE NO : 952 646-3175 5182 WEST 76TH ST SE DECISION MADE: 05-SEP-14 EDINA MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMPRINT PROCEDURE PLANNING APPLICATION Covidien LLC 510(k) NO: K142048(Traditional) ATTN: HEATHER V NIGRO PHONE NO : 508 452-1936 15 HAMPSHIRE ST SE DECISION MADE: 17-SEP-14 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMACOR ZURA EVO IMAGING SYSTEM IMACOR INC. 510(k) NO: K142054(Traditional) ATTN: JAMES W MONROE PHONE NO : 732 718-9199 839 STEWART AVE. STE 3 SE DECISION MADE: 29-SEP-14 GARDEN CITY NY 11530 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLAVEGUARD FREEDOM SURGICAL LIGHT DICKSON & DICKSON HEALTHCARE (US),510(k) NO: K142076(Traditional) ATTN: RAGUNATH MUNIANDY PHONE NO : 510 439-4558 503 CANAL BLVD SE DECISION MADE: 30-SEP-14 RICHMOND CA 94804 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYLABGAMMA ESAOTE, S.P.A. 510(k) NO: K142077(Traditional) ATTN: Allison Scott PHONE NO : 317 228-8719 9001 Wesleyan Road, Suite 200 SE DECISION MADE: 12-SEP-14 Indianapolis IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T GE MEDICAL SYSTEMS, LLC 510(k) NO: K142085(Traditional) ATTN: JENNY WONG PHONE NO : 262 548-2899 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 26-SEP-14 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELI 380 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC 510(k) NO: K142105(Special) ATTN: AMY YANG PHONE NO : 414 354-1600 7727 7865 NORTH 86TH STREET SE DECISION MADE: 05-SEP-14 MILWAUKEE WI 53224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4WEB SPINAL IMPLANT PRODUCTS 4WEB, INC. 510(k) NO: K142112(Special) ATTN: RICH JANSEN PHONE NO : 612 281-5505 11821 BRAMBLE COVE DRIVE SE DECISION MADE: 23-SEP-14 FT.MYERS FL 33905 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESOPHYX2 HD ENDOGASTRIC SOLUTIONS, INC. 510(k) NO: K142113(Special) ATTN: MICHAEL A DANIEL PHONE NO : 775 3922970 340 JONES LANE SE DECISION MADE: 30-SEP-14 GARDNERVILLE NV 89640 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REACH ACCESS TELEMEDICINE DOSE CALCULATOR REACH HEALTH, INC. 510(k) NO: K142123(Traditional) ATTN: BETH DESTASIO PHONE NO : 678 436-8214 10745 WESTSIDE WAY SE DECISION MADE: 24-SEP-14 Alpharetta GA 30009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS ESTRADIOL III CALCHECK 5 Roche Diagnostics 510(k) NO: K142127(Traditional) ATTN: KELLI TURNER PHONE NO : 317 521-4515 9115 HAGUE ROAD SE DECISION MADE: 05-SEP-14 INDIANAPOLIS IN 46250-0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES CONMED CORPORATION, LARGO 510(k) NO: K142134(Traditional) ATTN: JOY LOVETT PHONE NO : 727 399-5137 11311 CONCEPT BLVD SE DECISION MADE: 12-SEP-14 LARGO FL 33773 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALACOS R+G PRO HERAEUS MEDICAL GMBH 510(k) NO: K142157(Special) ATTN: ASTRID MARX PHONE NO : 496 181 352963 PHILIPP-REIS-STR. 8-13 SE DECISION MADE: 05-SEP-14 WEHRHEIM DE 61273 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D-KAT Z-YPE KEELER LTD. 510(k) NO: K142179(Special) ATTN: EUGENE R VAN ARSDALE PHONE NO : 610 353-4350 456 PARKWAY SE DECISION MADE: 17-SEP-14 BROOMALL PA 19008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX ALDOLASE CALIBRATION SERUM RANDOX LABORATORIES LIMITED 510(k) NO: K142181(Traditional) ATTN: PAULINE ARMSTRONG PHONE NO : 440 289 4422413 55 DIAMOND RD. SE DECISION MADE: 18-SEP-14 CRUMLIN, CO.ANTRIM GB BT29 4QY 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRIMAP ADAPTER CONNECTOR (MAC) TOPERA, INC. 510(k) NO: K142182(Special) ATTN: DENNIS POZZO PHONE NO : 314 300-6580 3668 S. GEYER ROAD SUITE 365 SE DECISION MADE: 09-SEP-14 ST. LOUIS MO 63127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIA SPINOUS PROCESS FIXATION SYSTEM SPINEOLOGY, INC. 510(k) NO: K142213(Special) ATTN: TIM CRABTREE PHONE NO : 651 256 8534 7800 3RD STREET NORTH SE DECISION MADE: 10-SEP-14 SAINT PAUL MN 55128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pilot Pro Diode Laser CAO GROUP, INC. 510(k) NO: K142223(Special) ATTN: ROBERT K. LARSEN PHONE NO : 801 256 9282 4628 WEST SKYHAWK DRIVE SE DECISION MADE: 12-SEP-14 WEST JORDAN UT 84084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pilot Elite Diode Laser CAO Group, Inc. 510(k) NO: K142225(Special) ATTN: Robert K Larsen PHONE NO : 1 801 2569282 4628 West Skyhawk Drive SE DECISION MADE: 12-SEP-14 West Jordan UT 84084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pilot Ultra Diode Laser CAO GROUP, INC. 510(k) NO: K142226(Special) ATTN: ROBERT K. LARSEN PHONE NO : 801 256 9282 4628 WEST SKYHAWK DRIVE SE DECISION MADE: 12-SEP-14 WEST JORDAN UT 84084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Apollo Suture Anchor System and Titan Screws Valeris Medical 510(k) NO: K142230(Special) ATTN: Daniel Lanois PHONE NO : 1 888 4043980 101 200 Cobb Pkw N,Bldg 200 Ste 210 SE DECISION MADE: 10-SEP-14 Marietta GA 30062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LARIAT sulture Delivery Device SENTREHEART INC. 510(k) NO: K142241(Special) ATTN: Kit Cariquitan PHONE NO : 1 650 2416038 300 SAGINAW DR SE DECISION MADE: 12-SEP-14 REDWOOD CITY CA 94063-0000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PolyCatch Retrieval Device Medi-Globe Corporation 510(k) NO: K142258(Traditional) ATTN: Scott Karler PHONE NO : 1 480 9872772 110 West Orion Street SE DECISION MADE: 30-SEP-14 Tempe AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Direxion Torqueable Microcatheter BOSTON SCIENTIFIC CORP. 510(k) NO: K142259(Special) ATTN: Mark Lanz PHONE NO : 1 763 4942895 ONE SCIMED PLACE SE DECISION MADE: 10-SEP-14 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ultraverse 035 PTA Balloon Dilatation Catheter Bard Peripheral Vascular, Inc. 510(k) NO: K142261(Third Party - Traditional) ATTN: Mario Thomas PHONE NO : 1 480 3506014 1625 West Third Street SE DECISION MADE: 24-SEP-14 Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Sirius Femoral Stem, Size 30A Biomet, Inc. 510(k) NO: K142295(Special) ATTN: Jason Dugger PHONE NO : 1 574 3713857 56 East Bell Drive SE DECISION MADE: 15-SEP-14 Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Arrow GPSCath Balloon Dialation Catheter (150 cm) HOTSPUR TECHNOLOGIES, INC., 510(k) NO: K142300(Special) ATTN: ERICK ANKERUD PHONE NO : 978 302 9467 A SUBSIDIARY OF TELEFLEX MEDICAL, SE DECISION MADE: 17-SEP-14 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Flower Upper Extremity Plating Set Flower Orthopedics Corporation 510(k) NO: K142306(Traditional) ATTN: Gary Barnett PHONE NO : 1 877 7788587 100 Witmer Road, Suite 280 SE DECISION MADE: 15-SEP-14 Horsham PA 19044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEM Flow COUPLER Device and System Synovis Life Technologies, Inc. 510(k) NO: K142309(Special) ATTN: Troy Thome PHONE NO : 1 651 7967300 2575 University Ave. West, Suite 1SE DECISION MADE: 16-SEP-14 St. Paul MN 55114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Veenstra Instruments VDC-506 Dose Calibrator Comecer Netherlands b.v. 510(k) NO: K142325(Special) ATTN: Gert Jan Klok PHONE NO : 011 031 513416964 Madam Curieweg 1 SE DECISION MADE: 18-SEP-14 Joure NL 8501 XC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System ARKRAY FACTORY INC. 510(k) NO: K142336(Special) ATTN: Kazuya Yorimitsu PHONE NO : 81 748 866901 1480 KOJI KONAN-CHO SE DECISION MADE: 17-SEP-14 KOKA-SHI JP 520-3306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMASORB Resorbable Hemostatic Bone Putty ORTHOCON, LLC 510(k) NO: K142339(Special) ATTN: Howard L Schrayer PHONE NO : 1 Bridge Street -Suite 121 SE DECISION MADE: 26-SEP-14 Irvington NY 10533 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Palomar Icon Aesthetic System CYNOSURE, INC. 510(k) NO: K142376(Special) ATTN: Allyson Connor PHONE NO : 978 3672462 5 Carlisle Road SE DECISION MADE: 24-SEP-14 Westford MA 01886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Optima XR200amx, Optima XR220amx GE Medical Systems, LLC 510(k) NO: K142383(Special) ATTN: Chris Paulik PHONE NO : 262 548 2010 3000 N. Grandview Blvd. SE DECISION MADE: 25-SEP-14 Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Operating Room Light Handle Adapter Litex Manufacturing, Inc. 510(k) NO: K142386(Traditional) ATTN: Noel Gharibian PHONE NO : 1 818 5476777 1501 Sunshine Drive SE DECISION MADE: 29-SEP-14 Glendale CA 91208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SC2000 and ACUSON X300 Diagnostic Ultrasound Systems SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K142395(Third Party - Traditional) ATTN: Shelly Pearce PHONE NO : 650 6945988 685 East Middlefield Road SE DECISION MADE: 09-SEP-14 Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Predicate III Guidewire Lake Region Medical 510(k) NO: K142397(Special) ATTN: Mathew Pexa PHONE NO : 952 4485111 340 Lake Hazeltine Dr. SE DECISION MADE: 19-SEP-14 Chaska MN 55318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 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, INC 510(k) NO: K142408(Traditional) ATTN: FRANK LUO PHONE NO : 713 7777088 3040 POST OAK BLVD, SUITE 1110 SE DECISION MADE: 25-SEP-14 HOUSTON TX 77056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 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 & Rt I.T.S. GmbH 510(k) NO: K142418(Traditional) ATTN: Roland Jorgler PHONE NO : 43 3162 11210 Autal 28 SE DECISION MADE: 26-SEP-14 Lassinitzhoehe/Graz AT A-8301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EyeSuite Imaging HAAG-STREIT AG 510(k) NO: K142423(Third Party - Traditional) ATTN: Oscar Banz PHONE NO : 41 31978 0148 GARDENSTADTSTRASSE 10 SE DECISION MADE: 10-SEP-14 KOENIZ, BERN CH CH-3098 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Extension Set with BD Q-Syte Luer Access Split Septum ACACIA, INC. 510(k) NO: K142527(Third Party - Traditional) ATTN: DAN HYUN PHONE NO : 714 2570470 785 CHALLENGER STREET SE DECISION MADE: 19-SEP-14 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath SPECTRANETICS, INC. 510(k) NO: K142546(Traditional) ATTN: Christopher McLellan PHONE NO : 1 719 4472385 9965 FEDERAL DRIVE SE DECISION MADE: 25-SEP-14 COLORADO SPRINGS CO 80921 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 236 TOTAL WITH SUMMARIES 226 TOTAL WITH STATEMENTS 10
