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U.S. Department of Health and Human Services

Medical Devices

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February 2014 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD February 2014


DEVICE: LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
LIN-ZHI INTERNATIONAL, INC.       510(k) NO: K131653(TRADITIONAL)
ATTN: BERNICE  LIN                PHONE NO : 408 732 3856   
670 ALMANOR AVENUE                SE DECISION MADE: 04-FEB-14
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTA FLASH CENTROMERE
INOVA DIAGNOSTICS, INC.           510(k) NO: K123880(TRADITIONAL)
ATTN: ANDREA  SEAMAN              PHONE NO : 858 586 9900   
9900 OLD GROVE RD.                SE DECISION MADE: 07-FEB-14
SAN DIEGO CA 92131 1638           510(k) STATEMENT

DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)
BECTON, DICKINSON AND COMPANY     510(k) NO: K132909(TRADITIONAL)
ATTN: KATIE  COYLE                PHONE NO : 410 316 4975   
7 LOVETON CIRCLE MC 614           SE DECISION MADE: 14-FEB-14
SPARKS MD 21152                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO
BIOTEST MEDICAL CORP.             510(k) NO: K133509(SPECIAL)
ATTN: ROBERT  NAWY                PHONE NO : 732 389 8112   
1 INDUSTRIAL WAY WEST/ BUILDING E,SE DECISION MADE: 21-FEB-14
EATONTOWN NJ 07724                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
PHADIA AB                         510(k) NO: K133404(SPECIAL)
ATTN: MARTIN R MANN               PHONE NO : 269 492 1957   
4169 COMMERCIAL AVE.              SE DECISION MADE: 24-FEB-14
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WONDFO MULTI-DRUG URINE TEST CUP, PANEL
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K133968(SPECIAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880   
504 EAST DIAMOND AVE. SUITE F     SE DECISION MADE: 25-FEB-14
GAITHERSBURG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STATUS DS OXY
PRINCETON BIOMEDITECH CORP.       510(k) NO: K130650(TRADITIONAL)
ATTN: KYUNG-AH  KIM               PHONE NO : 732 274 1000   
4242 U.S. HIGHWAY 1               SE DECISION MADE: 26-FEB-14
MONMOUTH JUNCTION NJ 08852 1905   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IFA 40: HEP-20-10
EUROIMMUN US                      510(k) NO: K131791(TRADITIONAL)
ATTN: MICHAEL  LOCKE              PHONE NO : 973 656 1000   
1100 THE AMERICAN ROAD            SE DECISION MADE: 26-FEB-14
MORRIS PLAINS NJ 07950            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM
THERMO FISHER SCIENTIFIC          510(k) NO: K133773(TRADITIONAL)
ATTN: CYNTHIA  KNAPP              PHONE NO : 800 871 8909   
1 THERMO FISHER WAY               SE DECISION MADE: 27-FEB-14
OAKWOOD VILLAGE OH 44146          510(k) STATEMENT

DEVICE: EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM
EPS BIO TECHNOLOGY CORP.          510(k) NO: K133647(SPECIAL)
ATTN: CYNTHIA  HUNG               PHONE NO : 886 3 6686868
NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 27-FEB-14
HSINCHU CITY,    TW 30077         510(k) STATEMENT

DEVICE: HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
ABBOTT LABORATORIES               510(k) NO: K130255(TRADITIONAL)
ATTN: JUDITH R WALLACH            PHONE NO : 847 937 1132   
100 ABBOTT PARK RD.               SE DECISION MADE: 28-FEB-14
ABBOTT PARK IL 60064 3502         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
GOLD STANDARD DIAGNOSTICS         510(k) NO: K131334(TRADITIONAL)
ATTN: NAPLEON  MONCE              PHONE NO : 530 759 8000   
2851 SPAFFORD ST                  SE DECISION MADE: 28-FEB-14
Davis CA 95618                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
ROCHE DIAGNOSTICS                 510(k) NO: K131605(TRADITIONAL)
ATTN: JANE  PHILLIPS, PHD         PHONE NO : 317 521 3338   
9115 HAGUE ROAD P.O. BOX 50416    SE DECISION MADE: 28-FEB-14
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
CERAGEM MEDISYS INC.              510(k) NO: K131727(TRADITIONAL)
ATTN: HAKSUNG  KIM                PHONE NO : 82 41 5298422
                                  SE DECISION MADE: 28-FEB-14
CHEONAN SI, CHUNGCHEONGNAM-DO    K510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHOOCIN INTRODUCER KIT
LEPU MEDICAL TECHNOLOGY (BEIJING) 510(k) NO: K123475(TRADITIONAL)
ATTN: ARTHUR  GODDARD             PHONE NO : 216 233 5722   
1531 FELTON ROAD                  SE DECISION MADE: 03-FEB-14
SOUTH EUCLID OH 44121 2722        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEROYAL SPINE SPACER SYSTEM
DEROYAL INDUSTRIES, INC.          510(k) NO: K131292(TRADITIONAL)
ATTN: KAREN E WARDEN, PHD         PHONE NO : 440 729 8457   
PO BOX 566                        SE DECISION MADE: 03-FEB-14
CHESTERLAND OH 44026 2141         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
I-FLOW LLC                        510(k) NO: K131249(TRADITIONAL)
ATTN: SHELLY  HARRIS              PHONE NO : 949 206 2707   
43 Discovery Suite 100            SE DECISION MADE: 03-FEB-14
Irvine CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDLINE SHARPS CONTAINER
MEDLINE INDUSTRIES, INC.          510(k) NO: K132767(TRADITIONAL)
ATTN: TIMUR  SELIMKHANOV          PHONE NO : 847 643 4736   
ONE MEDLINE PLACE                 SE DECISION MADE: 03-FEB-14
MUNDELEIN IL 60060                510(k) STATEMENT

DEVICE: SARNS HIGH FLOW AORTIC ARCH CANNULA
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K133151(TRADITIONAL)
ATTN: GARRY A COURTNEY            PHONE NO : 800 262 3304   
125 BLUE BALL RD.                 SE DECISION MADE: 03-FEB-14
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JULIET LL LATERAL LUMBAR CAGE
SPINEART                          510(k) NO: K133557(TRADITIONAL)
ATTN: FRANCK  PENNESI             PHONE NO : 41 22 7994025
COINTRIN 20 ROUTE DE PRE-BOIS CP18SE DECISION MADE: 03-FEB-14
GENEVA    SZ 1215                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW
COVIDIEN                          510(k) NO: K130320(TRADITIONAL)
ATTN: ELIZABETH  MALO             PHONE NO : 303 305 2763   
6135 GUNBARREL AVE.               SE DECISION MADE: 04-FEB-14
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
HEZE CITY GREEN FOOD CO., LTD.    510(k) NO: K130582(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 86 10 82387441
RM 1606 BLDG, 1 JIAN XIANG YUAN NOSE DECISION MADE: 04-FEB-14
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STREAMLINE EXPRESS
NXSTAGE MEDICAL, INC.             510(k) NO: K132602(TRADITIONAL)
ATTN: MARY LOU  STROUMBOS         PHONE NO : 978 687 4872   
350 MERRIMACK STREET              SE DECISION MADE: 04-FEB-14
LAWRENCE MA 01843                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER
DUTECK INDUSTRIAL CO., LTD.       510(k) NO: K132140(TRADITIONAL)
ATTN: JOSEPH  CHEN                PHONE NO : 886 2 87975035
3F-2, NO. 26, 513 LANE JUI-KUANG RSE DECISION MADE: 04-FEB-14
TAIPEI    TW 114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM
SMITH & NEPHEW, INC.              510(k) NO: K132886(TRADITIONAL)
ATTN: DAVID  HENLEY               PHONE NO : 901 399 6487   
1450 BROOKS RD.                   SE DECISION MADE: 04-FEB-14
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER
GYRUS ACMI, INC.                  510(k) NO: K132383(TRADITIONAL)
ATTN: NEIL  KELLY                 PHONE NO : 508 804 2600   
136 TURNPIKE RD.                  SE DECISION MADE: 04-FEB-14
SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K133794(TRADITIONAL)
ATTN: TATYANA  KORSUNSKY          PHONE NO : 508 828 3122   
325 PARAMOUNT DR.                 SE DECISION MADE: 04-FEB-14
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER(R)  PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION
ZIMMER, INC.                      510(k) NO: K133737(TRADITIONAL)
ATTN: PAULINE A SHAND             PHONE NO : 574 372 4765   
P.O. BOX 708                      SE DECISION MADE: 04-FEB-14
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GFS II STANDARD, GFS II LARGE, GFS MIMI
PARCUS MEDICAL, LLC               510(k) NO: K133757(SPECIAL)
ATTN: PAUL  VAGTS                 PHONE NO : 941 755 7965   
6423 PARKLAND DRIVE               SE DECISION MADE: 04-FEB-14
SARASOTA FL 34243                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONILASE LIGHT THERAPY DEVICE
BIORENEW LABS, LLC                510(k) NO: K132613(TRADITIONAL)
ATTN: SUSAN  ANTHONEY             PHONE NO : 865 329 6882   
2424 DEMPSTER DRIVE               SE DECISION MADE: 05-FEB-14
CORALVILLE IA 52241               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RT016 INSPIRATORY FILTER
FISHER & PAYKEL HEALTHCARE LTD.   510(k) NO: K133666(TRADITIONAL)
ATTN: ELIZABETH  GOLDSTEIN        PHONE NO : 649 574 0100
15 MAURICE PAYKEL PLACE, EAST TAMASE DECISION MADE: 05-FEB-14
AUCKLAND    NZ 2013               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER
CARDIOSOLUTIONS INC               510(k) NO: K140015(SPECIAL)
ATTN: CHRISTINE  SANTAGATE        PHONE NO : 781 344 0801   
375 WEST STREET                   SE DECISION MADE: 05-FEB-14
WEST BRIGEWATER MA 02379          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT
MAINE STANDARDS COMPANY LLC       510(k) NO: K133550(TRADITIONAL)
ATTN: JAMES W CHAMPLIN            PHONE NO : 207 892 1300   
221 US ROUTE 1                    SE DECISION MADE: 05-FEB-14
CUMBERLAND FORESIDE ME 04110      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K133601(TRADITIONAL)
ATTN: PHILIP  LIU                 PHONE NO : 914 524 2443   
511 BENEDICT AVE.                 SE DECISION MADE: 05-FEB-14
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
TERUMO EUROPE N.V.                510(k) NO: K133867(SPECIAL)
ATTN: M.J.  AERTS                 PHONE NO : 321 638 1211
INTERLEUVENLAAN 40                SE DECISION MADE: 05-FEB-14
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
AIR PLASTIC CO., LTD.             510(k) NO: K130890(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 86 108238 7441
ROOM 1606 BLDG. 1 JIANXIANG YUAN NSE DECISION MADE: 06-FEB-14
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALIVECOR HEART MONITOR OTC
ALIVECOR, INC.                    510(k) NO: K130921(TRADITIONAL)
ATTN: MICHAEL  RIGHTER            PHONE NO : 415 795 9812   
30 MAIDEN LANE, 6TH FLOOR         SE DECISION MADE: 06-FEB-14
SAN FRANCISCO CA 94108            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: C-MAX+ (PLUS)
AAT ALBER ANTRIEBSTECHNIK GMBH    510(k) NO: K130864(TRADITIONAL)
ATTN: STEFANIE D BANKSTON         PHONE NO : 409 229 0022   
2611 SHARK CIRCLE                 SE DECISION MADE: 06-FEB-14
TEXAS CITY TX 77591               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRITY SPINAL CARE SYSTEM 3.0
INTEGRITY LIFE SCIENCES           510(k) NO: K130249(TRADITIONAL)
ATTN: JAMES J GIBSON              PHONE NO : 813 933 5500   
2189 WEST BUSCH BLVD              SE DECISION MADE: 06-FEB-14
TAMPA FL 33612                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG WINFUL PLASTIC CO., L510(k) NO: K131341(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 86 10 82387441
ROOM 1606 BLDG 1, JIANXIANG YUAN NSE DECISION MADE: 06-FEB-14
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION
CARESTREAM HEALTH,INC.            510(k) NO: K132824(TRADITIONAL)
ATTN: DAVID C FURR                PHONE NO : 512 906 9654   
8708 CAPEHART COVE                SE DECISION MADE: 06-FEB-14
AUSTIN TX 78733                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DUAL ENERGY SYSTEM PACKAGE
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K132813(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DRIVE               SE DECISION MADE: 06-FEB-14
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUSE 1C COLONOSCOPY SYSTEM
ENDOCHOICE, INC.                  510(k) NO: K132839(TRADITIONAL)
ATTN: DANIEL  HOEFER              PHONE NO : 678 708 4743   
11810 WILLS ROAD                  SE DECISION MADE: 06-FEB-14
ALPHARETTA GA 30009               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STAPIX SUPERELASTIC IMPLANT BONE STAPLES
INSTRATEK, INC.                   510(k) NO: K133523(TRADITIONAL)
ATTN: JEFF  SEAVEY                PHONE NO : 281 890 8020   
15200 Middlebrook Dr Ste G        SE DECISION MADE: 06-FEB-14
Houston TX 77058                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH
APTUS ENDOSYSTEMS, INC.           510(k) NO: K140036(SPECIAL)
ATTN: BURT  GOODSON               PHONE NO : 408 530 9050   
271 GIBRALTAR DRIVE               SE DECISION MADE: 06-FEB-14
SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VDRIVE WITH V-SONO
STEREOTAXIS, INC.                 510(k) NO: K133396(SPECIAL)
ATTN: DIANE  HORWITZ, PH.D. RAC   PHONE NO : 703 307 2921   
4320 FOREST PARK AVENUE SUITE 100 SE DECISION MADE: 06-FEB-14
ST. LOUIS MO 63108                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUVANT MCT SYSTEM
CORVENTIS, INC.                   510(k) NO: K133701(SPECIAL)
ATTN: CHERYL  SWANSON             PHONE NO : 651 762 1824   
1410 ENERGY PARK DRIVE, SUITE 1   SE DECISION MADE: 06-FEB-14
ST. PAUL MN 55108                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRSTRIP REMOTE PATIENT MONITORING
AIRSTRIP TECHNOLOGIES, LP         510(k) NO: K133394(TRADITIONAL)
ATTN: ROBERT A MILLER             PHONE NO : 
335 E. SONTERRA BLVD. SUITE 200   SE DECISION MADE: 06-FEB-14
SAN ANTONIO TX 78258              510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL
FAMIDOC TECHNOLOGY CO., LTD       510(k) NO: K130723(TRADITIONAL)
ATTN: REANNY  WANG                PHONE NO : 86 769892 724888674
No.212 Yilong Road, Hexi IndustriaSE DECISION MADE: 07-FEB-14
Dongguan    CN 523853             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALERTWATCH: OR
ALERTWATCH LLC                    510(k) NO: K130401(TRADITIONAL)
ATTN: DONNA-BEA  TILLMAN          PHONE NO : 410 531 6542   
6594 AUTUMN WIND CIRCLE           SE DECISION MADE: 07-FEB-14
CLARKSVILLE MD 21029              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
HOPE PLASTIC CO., LTD.            510(k) NO: K130807(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 
ROOM 1606 BLDG. 1 JIANXIANG YUAN NSE DECISION MADE: 07-FEB-14
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES
BIOPSYBELL S.R.L.                 510(k) NO: K130616(TRADITIONAL)
ATTN: WILLER  GHELFI              PHONE NO : 973 519 0431   
62 GERDES AVE.                    SE DECISION MADE: 07-FEB-14
VERONA NJ 07004                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NB3D BONE VOID FILLER
PIONEER SURGICAL TECHNOLOGY, INC  510(k) NO: K132050(TRADITIONAL)
ATTN: EMILY  DOWNS                PHONE NO : 906 225 5602   
375 RIVER PARK CIRCLE             SE DECISION MADE: 07-FEB-14
Marquette MI 49855                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM
TWIN STAR MEDICAL, INC.           510(k) NO: K131966(SPECIAL)
ATTN: GREGORY W SACHS             PHONE NO : 612 840 1568   
5116 BIRCH RD.                    SE DECISION MADE: 07-FEB-14
MINNETONKA MN 55345               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RING-LOK MODULAR BIPOLAR SYSTEM
IMPLANTS INTERNATIONAL, LTD       510(k) NO: K132539(TRADITIONAL)
ATTN: TRUDIE  SEEGAR, PHD         PHONE NO : 614 876 6374   
4170 BOWMANSROOT COURT            SE DECISION MADE: 07-FEB-14
HILLIARD OH 43026                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)
PROTEUS DIGITAL HEALTH, INC.      510(k) NO: K133263(SPECIAL)
ATTN: JAFAR  SHENASA              PHONE NO : 650 637 6109   
2600 BRIDGE PARKWAY, SUITE 101    SE DECISION MADE: 07-FEB-14
REDWOOD CITY CA 94065             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECLIPSE TREATMENT PLANNING SYSTEM
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K133247(TRADITIONAL)
ATTN: PETER J CORONADO            PHONE NO : 650 424 6320   
911 HANSEN WAY                    SE DECISION MADE: 07-FEB-14
PALO ALTO CA 94304                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM
HUNTLEIGH HEALTHCARE LIMITED      510(k) NO: K132650(TRADITIONAL)
ATTN: LAURA  GARCIA DEACON        PHONE NO : 442 92 0447703
35 PORTMANMOOR ROAD               SE DECISION MADE: 07-FEB-14
CARDIFF, WALES    UK CF24 5HN     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DUOCENTRIC REVERSED SHOULDER PROSTHESIS
ASTON MEDICAL                     510(k) NO: K133462(TRADITIONAL)
ATTN: CATHERINE  GLOSTER          PHONE NO : 805 679 1258   
577 NORTH HOPE AVE                SE DECISION MADE: 07-FEB-14
SANTA BARBARA CA 93110            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT
HANSEN MEDICAL                    510(k) NO: K133552(SPECIAL)
ATTN: HASSAN  LABAY               PHONE NO : 650 404 5888   
800 EAST MIDDLEFIELD  ROAD        SE DECISION MADE: 07-FEB-14
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTASSIST AND VENASSIST
ACI MEDICAL, LLC                  510(k) NO: K131146(TRADITIONAL)
ATTN: ED  ARKANS                  PHONE NO : 760 744 4400   
1857 DIAMOND ST                   SE DECISION MADE: 10-FEB-14
SAN MARCOS CA 92078               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CITRISOL ACID CONCENTRATE
DIASOL, INC.                      510(k) NO: K130511(TRADITIONAL)
ATTN: MONICA  ABELES              PHONE NO : 818 838 7077   
1110 Arroyo St                    SE DECISION MADE: 10-FEB-14
San Fernando CA 91340             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXXZR(TM)T AND NEXXZR(TM)S
SAGEMAX BIOCERAMICS, INC.         510(k) NO: K130991(TRADITIONAL)
ATTN: JOSE E CABRERA              PHONE NO : 561 339 2815   
34210 9th Ave S Suite 118         SE DECISION MADE: 10-FEB-14
Federal Way WA 98003              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070
INTERVENTIONAL SPINE, INC.        510(k) NO: K133583(SPECIAL)
ATTN: JANE  METCALF               PHONE NO : 949 472 0006   
13700 ALTON PKWY., SUITE 160      SE DECISION MADE: 10-FEB-14
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMRI 1.5T AND IMRI 3T S
IMRIS, INC.                       510(k) NO: K133692(TRADITIONAL)
ATTN: SANJAY  SHAH                PHONE NO : 763 203 6380   
5101 Shady Oak Rd                 SE DECISION MADE: 10-FEB-14
Minnetonka MN 55343               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS
SYNCHRO MEDICAL                   510(k) NO: K133477(TRADITIONAL)
ATTN: MARK F SCHENK               PHONE NO : 610 507 8255   
505 BERKS PLACE                   SE DECISION MADE: 10-FEB-14
WEST LAWN PA 19609                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUILION ONE VISION
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K133497(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DRIVE               SE DECISION MADE: 10-FEB-14
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: C-PLUS
PIONEER SURGICAL TECHNOLOGY, INC  510(k) NO: K133623(TRADITIONAL)
ATTN: SARAH  MCINTYRE             PHONE NO : 906 225 5861   
375 RIVER PARK CIRCLE             SE DECISION MADE: 10-FEB-14
Marquette MI 49855                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EQUINOXE EXTRA SHORT HUMERAL HEAD
EXACTECH, INC.                    510(k) NO: K140063(SPECIAL)
ATTN: PATRICK  HUGHES             PHONE NO : 352 327 4762   
2320 N.W. 66TH CT.                SE DECISION MADE: 11-FEB-14
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD
JUSTRIGHT SURGICAL, LLC           510(k) NO: K132472(TRADITIONAL)
ATTN: MICHELE  LUCEY              PHONE NO : 603 748 1374   
128 BLYE HILL LANDING             SE DECISION MADE: 11-FEB-14
NEWBURY NH 03255                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EZ-IO INTRAOSSEOUS INFUSION SYSTEM
VIDACARE CORPORATION              510(k) NO: K132583(TRADITIONAL)
ATTN: LARRY J MILLER              PHONE NO : 210 375 8500   
4350 LOCKHILL SELMA ROAD          SE DECISION MADE: 11-FEB-14
SHAVANO PARK TX 78249 2095        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK
AMENDIA, INC.                     510(k) NO: K132925(TRADITIONAL)
ATTN: JOHN  KAPITAN               PHONE NO : 704 843 7852   
1755 W. OAK PARKWAY               SE DECISION MADE: 11-FEB-14
MARIETTA GA 30062                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONTROL SEAL
VOCO GMBH                         510(k) NO: K130485(TRADITIONAL)
ATTN: T.  GERKENSMEIER            PHONE NO : 49 4721 719200
ANTON-FLETTNER-STRASSE 1-3        SE DECISION MADE: 11-FEB-14
CUXHAVEN    GM D-27472            510(k) STATEMENT

DEVICE: GUAVA II
CARDIOCOMM SOLUTIONS, INC.        510(k) NO: K122632(TRADITIONAL)
ATTN: JONATHAN  WARD              PHONE NO : 813 645 2855   
445 APOLLO BEACH BLVD.            SE DECISION MADE: 11-FEB-14
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DANA REUSABLE TEST PACK
DANA PRODUCTS, INC.               510(k) NO: K133267(TRADITIONAL)
ATTN: HARRY  BALA                 PHONE NO : 847 455 2881   
7 COREY DR.                       SE DECISION MADE: 11-FEB-14
SOUTH BARRINGTON IL 60010         510(k) STATEMENT

DEVICE: ADHESE UNIVERSAL
IVOCLAR VIVADENT AG               510(k) NO: K133318(TRADITIONAL)
ATTN: DONNA  HARTNETT             PHONE NO : 716 691 2260   
175 PINEVIEW DR.                  SE DECISION MADE: 11-FEB-14
AMHERST NY 14228                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY
ORTHOCON, INC.                    510(k) NO: K140117(SPECIAL)
ATTN: HOWARD L SCHRAYER           PHONE NO : 609 924 9510   
1 BRIDGE STREET, SUITE 121        SE DECISION MADE: 11-FEB-14
IRVINGTON NY 10533                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDORINGS
ENDO-AID, INC.                    510(k) NO: K133359(TRADITIONAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET STREET, 29TH FLOOR    SE DECISION MADE: 11-FEB-14
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: V8 TRANSLUMINAL BAV CATHETER
INTERVALVE, INC                   510(k) NO: K133607(TRADITIONAL)
ATTN: JULIE  BODMER               PHONE NO : 612 910 3412   
8401 73RD AVENUE NORTH, STE 63    SE DECISION MADE: 11-FEB-14
MINNEAPOLIS MN 55428              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEPITEL AG
MOLNLYCKE HEALTH CARE             510(k) NO: K130040(TRADITIONAL)
ATTN: ANGELA L BUNN               PHONE NO : 678 250 7930   
5550 PEACHTREE PARKWAY SUITE 500  SE DECISION MADE: 12-FEB-14
NORCROSS GA 30092                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE LATEX EXAMINATION GLOVES
QUBE MEDICAL PRODUCT SDN BHD      510(k) NO: K123537(TRADITIONAL)
ATTN: TERENCE  LIM                PHONE NO : 603 6034 4710
NO 10, JALAN KPK 1/1, KAWASAN PERISE DECISION MADE: 12-FEB-14
KUNDANG    MY 48020               510(k) STATEMENT

DEVICE: ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET;
ZEVEX, INC.                       510(k) NO: K131154(SPECIAL)
ATTN: NILOUFAR  SAMIMI            PHONE NO : 801 264 1001   
4314 ZEVEX PARK LN.               SE DECISION MADE: 12-FEB-14
Salt Lake City UT 84123           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
DECENT PLASTIC CO., LTD.          510(k) NO: K131033(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 
ROOM 1606 BLG 1 JIANXIANG YUAN NO SE DECISION MADE: 12-FEB-14
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OWL CONTACT LENS CASES, DOG CONTACT LENS CASES
NINGBO LISHUNDA ELECTRONICS CO., L510(k) NO: K130930(TRADITIONAL)
ATTN: CHARLES  SHEN               PHONE NO : 608 217 9358   
5 CAREY STREET                    SE DECISION MADE: 12-FEB-14
PENNINGTON NJ 08534               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWERHEART G5 AED
CARDIAC SCIENCE CORPORATION       510(k) NO: K122758(TRADITIONAL)
ATTN: KATHLEEN  ROBERTS           PHONE NO : 949 797 3844   
N7 W22025 Johnson Dr --           SE DECISION MADE: 12-FEB-14
Waukesha WI 53186                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: C-BOX PEEK CERVICAL IBF
INNOVASIS, INC.                   510(k) NO: K132991(TRADITIONAL)
ATTN: MARSHALL  MCCARTY           PHONE NO : 801 261 2236   
614 EAST 3900 SOUTH               SE DECISION MADE: 12-FEB-14
SALT LAKE CITY UT 84107           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PTFE SURGICAL SUTURE
OMNIA SPA                         510(k) NO: K132464(TRADITIONAL)
ATTN: MARCO  MANDUCHI             PHONE NO : 390 54 2643496
VIA SARAGAT 5                     SE DECISION MADE: 12-FEB-14
IMOLA, BO    IT 40026             510(k) STATEMENT

DEVICE: EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM
EXACTECH, INC.                    510(k) NO: K132582(TRADITIONAL)
ATTN: PATRICK  HUGHES             PHONE NO : 352 327 4762   
2320 N.W. 66TH CT.                SE DECISION MADE: 12-FEB-14
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD
TOTAL JOINT ORTHOPEDICS, INC.     510(k) NO: K131454(TRADITIONAL)
ATTN: JEAN M WHEELER              PHONE NO : 801 486 6070   
1567 E. Stratford Avenue          SE DECISION MADE: 12-FEB-14
Salt Lake City UT 84106           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHASER V-MINI 2 HAIR REMOVAL SYSTEM
SHASER, INC.                      510(k) NO: K133201(TRADITIONAL)
ATTN: ANTHONY  BURNS              PHONE NO : 781 995 2246   
10 MAGUIRE RD BUILDING ONE        SE DECISION MADE: 12-FEB-14
LEXINGTON MA 02421                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: METRIXCARE
THE METRIX COMPANY                510(k) NO: K132424(TRADITIONAL)
ATTN: NICHOLAS  SPECHT            PHONE NO : 563 556 8800   
4400 CHAVENELLE RD.               SE DECISION MADE: 12-FEB-14
DUBUQUE IA 52002 2655             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENA PRO
INNOVAMED HEALTH, LLC             510(k) NO: K133274(TRADITIONAL)
ATTN: JOE  ADKINS                 PHONE NO : 216 849 7847   
2839 HARVEST MOON DRIVE           SE DECISION MADE: 12-FEB-14
ORANGE PARK FL 32073   32073      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONVENTUS DRS
CONVENTUS ORTHOPAEDICS            510(k) NO: K131552(TRADITIONAL)
ATTN: KENT  LIND                  PHONE NO : 763 515 5000   
10200 73RD AVENUE NORTH STE 122   SE DECISION MADE: 12-FEB-14
MAPLE GROVE MN 55369              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K132720(TRADITIONAL)
ATTN: ALINA  STUBBS               PHONE NO : 610 651 5000   
65 GREAT VALLEY PAKRWAY           SE DECISION MADE: 12-FEB-14
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 15 FR. TANDEMHEART ARTERIAL CANNULA
CARDIACASSIST INC.                510(k) NO: K133293(SPECIAL)
ATTN: GREG  JOHNSON               PHONE NO : 412 963 7770   
240 ALPHA DRIVE                   SE DECISION MADE: 12-FEB-14
PITTSBURGH PA 15238               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GEODESICEEG SYSTEM 400 SERIES (GES 400)
ELECTRICAL GEODESICS, INC.        510(k) NO: K131882(TRADITIONAL)
ATTN: LINDA J BOVARD              PHONE NO : 541 345 5431   
29611 SIMMONS ROAD                SE DECISION MADE: 12-FEB-14
EUGENE OR 97405                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGER MEDICAL ESU-110
LIGER MEDICAL, LLC                510(k) NO: K133273(TRADITIONAL)
ATTN: STEVE  SMITH                PHONE NO : 801 532 0221   
825 N 300 WEST #NE127             SE DECISION MADE: 12-FEB-14
SALT LAKE CITY UT 84103           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYPERSOUND AUDIO SYSTEM (HSS)
HYPERSOUND HEALTH, INC.           510(k) NO: K133352(TRADITIONAL)
ATTN: JAMES A BARNES              PHONE NO : 888 496 8001   
13771 DANIELSON ST. STE. L        SE DECISION MADE: 12-FEB-14
POWAY CA 92064   92064            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHYSIOFLOW Q-LINK
VASOCOM, INC.                     510(k) NO: K140102(SPECIAL)
ATTN: JAMES  GUNNERSON            PHONE NO : 215 826 9998   
2014 FORD RD., UNIT G             SE DECISION MADE: 12-FEB-14
BRISTOL PA 19007                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESTORELLE Y CONTOUR MESH
COLOPLAST A/S                     510(k) NO: K140116(SPECIAL)
ATTN: TIM  CRABTREE               PHONE NO : 612 302 4922   
1601 WEST RIVER ROAD N            SE DECISION MADE: 12-FEB-14
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION
CARL ZEISS MEDITEC AG             510(k) NO: K133476(TRADITIONAL)
ATTN: SARAH  HARRINGTON           PHONE NO : 925 560 5134   
5160 HACIENDA DRIVE               SE DECISION MADE: 12-FEB-14
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MDIXON-QUANT
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K133526(TRADITIONAL)
ATTN: SUSAN  QUICK                PHONE NO : 440 483 2291   
595 MINER RD.                     SE DECISION MADE: 12-FEB-14
CLEVLAND OH 44143                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOGIQ E
GE HEALTHCARE                     510(k) NO: K133533(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 INNOVATION DRIVE             SE DECISION MADE: 12-FEB-14
WAUWATOSA WI 53233                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRODUCER SETS, MODEL ADELANTE RADIAL
OSCOR INC.                        510(k) NO: K130633(TRADITIONAL)
ATTN: MILA  DOSKOCIL              PHONE NO : 727 937 2511   
3816 DE SOTO BLVD.                SE DECISION MADE: 13-FEB-14
PALM HARBOR FL 34683              510(k) STATEMENT

DEVICE: MANUAL WHEELCHAIR
ZHEJIANG JIAFENG ELECTRICAL & MECH510(k) NO: K132257(TRADITIONAL)
ATTN: CHARLES  SHEN               PHONE NO : 608 217 9358   
5 CAREY STREET                    SE DECISION MADE: 13-FEB-14
PENNINGTON NJ 08534               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PALS PLATINUM NEUROSTIMULATION ELECTRODES
AXELGAARD MFG. CO., LTD.          510(k) NO: K132422(TRADITIONAL)
ATTN: DAN P JEFFERY               PHONE NO : 760 451 8000   
520 INDUSTRIAL WAY                SE DECISION MADE: 13-FEB-14
FALLBROOK CA 92028 2244           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACTIVAPATCH ET IONTOPHORESIS PATCH
ACTIVATEK INC.                    510(k) NO: K132832(TRADITIONAL)
ATTN: JAMAL  YANAKI               PHONE NO : 800 680 5520   
2734 S. 3600 WEST UNIT F          SE DECISION MADE: 13-FEB-14
WEST VALLEY CITY UT 84119         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARRICADE EMBOLIZATION COIL SYSTEM
BLOCKADE MEDICAL                  510(k) NO: K140104(SPECIAL)
ATTN: REBECCA K PINE              PHONE NO : 760 809 5178   
18 Technology Dr Ste 169          SE DECISION MADE: 13-FEB-14
Irvine CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TREZ_HD
EXCEL-TECH LTD. (XLTEK)           510(k) NO: K131266(TRADITIONAL)
ATTN: DANIEL  RAMIREZ             PHONE NO : 905 829 5300
2568 BRISTOL CIR.                 SE DECISION MADE: 14-FEB-14
OAKVILLE, ONTARIO    CA L6H 5S1   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR
BRACCO DIAGNOSTIC, INC.           510(k) NO: K132192(TRADITIONAL)
ATTN: TRACEY  ALEXANDER           PHONE NO : 609 524 2865   
259 PROSPECT PLAINS ROAD BUILDING SE DECISION MADE: 14-FEB-14
MONROE TOWNSHIP NJ 08831          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWERPORT IMPLANTABLE PORT
C.R. BARD, INC.                   510(k) NO: K133335(TRADITIONAL)
ATTN: AMY  HONEY                  PHONE NO : 801 522 5671   
605 N 5600 W                      SE DECISION MADE: 14-FEB-14
SALT LAKE CITY UT 84116           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL
HAGER & MEISINGER GMBH            510(k) NO: K132212(TRADITIONAL)
ATTN: WIEBKE  STOLTEN             PHONE NO : 49 213120 12388
HANSEMANNSTRASSE 10               SE DECISION MADE: 14-FEB-14
NEUSS    GM D-41468               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STELLARIS VISION ENHANCEMENT SYSTEM
BAUSCH & LOMB                     510(k) NO: K133242(SPECIAL)
ATTN: TIMOTHY W CAPEHART          PHONE NO : 636 226 3017   
3365 TREE COURT INDUSTRIAL BLV    SE DECISION MADE: 14-FEB-14
ST LOUIS MO 63122                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS
SYLPHAR N.V.                      510(k) NO: K132426(TRADITIONAL)
ATTN: ROGER  GRAY                 PHONE NO : 39 06 5782665
PIAZZA ALBANIA 10                 SE DECISION MADE: 14-FEB-14
ROME, ITALY    IT 00153           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVEAL LINQ INSERTABLE CARDIAC MONITOR
MEDTRONIC INC.                    510(k) NO: K132649(TRADITIONAL)
ATTN: ERIC  KALMES                PHONE NO : 763 526 2809   
8200 CORAL SEA STREET NE          SE DECISION MADE: 14-FEB-14
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XCATH
ALSEAL                            510(k) NO: K133296(TRADITIONAL)
ATTN: YOLANDA  SMITH              PHONE NO : 888 729 9674   
1468 HARWELL AVENUE               SE DECISION MADE: 14-FEB-14
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VICTUS FEMTOSECOND LASER PLATFORM
TECHNOLAS PERFECT VISION GMBH     510(k) NO: K132534(TRADITIONAL)
ATTN: KEN  NEHMER                 PHONE NO : 415 297 0408   
1025 SANCHEZ STREET               SE DECISION MADE: 14-FEB-14
SAN FRANCISCO CA 94114            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANGIOJET ULTRA AVX THROMBECTOMY SET
POSSIS MEDICAL, INC.              510(k) NO: K133629(SPECIAL)
ATTN: GEORGE  LUCAS               PHONE NO : 763 780 4555   
9055 EVERGREEN BLVD., N.W.        SE DECISION MADE: 14-FEB-14
MINNEAPOLIS MN 55433 8003         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3MP GRAYSCAKE LCD DISPLAY
SHENZHEN BEACON DISPLAY TECHNOLOGY510(k) NO: K140103(TRADITIONAL)
ATTN: WU  QIN                     PHONE NO : 867 552699 5355
RM 201, INCUBATOR BUILDING, CASTD,SE DECISION MADE: 14-FEB-14
SHENZHEN, GUANGDONG    CH 518057  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3MP COLOR LCD DISPLAY
SHENZHEN BEACON DISPLAY TECHNOLOGY510(k) NO: K140108(TRADITIONAL)
ATTN: WU  QIN                     PHONE NO : 86 755269 95355
RM 201, INCUBATOR BUILDING, CASTD,SE DECISION MADE: 14-FEB-14
SHENZHEN, GUANGDONG    CH 518057  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: L.A.M. IPM WOUND GEL, IPM DERM GEL
GLYCOBIOSCIENCES, INC             510(k) NO: K130781(TRADITIONAL)
ATTN: OLUFEMI  ADEOYE             PHONE NO : 905 271 2709 X 225
181 LAKESHORE ROAD EAST           SE DECISION MADE: 14-FEB-14
MISSISSAUGA, ONTARIO    CA L5G 1G2510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE
CELLCO PARTNERSHIP D/B/A VERIZON W510(k) NO: K134004(TRADITIONAL)
ATTN: LOLITA D FORBES             PHONE NO : 202 515 2454   
ONE VERIZON WAY                   SE DECISION MADE: 14-FEB-14
BASKING RIDGE NJ 07920            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE
NIPRO MEDICAL CORPORATION         510(k) NO: K140136(SPECIAL)
ATTN: JESSICA  OSWALD-MCLEOD      PHONE NO : 305 599 7174   
3150 N.W. 107TH AVE.              SE DECISION MADE: 14-FEB-14
DORAL FL 33172                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MD302C4 29.8" DIAGNOSTIC IMAGING LCD MONITOR
NEC DISPLAY SOLUTIONS, LTD.       510(k) NO: K133708(TRADITIONAL)
ATTN: TONY  HSU                   PHONE NO : 886 22603 7288
1F, NO. 181, SEC. 2 WUNHUA 1ST ROASE DECISION MADE: 14-FEB-14
NEW TAIPEI CITY    TW 24457       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRSTRIP REMOTE PATIENT MONITORING
AIRSTRIP TECHNOLOGIES, LP         510(k) NO: K133450(SPECIAL)
ATTN: ROBERT A MILLER             PHONE NO : 210 363 8753   
335 E. SONTERRA BLVD. SUITE 200   SE DECISION MADE: 14-FEB-14
SAN ANTONIO TX 78258              510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES
FRIEND PLASTIC CO., LTD.          510(k) NO: K130891(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 
ROOM 1606 BLDG. 1 JIANXIANG YUAN NSE DECISION MADE: 18-FEB-14
BEIJING    CH 050000              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
JEWEL PLASTIC CO., LTD.           510(k) NO: K130809(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 86 10 82387441
ROOM 1606 BLDG. 1 JIANXIANG YUAN NSE DECISION MADE: 18-FEB-14
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
KAIXUAN PLASTIC CO., LTD.         510(k) NO: K130800(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 86 108238 7441
RM.1606 BLDG.1 JIANXIANG YUAN NO.2SE DECISION MADE: 18-FEB-14
HAIDIAN DISTRICT, BEIJING    CH 10510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: A SERIES AND Q SERIES PATIENT MONITORS
GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K131898(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 120-119                  SE DECISION MADE: 18-FEB-14
SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SARNS SOFT-FLOW AORTIC CANNULA
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K132451(TRADITIONAL)
ATTN: GARRY A COURTNEY            PHONE NO : 800 262 3304   
125 BLUE BALL RD.                 SE DECISION MADE: 18-FEB-14
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDOS HILITE OXYGENATOR
MEDOS MEDIZINTECHNIK AG           510(k) NO: K140177(SPECIAL)
ATTN: LEANN  CHRISTMAN            PHONE NO : 734 995 9089   
3526 WEST LIBERTY RD.             SE DECISION MADE: 18-FEB-14
ANN ARBOR MI 48103   48103        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TIDISHEILD
TIDI PRODUCTS, LLC                510(k) NO: K132953(TRADITIONAL)
ATTN: DION  BRANDT                PHONE NO : 920 751 4386   
570 ENTERPRISE DR.                SE DECISION MADE: 18-FEB-14
NEENAH WI 54956                   510(k) STATEMENT

DEVICE: KASM KNEE ARTICULATING SPACER MOLDS
ORTHO DEVELOPMENT CORP.           510(k) NO: K133449(TRADITIONAL)
ATTN: MIKE  ENSIGN                PHONE NO : 801 553 9991   
12187 SOUTH BUSINESS PARK DR.     SE DECISION MADE: 18-FEB-14
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDICINAL LEECHES
BIOPHARM (UK) LTD.                510(k) NO: K132958(TRADITIONAL)
ATTN: BETHANY  SAWYER             PHONE NO : 44 1792 885595
2 BRYNGWILI ROAD                  SE DECISION MADE: 19-FEB-14
HENDY    UK SA4 0XT               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RS-3000 ADVANCE
NIDEK CO., LTD.                   510(k) NO: K132323(TRADITIONAL)
ATTN: LENA  SATTLER               PHONE NO : 440 554 3706   
1667 RIDGEWOOD RD                 SE DECISION MADE: 19-FEB-14
WADSWORTH OH 44281                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE
CARDICA, INC.                     510(k) NO: K140170(SPECIAL)
ATTN: VEE  ARYA                   PHONE NO : 650 644 7339   
900 SAGINAW DR.                   SE DECISION MADE: 19-FEB-14
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDOS HILITE INFANT OXYGENATOR
MEDOS MEDIZINTECHNIK AG           510(k) NO: K140181(SPECIAL)
ATTN: LEANN  CHRISTMAN            PHONE NO : 734 995 9089   
3526 WEST LIBERTY RD.             SE DECISION MADE: 19-FEB-14
ANN ARBOR MI 48103   48103        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO NAUTILUS SPINAL SYSTEM
LIFE SPINE, LLC.                  510(k) NO: K133564(SPECIAL)
ATTN: RANDY  LEWIS                PHONE NO : 847 884 6117   
2401 W. HASSELL RD. SUITE 1535    SE DECISION MADE: 19-FEB-14
HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K140030(TRADITIONAL)
ATTN: TAN  ZHIFENG                PHONE NO : 86 75581 885334
BLDG. 9-13 BAIWANGXIN HIGH-TEC INDSE DECISION MADE: 19-FEB-14
SHENZHEN, NAHSHAN    CH 518108    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 30.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6)
JVC KENWOOD CORPORATION           510(k) NO: K140214(TRADITIONAL)
ATTN: TSUKASA  TASHIRO            PHONE NO : 81 258 246611
3-12 MORIYA-CHO, KANAGAWA-KU      SE DECISION MADE: 19-FEB-14
YOKOHAMA-SHI, KANAGAWA    JA 221-0510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 8MM TROCAR KIT
INTUITIVE SURGICAL                510(k) NO: K133845(TRADITIONAL)
ATTN: BRANDON  HANSEN             PHONE NO : 408 523 7485   
1266 KIFER ROAD                   SE DECISION MADE: 19-FEB-14
SUNNYVALE CA 94086                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFANT PHOTOTHERAPY BILITRON SKY 5006
FANEM LDA                         510(k) NO: K131196(TRADITIONAL)
ATTN: TARA  CONRAD                PHONE NO : 305 377 0077   
18851 NE 29TH AVE 720             SE DECISION MADE: 20-FEB-14
AVENTURA FL 33180                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANCED PERFUSION SYSTEM 1
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K131041(TRADITIONAL)
ATTN: MARK  BUR                   PHONE NO : 734 663 4145   
6200 JACKSON RD.                  SE DECISION MADE: 20-FEB-14
ANN ARBOR MI 48103                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JMS SYRINGE
JMS NORTH AMERICA CORPORATION     510(k) NO: K132321(TRADITIONAL)
ATTN: SHO  HOSOKI                 PHONE NO : 510 888 9090   
22320 FOOTHILL BLVD SUITE 350     SE DECISION MADE: 20-FEB-14
HAYWARD CA 94541                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
NEOMETRICS, INC.                  510(k) NO: K133076(TRADITIONAL)
ATTN: DAVID  LIEBL                PHONE NO : 763 559 4440   
2605 FERNBROOK LANE N. SUITE J    SE DECISION MADE: 20-FEB-14
PLYMOUTH MN 55447                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RELIEVA SCOUT SINUS DILATION SYSTEM
ACCLARENT, INC.                   510(k) NO: K140160(SPECIAL)
ATTN: JAMES P GARVEY, II          PHONE NO : 650 687 4807   
1525-B O'BRIEN DR.                SE DECISION MADE: 20-FEB-14
MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROINSERT
NIDACON INTERNATIONAL AB          510(k) NO: K131145(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 20-FEB-14
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
GLOBUS MEDICAL INC.               510(k) NO: K133567(SPECIAL)
ATTN: CHRISTINA  KICHULA          PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 20-FEB-14
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JAZZ SYSTEM
IMPLANET S.A.                     510(k) NO: K133617(TRADITIONAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET ST. 29TH FLOOR        SE DECISION MADE: 20-FEB-14
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INBONE TOTAL ANKLE
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K133585(SPECIAL)
ATTN: VAL  MYLES                  PHONE NO : 901 290 5162   
5677 AIRLINE RD.                  SE DECISION MADE: 20-FEB-14
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PELLEFIRM
ELLMAN INTERNATIONAL, INC.        510(k) NO: K132949(TRADITIONAL)
ATTN: ALISON  SATHE               PHONE NO : 516 594 3333   
400 KARIN LANE                    SE DECISION MADE: 20-FEB-14
HICKSVILLE NY 11801               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CANTATA(R) 2.9 MICROCATHETER
COOK, INC.                        510(k) NO: K131772(TRADITIONAL)
ATTN: JENNIFER A RICHARDSON       PHONE NO : 812 339 2235   
750 DANIELS WAY                   SE DECISION MADE: 20-FEB-14
BLOOMINGTON IN 47402 0489         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXIOM REG
ANTHOGYR SAS                      510(k) NO: K131066(TRADITIONAL)
ATTN: THERESE  CANDAU             PHONE NO : 330 450580 237
2237, AVENUE ANDRE LASQUIN        SE DECISION MADE: 21-FEB-14
SALLANCHES    FR 74700            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDLINE BIOPSY VALVE
MEDLINE INDUSTRIES, INC.          510(k) NO: K131426(TRADITIONAL)
ATTN: MATT  CLAUSEN               PHONE NO : 847 643 4785   
ONE MEDLINE PLACE                 SE DECISION MADE: 21-FEB-14
MUNDELEIN IL 60060                510(k) STATEMENT

DEVICE: LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM
NUCLETRON B.V.                    510(k) NO: K132874(SPECIAL)
ATTN: RUDOLF  VOS                 PHONE NO : 31 318 557133
WAARDGELDER 1                     SE DECISION MADE: 21-FEB-14
VEENENDAAL    NL 3905 TH          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN,
STRAUMANN USA, LLC                510(k) NO: K132219(TRADITIONAL)
ATTN: JENNIFER M JACKSON          PHONE NO : 978 747 2509   
60 MINUTEMAN ROAD                 SE DECISION MADE: 21-FEB-14
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEME
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132935(TRADITIONAL)
ATTN: CHRISTINE  DUNBAR           PHONE NO : 925 293 5442   
757 A ARNOLD DRIVE                SE DECISION MADE: 21-FEB-14
MARTINEZ CA 94553                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMNI PATENT MONITORS
INFINIUM MEDICAL                  510(k) NO: K132229(TRADITIONAL)
ATTN: JOHN  O'BRIEN               PHONE NO : 813 645 2855   
445 APOLLO BEACH BLVD             SE DECISION MADE: 21-FEB-14
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM
NONIN MEDICAL, INC.               510(k) NO: K132402(TRADITIONAL)
ATTN: BRODIE  PEDERSEN            PHONE NO : 763 577 3180   
13700 1ST AVE. NORTH              SE DECISION MADE: 21-FEB-14
PLYMOUTH MN 55441 5443            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER
BIOCARE ASIA CORPORATION LTD.     510(k) NO: K132457(TRADITIONAL)
ATTN: SHUCHI  CHANG               PHONE NO : 86 512 68097762
NO. 260, MAYUN ROAD               SE DECISION MADE: 21-FEB-14
NEW DISTRICT SUZHOU    CH 215129  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLAATZ 600 SERIES (FLAATZ 600/601)
DRTECH CORP.                      510(k) NO: K132842(SPECIAL)
ATTN: CHOUL-WOO  SHIN             PHONE NO : 82 31 7848856
333-1, SANGDAEWON1-DONG JUNGWON-GUSE DECISION MADE: 21-FEB-14
SEONGNAM-SHI, GYEONGGI-DO    KS 46510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREEDOM PCK COMPONENTS
MAXX ORTHOPEDICS, INC.            510(k) NO: K131481(TRADITIONAL)
ATTN: NACH  DAVE                  PHONE NO : 732 718 1385   
531 PLYMOUTH RD., SUITE 526       SE DECISION MADE: 21-FEB-14
PLYMOUTH MEETING PA 19462         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: T-TYPE D-KAT, R-TYPE D-KAT
KEELER LIMITED                    510(k) NO: K133234(TRADITIONAL)
ATTN: EUGENE R VANARSDALE         PHONE NO : 610 353 4350   
456 PARKWAY                       SE DECISION MADE: 21-FEB-14
BROOMALL PA 19008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OXYGEN GENERATOR LIQUEFIER - (OGL)
ESSEX CRYOGENICS OF MISSOURI, INC.510(k) NO: K131990(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
8007 CHIVVIS DR.                  SE DECISION MADE: 21-FEB-14
ST. LOUIS MO 63123                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM
JEDMED INSTRUMENT CO.             510(k) NO: K132039(TRADITIONAL)
ATTN: CRAIG  PARKS                PHONE NO : 314 845 3770   
5416 JEDMED CT.                   SE DECISION MADE: 21-FEB-14
ST. LOUIS MO 63129 2221           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLAROID CONTACTSPOD
VIOPTI LTD                        510(k) NO: K131783(TRADITIONAL)
ATTN: EDWIN  LINDSAY              PHONE NO : 004 40791 7134922
POLAROID BLDG, VALE OF LEVEN INDUSSE DECISION MADE: 21-FEB-14
DUMBARTON    UK G82 3PW           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVOHIP TOTAL HIP SYSTEM
NOVOSOURCE INC                    510(k) NO: K132158(TRADITIONAL)
ATTN: SHARON  KVISTAD             PHONE NO : 317 228 8715   
714 E. MONUMENT AVE. STE 219      SE DECISION MADE: 21-FEB-14
DAYTON OH 45402                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONITOR B40
GE MEDICAL SYSTEMS CHINA CO., LTD.510(k) NO: K133576(SPECIAL)
ATTN: ROBERT  CASARSA             PHONE NO : 414 362 3063   
8200 WEST TOWER AVE               SE DECISION MADE: 21-FEB-14
MILWAUKEE WI 53223                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT
BARD PERIPHERAL VASCULAR, INC.    510(k) NO: K133948(SPECIAL)
ATTN: SARAH  MCCARTNEY            PHONE NO : 480 638 2954   
1625 WEST 3RD ST.                 SE DECISION MADE: 21-FEB-14
TEMPE AZ 85281                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CENTAUR TESTOSTERONE (TSTO)
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K133491(TRADITIONAL)
ATTN: MATTHEW  GEE                PHONE NO : 914 524 2099   
511 BENEDICT AVENUE               SE DECISION MADE: 21-FEB-14
TARRYTOWN NY 10591 5097           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA
RAYENCE CO., LTD                  510(k) NO: K133409(SPECIAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
8310 BUFFALO SPEEDWAY             SE DECISION MADE: 21-FEB-14
HOUSTON TX 77025                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHERPA PAK CARDIAC TRANSPORT SYSTEM
PARAGONIX TECHNOLOGIES, INC.      510(k) NO: K133432(TRADITIONAL)
ATTN: LEO  BASTA                  PHONE NO : 617 834 9866   
93 BENEFIT STREET                 SE DECISION MADE: 21-FEB-14
PROVIDENCE RI 02904               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS
LIN-ZHI INTERNATIONAL, INC.       510(k) NO: K133710(TRADITIONAL)
ATTN: BERNICE  LIN                PHONE NO : 408 732 3856   
670 Almanor Ave                   SE DECISION MADE: 21-FEB-14
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM
COVIDIEN                          510(k) NO: K131252(TRADITIONAL)
ATTN: MICHAEL  AYMAMI             PHONE NO : 303 305 2481   
6135 GUNBARREL AVE.               SE DECISION MADE: 24-FEB-14
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MATRICEL DENTAL BARRIER MEMBRANE
MATRICEL GMBH                     510(k) NO: K123697(TRADITIONAL)
ATTN: DR. INGO  HESCHEL           PHONE NO : 492 407564 411
KAISERSTRABE 100                  SE DECISION MADE: 24-FEB-14
HERZOGENRATH    GM 52134          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DALTON LIFT CHAIR
DALTON INSTRUMENT CORP.           510(k) NO: K131909(TRADITIONAL)
ATTN: MEI  LEIN                   PHONE NO : 469 522 1200   
16300 Addison Rd Ste 120          SE DECISION MADE: 24-FEB-14
Addison TX 75001                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIR-FLOW HANDY 3.0 PERIO
E.M.S. ELECTRO MEDICAL SYSTEMS S.A510(k) NO: K132480(TRADITIONAL)
ATTN: CYNTHIA J NOLTE             PHONE NO : 919 859 4207   
62 FOREST ST., STE 300            SE DECISION MADE: 24-FEB-14
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEODENT IMPLANT SYSTEM
JJ INDUSTRIA E COMERCIO DE MATERIA510(k) NO: K133510(TRADITIONAL)
ATTN: KEVIN A THOMAS              PHONE NO : 858 792 1235   
11264 EL CAMINO REAL, SUITE 400   SE DECISION MADE: 24-FEB-14
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &
CODMAN & SHURTLEFF, INC.          510(k) NO: K133625(SPECIAL)
ATTN: HANNAH  FOLEY               PHONE NO : 305 265 6810   
325 PARAMOUNT DR.                 SE DECISION MADE: 24-FEB-14
RAYNHAM MA 02767 0350             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXTRIMILOCK ANKLE PLATING SYSTEM
OSTEOMED LP                       510(k) NO: K133691(TRADITIONAL)
ATTN: BLESSON  ABRAHAM            PHONE NO : 972 677 4600   
3885 Arapaho Rd                   SE DECISION MADE: 24-FEB-14
ADDISON TX 75001                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER
WELL LEAD MEDICAL CO. LTD         510(k) NO: K133615(TRADITIONAL)
ATTN: JOHN  OBRIEN                PHONE NO : 813 645 2855   
445 APOLLO BEACH BLVD.            SE DECISION MADE: 24-FEB-14
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
CELONOVA  BIOSCIENCES, INC.       510(k) NO: K133447(TRADITIONAL)
ATTN: NICOLE  BARBER              PHONE NO : 210 497 6682   
18615 TUSCANY STONE SUITE 100     SE DECISION MADE: 24-FEB-14
SAN ANTONIO TX 78258              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RETRACTION PASTE
DMG USA, INC.                     510(k) NO: K130580(TRADITIONAL)
ATTN: PAMELA  PAPINEAU, RAC       PHONE NO : 978 772 3552   
5 WHITCOMB AVE.                   SE DECISION MADE: 25-FEB-14
AYER MA 01432                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EZ TRANSPORT CHAIR
HARRIS MEDICAL, LLC               510(k) NO: K130517(TRADITIONAL)
ATTN: JAMES  WASON, PH.D.         PHONE NO : 603 672 4678   
7 VILLAGE WOODS DR                SE DECISION MADE: 25-FEB-14
AMHERST NH 03031                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED
DANIEL & DANIEL CONSULTING        510(k) NO: K132389(TRADITIONAL)
ATTN: MICHAEL A DANIEL            PHONE NO : 415 407 0223   
8 SNOWBERRY COURT                 SE DECISION MADE: 25-FEB-14
ORINDA CA 94563                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSULIN PEN NEEDLE
WENZHOU WUZHOU IMPORT & EXPORT CO.510(k) NO: K133058(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 120-119                  SE DECISION MADE: 25-FEB-14
SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSULIN PEN NEEDLE
WENZHOU BEIPU SCIENCE & TECHNOLOGY510(k) NO: K133059(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 120-119                  SE DECISION MADE: 25-FEB-14
SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UP600 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM
QISDA CORPORATION                 510(k) NO: K132690(TRADITIONAL)
ATTN: BOB  LEIKER                 PHONE NO : 925 556 1302   
7263 CRONIN CIRCLE                SE DECISION MADE: 25-FEB-14
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMILEBOND SYSTEM
MILLENNIUM COMPANY LLC            510(k) NO: K132599(TRADITIONAL)
ATTN: STEPHEN J GOLDNER, JD, RAC  PHONE NO : 248 712 0356   
40701 WOODWARD AVE, STE 102       SE DECISION MADE: 25-FEB-14
BLOOMFIELD HILLS MI 48302         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E-Z CHECK OZONE TEST STRIPS
REPROCESSING PRODUCTS CORPORATION 510(k) NO: K132344(TRADITIONAL)
ATTN: MICHAEL  HONSTEIN           PHONE NO : 520 888 5551   
1643 W. MODERN COURT              SE DECISION MADE: 25-FEB-14
TUCSON AZ 85705                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CISNAP CLOSED INCISION SYSTEM
SPIRACUR, INC.                    510(k) NO: K133137(TRADITIONAL)
ATTN: LORI E ADELS, PH.D.         PHONE NO : 408 400 0856   
755 N. MATHILDA AVENUE SUITE 100  SE DECISION MADE: 25-FEB-14
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRESSON SPINAL FIXATION SYSTEM
NEXUS SPINE, LLC                  510(k) NO: K133287(TRADITIONAL)
ATTN: CHRIS  HARMSTON             PHONE NO : 801 742 8342   
2825 EAST COTTONWOOD PKWY.        SE DECISION MADE: 25-FEB-14
SALT LAKE CITY UT 84121           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SFI-BAR IMPLANT ABUTMENTS
STERNGOLD DENTAL LLC              510(k) NO: K132814(ABBREVIATED)
ATTN: MARIA  RAO                  PHONE NO : 508 226 5660   
23 FRANK MOSSBERG DRIVE           SE DECISION MADE: 25-FEB-14
ATTLEBORO MA 02703 0967           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFIED HD GUIDE CATHETER
CONCENTRIC MEDICAL, INC.          510(k) NO: K133177(TRADITIONAL)
ATTN: RHODA  SANTOS               PHONE NO : 510 413 2269   
301 EAST EVELYN AVENUE            SE DECISION MADE: 25-FEB-14
MOUNTAIN VIEW CA 94041   94041    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SICAT FUNCTION
SICAT GMBH & CO. KG               510(k) NO: K133320(TRADITIONAL)
ATTN: MANFRED  BREUER             PHONE NO : 49 228 85469782
BRUNNENALLEE 6                    SE DECISION MADE: 25-FEB-14
BONN    GM D-53177                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SE-601 SERIES ELECTROCARDIOGRAPH
EDAN INSTRUMENTS, INC.            510(k) NO: K131503(TRADITIONAL)
ATTN: CHERRY  SUN                 PHONE NO : 86 755268 56469
NANHAI ROAD 1019# NANSHEN         SE DECISION MADE: 25-FEB-14
SHENZHEN, GUANGDONG    CH 518067  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA
MATERIALISE N.V.                  510(k) NO: K133162(TRADITIONAL)
ATTN: OLIVER  CLEMENS             PHONE NO : 321 67 44537
TECHNOLOGIELAAN 15                SE DECISION MADE: 25-FEB-14
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE
CARDICA, INC.                     510(k) NO: K140118(SPECIAL)
ATTN: VEE  ARYA                   PHONE NO : 650 644 7339   
900 SAGINAW DR.                   SE DECISION MADE: 25-FEB-14
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON SPINAL SYSTEM GROWTH ROD SET
MEDTRONIC SOFAMOR DANEK USA       510(k) NO: K133904(TRADITIONAL)
ATTN: LEE  GRANT                  PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 25-FEB-14
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO.VIA MI WORKFLOWS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133644(TRADITIONAL)
ATTN: ALAINE  MEDIO, RAC          PHONE NO : 865 218 2703   
810 INNOVATION DR.                SE DECISION MADE: 25-FEB-14
KNOXVILLE TN 37932                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEADLINER CS LEAD DELIVERY SYSTEM
VASCULAR SOLUTIONS, INC.          510(k) NO: K133501(TRADITIONAL)
ATTN: MIA  HUNT                   PHONE NO : 763 656 4300   
6464 SYCAMORE COURT NORTH         SE DECISION MADE: 25-FEB-14
MINNEAPOLIS MN 55369              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEODENT IMPLANT SYSTEM
JJGC INDUSTRIA E COMERCIO DE MATER510(k) NO: K133696(TRADITIONAL)
ATTN: KEVIN A THOMAS              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 25-FEB-14
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTONEMV
INCONTROL MEDICAL, LLC            510(k) NO: K134020(TRADITIONAL)
ATTN: JESSICA  ANDRESHAK          PHONE NO : 262 373 0422   
3225 GATEWAY ROAD, SUITE 250      SE DECISION MADE: 25-FEB-14
BROOKFIELD WI 53045               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRINIAS
SHIMADZU CORP.                    510(k) NO: K123508(ABBREVIATED)
ATTN: YOSHIHIRO  MUKUTA           PHONE NO : 075 823 1305
1,NISHINOKYO-KUWABARACHO, NAKAGYOKSE DECISION MADE: 26-FEB-14
KYOTO CITY    JA 604-8511         510(k) STATEMENT

DEVICE: U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL
U&U MEDICAL TECHNOLOGY CO., LTD   510(k) NO: K123162(TRADITIONAL)
ATTN: GARFIELD  WANG              PHONE NO : 861 356 4751751
DONGZHOU VILLAGE, HENGSHANQIAO    SE DECISION MADE: 26-FEB-14
CHANGZHOU    CH 213119            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSI Q SYSTEM ARTHROSCOPES
ORTHOPEDIC SCIENCES, INC          510(k) NO: K133018(TRADITIONAL)
ATTN: KEVIN A THOMAS              PHONE NO : 858 792 1235   
12264 EI CAMINO REAL SUITE 400    SE DECISION MADE: 26-FEB-14
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRESSURE CONNECTING TUBE
SHENZHEN ANT HI-TECH INDUSTRIAL CO510(k) NO: K131770(TRADITIONAL)
ATTN: LYNN  FU                    PHONE NO : 86 755 26903311
46 Keji Ave.,Yuquan Industrial ParSE DECISION MADE: 26-FEB-14
Dongguan    CN 523696             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANAL RECTAL OVERTUBE
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K131598(TRADITIONAL)
ATTN: ERIC  MAYNARD               PHONE NO : 440 639 4494   
5976 HEISLEY RD.                  SE DECISION MADE: 26-FEB-14
MENTOR OH 44060                   510(k) STATEMENT

DEVICE: EXCELERON BACTERIAL FILTERS
EXCELERON MEDICAL                 510(k) NO: K131626(TRADITIONAL)
ATTN: BERNARD  HORWATH            PHONE NO : 651 231 1761   
4486 TIMBERLINE CT                SE DECISION MADE: 26-FEB-14
VADNAIS HEIGHTS MN 55127          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHROSURFACE TOEMOTION
ARTHROSURFACE, INC.               510(k) NO: K132496(TRADITIONAL)
ATTN: DAWN J WILSON               PHONE NO : 508 520 3003   
28 FORGE PARKWAY                  SE DECISION MADE: 26-FEB-14
FRANKLIN MA 02038                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)
NUCLETRON B.V.                    510(k) NO: K132889(TRADITIONAL)
ATTN: RUDOLF  VOS                 PHONE NO : 31 318 557133
WAARDGELDER 1                     SE DECISION MADE: 26-FEB-14
VEENENDAAL    NL 3905 TH          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUREFIRE GUIDING CATHETER
SUREFIRE MEDICAL, INC.            510(k) NO: K140034(TRADITIONAL)
ATTN: LYNNE  ARONSON              PHONE NO : 720 305 9877   
8601 TURNPIKE DR. STE 206         SE DECISION MADE: 26-FEB-14
WESTMINSTER CO 80031              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EZONO 4000
EZONO AG                          510(k) NO: K140254(TRADITIONAL)
ATTN: GRAHAM  COX                 PHONE NO : 425 408 0743
SPITZWEIDENWEG 30                 SE DECISION MADE: 26-FEB-14
JENA    GM D-07743                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ST SENSE NV 8 ARRAY COIL
RESONANCE INNOVATIONS LLC         510(k) NO: K140282(SPECIAL)
ATTN: RANDALL  JONES              PHONE NO : 402 934 2650   
9840 S 140th St Ste 8             SE DECISION MADE: 26-FEB-14
OMAHA NE 68138                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE
BRONCUS MEDICAL INC               510(k) NO: K133385(TRADITIONAL)
ATTN: ROBIN  BUSH                 PHONE NO : 650 428 1600   
1400 N. Shoreline Blvd., Bldg A, SSE DECISION MADE: 26-FEB-14
Mountain View CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMERGE MEDICAL BONE PLATE SYSTEM
EMERGE MEDICAL                    510(k) NO: K133536(TRADITIONAL)
ATTN: MICHELLE  POTVIN            PHONE NO : 720 459 6392   
720 S. COLORADO BLVD. SUITE 550-S SE DECISION MADE: 26-FEB-14
DENVER CO 80246                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEMUS 2 SYSTEM
EB NEURO, S.P.A.                  510(k) NO: K133517(TRADITIONAL)
ATTN: ALLISON  SCOTT, RAC         PHONE NO : 317 569 9500   
9001 WESLEYAN RD, STE 200         SE DECISION MADE: 26-FEB-14
INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MADSEN ACCUSCREEN TYPE 1077
GN OTOMETRICS                     510(k) NO: K132957(TRADITIONAL)
ATTN: DANIEL  KAMM, P.E.          PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 27-FEB-14
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK
ABBOTT MEDICAL OPTICS INC         510(k) NO: K133115(ABBREVIATED)
ATTN: ROSANNE  YETEMIAN           PHONE NO : 714 247 8282   
1700 E. ST. ANDREW PLACE          SE DECISION MADE: 27-FEB-14
SANTA ANA CA 92705                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M SERIES PATIENT MONITOR
MID-LINK CONSULTING CO., LTD      510(k) NO: K131876(SPECIAL)
ATTN: DIANA  HONG                 PHONE NO : 862 12 2815850
P.O. BOX 120-119                  SE DECISION MADE: 27-FEB-14
SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SARNS SOFT-FLOW EXTENDED AORTIC CANNULA
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K132811(TRADITIONAL)
ATTN: GARRY A COURTNEY            PHONE NO : 800 262 3304   
6200 JACKSON RD.                  SE DECISION MADE: 27-FEB-14
ANN ARBOR MI 48103                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: U&U STERILE PISTON SYRINGE WITHOUT NEEDLE
U&U MEDICAL TECHNOLOGY CO., LTD   510(k) NO: K132553(TRADITIONAL)
ATTN: XUEBO  WANG                 PHONE NO : 008 6135 64751751
DONGZHOU VILLAGE, HENGSHANQIAO TOWSE DECISION MADE: 27-FEB-14
CHANGZHOU, JIANGSU    CH 213119   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TARGET3D FUSION
CONVERGENT LIFE SCIENCES, INC.    510(k) NO: K140033(TRADITIONAL)
ATTN: DINESH  KUMAR               PHONE NO : 916 526 2775   
2377 GOLD MEADOW WAY SUITE 160    SE DECISION MADE: 27-FEB-14
GOLD RIVER CA 95670               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
ELLIPSE TECHNOLOGIES, INC.        510(k) NO: K140178(TRADITIONAL)
ATTN: JOHN  MCINTYRE              PHONE NO : 949 837 3600   
13900 ALTON PARKWAY SUITE 123     SE DECISION MADE: 27-FEB-14
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX IBALANCE TKA SYSTEM
ARTHREX, INC.                     510(k) NO: K133854(SPECIAL)
ATTN: LEON  BROWN, II             PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 27-FEB-14
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JINTRONIX REHABILITATION SYSTEM (JRS)
JINTRONIX INC.                    510(k) NO: K130847(TRADITIONAL)
ATTN: NAVNEET  SEKHON             PHONE NO : 905 854605 9
336 BRONTE ST SOUTH SUITE 224-225 SE DECISION MADE: 28-FEB-14
MILTON, ONTARIO    CA L9T 7W6     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE BITE GUARD
INTERNATIONAL PROFIT BUILDERS, INC510(k) NO: K132469(ABBREVIATED)
ATTN: BRYAN  TAPOCIK              PHONE NO : 909 864 7477   
7045 PALM AVE                     SE DECISION MADE: 28-FEB-14
HIGHLAND CA 92346                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
ETHICON, INC.                     510(k) NO: K132580(TRADITIONAL)
ATTN: PETER  CECCHINI             PHONE NO : 908 218 2457   
ROUTE 22 WEST P.O. BOX 151        SE DECISION MADE: 28-FEB-14
SOMERVILLE NJ 08876 0151          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLADIATOR ELITE PTA BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC CORP.           510(k) NO: K132810(TRADITIONAL)
ATTN: BETH  TOROK                 PHONE NO : 763 494 1273   
ONE SCIMED PLACE                  SE DECISION MADE: 28-FEB-14
MAPLE GROVE MN 55311 1566         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM
HYPER TECHNOLOGY INC              510(k) NO: K131777(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 120-119                  SE DECISION MADE: 28-FEB-14
SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ND: YAG LASER SYSTEM
BEIJING TOPLASER TECHNOLOGY CO., L510(k) NO: K133158(TRADITIONAL)
ATTN: ZHANG  XIAOSONG             PHONE NO : 86 10 64354759
East 3rd Floor, Building M7, No.1 SE DECISION MADE: 28-FEB-14
Beijing    CN 100015              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LERADO, POWER WHEELCHAIR
LERADO GLOBAL (MACAO COMMERCIAL OF510(k) NO: K130982(TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 852 524 75605
AVENIDA MARCIANO BAOTISTA, NO. 26-SE DECISION MADE: 28-FEB-14
Macau    CH CH                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANCED VIEWER
BRAINLAB, AG                      510(k) NO: K132763(TRADITIONAL)
ATTN: ALEXANDER  SCHWIERSCH       PHONE NO : 4 989 9915680
KAPELLENSTR. 12                   SE DECISION MADE: 28-FEB-14
FELDKIRCHEN    GM 85622           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM
SYNTHES (USA) PRODUCTS, LLC       510(k) NO: K131548(TRADITIONAL)
ATTN: HEMAL  MEHTA                PHONE NO : 610 719 5424   
1301 GOSHEN PKWY                  SE DECISION MADE: 28-FEB-14
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMARC FIDUCIAL MARKER
CARBON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K132064(TRADITIONAL)
ATTN: ANDREW J ADAMS              PHONE NO : 651 653 8512   
1290 Hammond Rd                   SE DECISION MADE: 28-FEB-14
Saint Paul MN 55110               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM
SUZHOU ANKE MEDICAL SYSTEM CO., LT510(k) NO: K131896(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 120-119                  SE DECISION MADE: 28-FEB-14
SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIXOS SCREW SYSTEM
STRYKER TRAUMA AG                 510(k) NO: K133451(TRADITIONAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 6461   
325 CORPORATE DR                  SE DECISION MADE: 28-FEB-14
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
CARDIOVASCULAR SYSTEMS, INC.      510(k) NO: K133999(SPECIAL)
ATTN: BLAIR  BUTH                 PHONE NO : 651 259 2032   
651 CAMPUS DRIVE                  SE DECISION MADE: 28-FEB-14
SAINT PAUL MN 55112               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SCENIUM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133654(TRADITIONAL)
ATTN: MARIA  EBIO                 PHONE NO : 865 218 2873   
2501 NORTH BARRINGTON RD.         SE DECISION MADE: 28-FEB-14
HOFFMAN ESTATES IL 60192          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE DOME S6C
NDS SURGICAL IMAGING              510(k) NO: K133609(SPECIAL)
ATTN: JIM  LENG                   PHONE NO : 408 776 0085   
5750 HELLYER AVENUE               SE DECISION MADE: 28-FEB-14
SAN JOSE CA 95138                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OXICARE FINGERTIP PULSE OXIMETER
DELBIO INCORPORATION              510(k) NO: K133090(SPECIAL)
ATTN: ERICA  LI                   PHONE NO : 510 668 5141   
4405 CUSHING PKWY.                SE DECISION MADE: 28-FEB-14
FREMONT CITY CA 94538             510(k) STATEMENT

DEVICE: OSTEOMED EXTREMIFUSE SYSTEM
OSTEOMED                          510(k) NO: K140283(SPECIAL)
ATTN: BLESSON  ABRAHAM            PHONE NO : 972 677 4795   
3885 ARAPAHO ROAD                 SE DECISION MADE: 28-FEB-14
ADDISON TX 75001                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ICONIX ALL SUTURE ANCHORS
STRYKER CORP.                     510(k) NO: K133671(TRADITIONAL)
ATTN: KELLY  KUCHARCZYK           PHONE NO : 303 336 7285   
HOWMEDICA OSTEONICS               SE DECISION MADE: 28-FEB-14
DENVER CO 80206                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TENSYN BAND
DALLEN MEDICAL, INC.              510(k) NO: K133858(TRADITIONAL)
ATTN: AL  MEMMOLO                 PHONE NO : 949 218 0030   
1046 Calle Recodo Ste G           SE DECISION MADE: 28-FEB-14
San Clemente CA 92673             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRESTO BREAST BIOPSY DEVICE
SONTINA MEDICAL, LLC              510(k) NO: K133702(SPECIAL)
ATTN: ROBERT  PELIKS              PHONE NO : 415 873 3831   
111 SUTRO HEIGHTS AVENUE          SE DECISION MADE: 28-FEB-14
SAN FRANCISCO CA 94121            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHARLOTTE CLAW PLATE SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K133715(TRADITIONAL)
ATTN: LESLIE  FITCH               PHONE NO : 901 867 4120   
5677 AIRLINE RD.                  SE DECISION MADE: 28-FEB-14
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONODERM SURGICAL SUTURE
SURGICAL SPECIALTIES CORP.        510(k) NO: K140227(SPECIAL)
ATTN: KIRSTEN  STOWELL FRANCO     PHONE NO : 610 404 3367   
100 DENNIS DR.                    SE DECISION MADE: 28-FEB-14
READING PA 19606                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS
ARJOHUNTLEIGH POLSKA SP Z.O.O.    510(k) NO: K133119(TRADITIONAL)
ATTN: DAVID  MOYNHAM              PHONE NO : 44 2920 447084
35 PORTMANMOOR ROAD               SE DECISION MADE: 28-FEB-14
CARDIFF, S. GLAMORGAN    UK CF24 5510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NMI DIALYSIS CATHETER
NAVILYST MEDICAL, INC.            510(k) NO: K131260(TRADITIONAL)
ATTN: LORRAINE M HANLEY           PHONE NO : 508 658 7945   
26 FOREST STREET                  SE DECISION MADE: 14-FEB-14
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   249                                     
                                                 TOTAL WITH SUMMARIES        233                                     
                                                 TOTAL WITH STATEMENTS        16