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Medical Devices

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
                                      

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