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U.S. Department of Health and Human Services

Medical Devices

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April 2011 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD April 2011


DEVICE: VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM
C.R. BARD, INC.                   510(k) NO: K110820(SPECIAL)
ATTN: KETI  SINO                  PHONE NO : 401 825 8575   
100 CROSSINGS BOULEVARD           SE DECISION MADE: 01-APR-11
WARWICK RI 02886                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSSEOTITE II MODEL XIFOSSXXX
BIOMET 3I, INC.                   510(k) NO: K100724(TRADITIONAL)
ATTN: JOSE E CABRERA              PHONE NO : 561 776 6840   
4555 RIVERSIDE DR.                SE DECISION MADE: 01-APR-11
PALM BEACH GARDENS FL 33410       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01
CEDARS-SINAI MEDICAL CENTER       510(k) NO: K100714(TRADITIONAL)
ATTN: DAVID R DILLS               PHONE NO : 904 519 8040   
8787 SOUTHSIDE BLVD., #719        SE DECISION MADE: 01-APR-11
JACKSONVILLE FL 32256             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPRESSYN BAND
DALLEN MEDICAL                    510(k) NO: K101484(TRADITIONAL)
ATTN: AL  MEMMOLO                 PHONE NO : 949 218 0030   
1046 CALLE RECODO SUITE G         SE DECISION MADE: 01-APR-11
SAN CLEMENTE CA 92673             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
ACCLARENT, INC.                   510(k) NO: K103595(TRADITIONAL)
ATTN: GURVINDER  SINGH NANDA      PHONE NO : 650 687 5414   
1525-B O'BRIEN DR.                SE DECISION MADE: 01-APR-11
MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD
CONSENSUS ORTHOPEDICS, INC.       510(k) NO: K110542(TRADITIONAL)
ATTN: MATTHEW  HULL               PHONE NO : 916 355 7100   
1115 WINDFIELD WAY, SUITE 100     SE DECISION MADE: 01-APR-11
EL DORADO HILLS CA 95762 9623     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXPEDIUM SYSTEM, VIPER SYSTEM
DEPUY SPINE, INC.                 510(k) NO: K110216(SPECIAL)
ATTN: EUGENE  BANG                PHONE NO : 508 977 3966   
325 PARAMOUNT DR.                 SE DECISION MADE: 01-APR-11
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K110522(SPECIAL)
ATTN: NICHOLAS  TABRIZI           PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 01-APR-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL
GE MEDICAL SYSTEMS, LLC           510(k) NO: K110610(SPECIAL)
ATTN: MICHELLE  SCHEIDT           PHONE NO : 262 521 6102   
3200 N. GRANDVIEW BLVD.           SE DECISION MADE: 01-APR-11
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYLATOPICPLUS CREAM
PRECISION DERMATOLOGY INCORPORATED510(k) NO: K110727(SPECIAL)
ATTN: RONALD M GURGE              PHONE NO : 401 762 2000   
900 HIGHLAND CORPORATE DRIVE      SE DECISION MADE: 01-APR-11
CUMBERLAND RI 02864               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS
ABBOT LABORATORIES                510(k) NO: K102699(TRADITIONAL)
ATTN: JUDITH  WALLACH             PHONE NO : 847 937 1132   
100 ABBOTT PARK RD. DEPT. 9V6 AP6CSE DECISION MADE: 01-APR-11
ABBOTT PARK IL 60064 6092         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...
EXACTECH, INC.                    510(k) NO: K110708(SPECIAL)
ATTN: LINDY  KNISELY              PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 01-APR-11
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALYTE Y-MESH GRAFT
C.R. BARD, INC.                   510(k) NO: K101722(TRADITIONAL)
ATTN: SCOTT  ROBIRDS              PHONE NO : 770 784 6722   
8195 INDUSTRIAL BLVD.             SE DECISION MADE: 01-APR-11
COVINGTON GA 30014                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERRAD SEALSURE CHEMICAL INDICATOR TAPE
ADVANCED STERILIZATION PRODUCTS   510(k) NO: K103219(TRADITIONAL)
ATTN: NANCY  CHU                  PHONE NO : 949 453 6435   
33 TECHNOLOGY DR.                 SE DECISION MADE: 01-APR-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERRAD CHEMICAL INDICATOR STRIP
ADVANCED STERILIZATION PRODUCTS   510(k) NO: K103218(TRADITIONAL)
ATTN: NANCY  CHU                  PHONE NO : 949 453 6435   
33 TECHNOLOGY DR.                 SE DECISION MADE: 01-APR-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TORFLEX TRANSSEPTAL GUIDING SHEATH
BAYLIS MEDICAL CO., INC.          510(k) NO: K102948(TRADITIONAL)
ATTN: MEGHAL  KHAKHAR             PHONE NO : 905 602 4875
2645 MATHESON BLVD. E             SE DECISION MADE: 01-APR-11
MISSISSAUGA, ONTARIO    CA L4W 5S4510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE ARTAS SYSTEM FROM RESTORATION ROBOTICS
RESTORATION ROBOTICS, INC         510(k) NO: K103428(TRADITIONAL)
ATTN: KIT  CARIQUITAN             PHONE NO : 408 400 0856   
155-A MOFFETT PARK DRIVE SUITE 210SE DECISION MADE: 04-APR-11
SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT
MEDICA CORP.                      510(k) NO: K101088(TRADITIONAL)
ATTN: PHOTIOS  MAKRIS             PHONE NO : 781 275 4892   
5 OAK PARK DRIVE                  SE DECISION MADE: 04-APR-11
BEDFORD MA 01730                  510(k) STATEMENT

DEVICE: NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
TANGSHAN BAOJIE GLOVE CO., LTD    510(k) NO: K110185(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
ROOM 1606 BLDG1.JIANXIANG YUAN NO.SE DECISION MADE: 04-APR-11
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL FOREHEAD THERMOMETER
K-JUMP HEALTH CO., LTD.           510(k) NO: K103617(SPECIAL)
ATTN: JASON  CHENG                PHONE NO : 886 222 991378
NO. 56, WU KUNG 5TH RD., WU KU INDSE DECISION MADE: 04-APR-11
TAIPEI HSIEN    TW 248            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFIED HD GUIDE CATHETER
CONCENTRIC MEDICAL, INC.          510(k) NO: K110483(SPECIAL)
ATTN: KIRSTEN  VALLEY             PHONE NO : 650 810 1707   
301 E. EVELYN AVE.                SE DECISION MADE: 04-APR-11
MOUNTAIN VIEW CA 94041            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VAULT ALIF SYSTEM
SPINAL USA                        510(k) NO: K103369(TRADITIONAL)
ATTN: LINDA  POLK                 PHONE NO : 601 420 4244   
2050 EXECUTIVE DR.                SE DECISION MADE: 04-APR-11
PEARL MS 39208                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RT600
RESTORATIVE THERAPIES INC.        510(k) NO: K103366(TRADITIONAL)
ATTN: SCOTT  SIMCOX               PHONE NO : 800 609 9166   
907 SOUTH LAKEWOOD AVE.           SE DECISION MADE: 04-APR-11
BALTIMORE MD 21224                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KNEEALIGN SYSTEM
ORTHALIGN, INC                    510(k) NO: K103829(TRADITIONAL)
ATTN: AMY  WALTERS                PHONE NO : 949 923 9400   
338 VISTA MADERA                  SE DECISION MADE: 04-APR-11
NEWPORT BEACH CA 92660            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM
SOUND SURGICAL TECHNOLOGIES LLC.  510(k) NO: K110255(TRADITIONAL)
ATTN: STEPHEN C SMITH             PHONE NO : 720 240 2970   
357 S. MCCASLIN BLVD. #100        SE DECISION MADE: 04-APR-11
LOUISVILLE CO 80027               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CARDIOHELP SYSTEM
MAQUET CARDIOPULMONARY AG         510(k) NO: K102726(TRADITIONAL)
ATTN: ROLAND  JEHLE               PHONE NO : 004 974 78921373
HECHINGER STRASSE 38              SE DECISION MADE: 04-APR-11
HIRRLINGEN    GM 72145            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRAINLAB KNEE
BRAINLAB AG                       510(k) NO: K102990(SPECIAL)
ATTN: ALEXANDER  SCHWIERSCH       PHONE NO : 498 999 15680
KAPELLENSTRASSE 12                SE DECISION MADE: 04-APR-11
FELDKIRCHEN    GM 85622           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPRESSION COMPOUND
SPOFADENTAL                       510(k) NO: K110378(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602   
1717 WEST COLLINS AVENUE          SE DECISION MADE: 05-APR-11
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
CHURCH & DWIGHT CO., INC.         510(k) NO: K100767(TRADITIONAL)
ATTN: JOSEPH  CICCONE             PHONE NO : 609 497 7251   
469 NORTH HARRISON STREET         SE DECISION MADE: 05-APR-11
PRINCETON NJ 08543                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1
SALIENT SURGICAL TECHNOLOGIES     510(k) NO: K101057(TRADITIONAL)
ATTN: KERRI  MORTON               PHONE NO : 603 742 1515   
180 INTERNATIONAL DRIVE           SE DECISION MADE: 05-APR-11
PORTSMOUTH NH 03801               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CUTERA GENESISPLUS LASER SYSTEM
CUTERA, INC.                      510(k) NO: K103626(TRADITIONAL)
ATTN: CONNIE  HOY                 PHONE NO : 415 657 5592   
3240 BAYSHORE BLVD                SE DECISION MADE: 05-APR-11
BRISBANE CA 94005                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM
TORNIER, INC.                     510(k) NO: K103262(TRADITIONAL)
ATTN: HOWARD L SCHRAYER           PHONE NO : 609 924 9510   
100 CUMMINGS CENTER SUITE 444C    SE DECISION MADE: 05-APR-11
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS
RESPIRONICS CALIFORNIA, INC.      510(k) NO: K102985(TRADITIONAL)
ATTN: TAMATHA  LEY                PHONE NO : 760 918 1026   
2271 COSMOS CT.                   SE DECISION MADE: 05-APR-11
CARLSBAD CA 92011                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRITY SPINAL CARE SYSTEM
INTEGRA LIFE SCIENCES             510(k) NO: K103248(TRADITIONAL)
ATTN: JAMES J GIBSON              PHONE NO : 702 997 7190   
5795 SOUTH SANDHILL ROAD SUITE F, SE DECISION MADE: 05-APR-11
LAS VEGAS NV 89120                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: RT200
RESTORATIVE THERAPIES INC.        510(k) NO: K103370(TRADITIONAL)
ATTN: ANDREW  BARRISKILL          PHONE NO : 800 609 9166   
907 SOUTH LAKEWOOD AVE.           SE DECISION MADE: 05-APR-11
BALTIMORE MD 21224                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMOSIL LA POSITIVE CONTROL
INSTRUMENTATION LABORATORY CO.    510(k) NO: K102552(TRADITIONAL)
ATTN: CAROL  MARBLE               PHONE NO : 781 861 4467   
180 HARTWELL ROAD                 SE DECISION MADE: 05-APR-11
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESTELITE COLOR
TOKUYAMA DENTAL CORPORATION       510(k) NO: K110178(TRADITIONAL)
ATTN: KEITH A BARRITT             PHONE NO : 202 783 5070   
1425 K STREET, N.W. SUITE 1100    SE DECISION MADE: 05-APR-11
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHARPS CONTAINER
NOBLE MARKETING                   510(k) NO: K110262(TRADITIONAL)
ATTN: ALLISON  SCOTT              PHONE NO : 317 569 9500   
11460 N. MERIDIAN ST. SUITE 150   SE DECISION MADE: 05-APR-11
CARMEL IN 46032                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: REVERSE MEDICAL REFLEX GUIDE CATHETER
REVERSE MEDICAL CORPORATION       510(k) NO: K110055(TRADITIONAL)
ATTN: AMY  ESKINA                 PHONE NO : 949 215 0660   
13900 ALTON PARKWAY SUITE 123     SE DECISION MADE: 05-APR-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TEMPOROMANIBULAR COIL 15
ESAOTE S.P.A.                     510(k) NO: K110373(TRADITIONAL)
ATTN: DONATELLA  RAGGHIANTI       PHONE NO : 011 390 106547259
VIA SIFFREDI 58                   SE DECISION MADE: 06-APR-11
GENOVA    IT 16153                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
CARD GUARD SCIENTIFIC SURVIVAL LTD510(k) NO: K110499(SPECIAL)
ATTN: CLAY  ANSELMO               PHONE NO : 303 223 4303   
555 ZANG ST SUITE 100             SE DECISION MADE: 06-APR-11
LAKEWOOD CO 80228                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES
US MEDICAL INNOVATIONS LLC        510(k) NO: K100669(TRADITIONAL)
ATTN: KRISTA  OAKES               PHONE NO : 512 327 9997   
1705 S. CAPITAL OF TEXAS HWY SUITESE DECISION MADE: 06-APR-11
AUSTIN TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K100375(TRADITIONAL)
ATTN: PAMELA  JURGA               PHONE NO : 302 631 8891   
PO BOX 6101 M/S 514               SE DECISION MADE: 06-APR-11
NEWARK DE 19714 6101              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST
ALCOPRO, INC.                     510(k) NO: K102225(TRADITIONAL)
ATTN: PERRY  RUCKER               PHONE NO : 310 415 7093   
1560 E. EDINGER AVENUE, SUITE B   SE DECISION MADE: 06-APR-11
SANTA ANA CA 92705                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HAIRMAX LASERCOMB
LEXINGTON INTERNATIONAL, LLC      510(k) NO: K103368(TRADITIONAL)
ATTN: CASPER E ULDRIKS ESQ.       PHONE NO : 202 518 6385   
1400 SIXTEENTH STREET, NW SUITE 40SE DECISION MADE: 06-APR-11
WASHINGTON DC 20036               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO MBF
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K110494(SPECIAL)
ATTN: ELAINE  CHANG               PHONE NO : 847 304 7516   
2501 NORTH BARRINGTON RD.         SE DECISION MADE: 06-APR-11
HOFFMAN ESTATES IL 60192          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISA CO2, ISA AX+, ISA OR+
PHASEIN AB                        510(k) NO: K103604(TRADITIONAL)
ATTN: DAVID  WEISSBURG            PHONE NO : 608 770 0223   
4213 WINNEQUAH DR.                SE DECISION MADE: 06-APR-11
MADISON WI 53716                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRONTOSAN WOUND IRRIGATION SOLUTION
B. BRAUN MEDICAL, INC.            510(k) NO: K110744(TRADITIONAL)
ATTN: NANCY  SKOCYPEC             PHONE NO : 610 596 2796   
901 MARCON BLVD.                  SE DECISION MADE: 06-APR-11
ALLENTOWN PA 18109 9341           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTIPLE BIOPSY SYSTEM
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K103326(TRADITIONAL)
ATTN: CARROLL L MARTIN            PHONE NO : 440 639 4494   
5976 HEISELY RD.                  SE DECISION MADE: 06-APR-11
MENTOR OH 44060                   510(k) STATEMENT

DEVICE: NEWTOM 5G / NEWTOM 5G VERSION FP
QR S.R.L.                         510(k) NO: K110260(SPECIAL)
ATTN: LORENZO  BORTOLOTTI         PHONE NO : 390 458 202727
VIA SILVESTRINI 20                SE DECISION MADE: 06-APR-11
VERONA, VR    IT 37135            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESUSCI FLOW; RESUSCI FLOW 104
ATOM MEDICAL CORPORATION          510(k) NO: K102542(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSTAGE DRIVE             SE DECISION MADE: 06-APR-11
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VELA XL
STARMEDTEC GMBH                   510(k) NO: K103654(TRADITIONAL)
ATTN: GREGOR  WEIDEMANN           PHONE NO : 498 151 268610
KREUZSTRASSE 22                   SE DECISION MADE: 06-APR-11
STARNBERG    GM 82319             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROLIFE DIGITAL UNDERARM THERMOMETER
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K103680(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 949 706 7456   
55 NORTHERN BOULEVARD SUITE 200   SE DECISION MADE: 06-APR-11
GREAT NECK NY 10021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE BLLOD COLLECTION NEEDLE
WEIHAI HONGYU MEDICAL DEVICES CO.,510(k) NO: K103587(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 164 264467
P.O. BOX 237-023                  SE DECISION MADE: 06-APR-11
SHANGHAI    CH 264200             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K110169(TRADITIONAL)
ATTN: KATHLEEN ANN  DRAY-LYONS    PHONE NO : 781 826 4551   
500 GBC DRIVE PO BOX 6101         SE DECISION MADE: 07-APR-11
NEWARK DE 19714                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCULIF CAGE
COALIGN INNOVATIONS, INC.         510(k) NO: K110270(SPECIAL)
ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5800   
1331 H STREET NW 12TH FLOOR       SE DECISION MADE: 07-APR-11
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XPERT C. DIFFICLE/EPI ASSAY
CEPHEID                           510(k) NO: K110203(TRADITIONAL)
ATTN: RUSSEL K ENNS               PHONE NO : 408 400 8230   
904 CARIBBEAN DRIVE               SE DECISION MADE: 07-APR-11
SUNNYVALE CA 94089 1189           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOUNTAINEER OCT SPINAL SYSTEM
DEPUY SPINE, INC.                 510(k) NO: K110353(SPECIAL)
ATTN: LUKE  BULINO                PHONE NO : 508 828 3267   
325 PARAMOUNT DR.                 SE DECISION MADE: 07-APR-11
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XVAC
SORIN GROUP ITALIA S.R.L.         510(k) NO: K110782(TRADITIONAL)
ATTN: BARRY  SALL                 PHONE NO : 781 434 4742   
195 WEST STREET                   SE DECISION MADE: 07-APR-11
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNAPSE 3D LIVER ANALYSIS
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K110186(TRADITIONAL)
ATTN: KIMERLY A SHARP             PHONE NO : 203 602 3665   
419 WEST AVE.                     SE DECISION MADE: 07-APR-11
STAMFORD CT 06902 6300            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMS AIR-FLOW MASTER PIEZON
EMS ELECTRO MEDICAL SYSTEMS SA    510(k) NO: K110173(TRADITIONAL)
ATTN: CYNTHIA J M. NOLTE, PH.D, RAPHONE NO : 919 859 4207   
49 PLAIN ST.                      SE DECISION MADE: 07-APR-11
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMBITRANS MONITORING SETS AND ACCESSORIES
B. BRAUN MELSUNGEN AG             510(k) NO: K102033(ABBREVIATED)
ATTN: LISA  GIAQUINTO             PHONE NO : 610 596 2354   
901 MARCON BLVD                   SE DECISION MADE: 07-APR-11
ALLENTOWN PA 18109                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 4D SONO-SCAN 1.0
TOMTEC IMAGING SYSTEMS, GMBH      510(k) NO: K110595(TRADITIONAL)
ATTN: INGE  SCHEIDT               PHONE NO : 498 932 175515
EDISONSTRASSE 6                   SE DECISION MADE: 07-APR-11
UNTERSCHLEISSHEIM    GM D-85716   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
IMPACT INSTRUMENTATION, INC.      510(k) NO: K103318(TRADITIONAL)
ATTN: SUSAN  MCNEVIN              PHONE NO : 973 882 1212   
27 FAIRFIELD PL. P.O. BOX 508     SE DECISION MADE: 07-APR-11
WEST CALDWELL NJ 07006 0508       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UTA AND UHA
UTA                               510(k) NO: K102467(TRADITIONAL)
ATTN: ANGELA  BLACKWELL           PHONE NO : 704 450 9934   
3318 SUCCESFUL WAY                SE DECISION MADE: 07-APR-11
DAYTON OH 45414                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET
RANDOX LABORATORIES, LTD.         510(k) NO: K092269(TRADITIONAL)
ATTN: P  ARMSTRONG                PHONE NO : 440 289 4422413
55 DIAMOND RD.                    SE DECISION MADE: 08-APR-11
CRUMLIN, COUNTY ANTRIM    UK BT29 510(k) STATEMENT

DEVICE: INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000
INTUITIVE SURGICAL, INC.          510(k) NO: K101581(TRADITIONAL)
ATTN: BRANDON  HANSEN             PHONE NO : 408 523 2100   
1266 KIFER ROAD                   SE DECISION MADE: 08-APR-11
SUNNYVALE CA 94086 5206           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRELUDE III TONGUE SUSPENSION SYSTEM
SIESTA MEDICAL, INC.              510(k) NO: K110127(SPECIAL)
ATTN: MICHAEL  KOLBER             PHONE NO : 408 505 6626   
101 CHURCH STREET SUITE 3         SE DECISION MADE: 08-APR-11
LOS GATOS CA 95030                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AGILIS ES STEERABLE INTRODUCER
ST. JUDE MEDICAL                  510(k) NO: K103083(TRADITIONAL)
ATTN: LAURA  MOEN-FTACEK          PHONE NO : 651 756 2957   
14901 DEVEAU PLACE                SE DECISION MADE: 08-APR-11
MINNETONKA MN 55345 2126          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PAIRED HYDROGEL ELECTRODE
NEUROVISION MEDICAL PRODUCTS, INC.510(k) NO: K110138(SPECIAL)
ATTN: CHRISTINE  VERGELY          PHONE NO : 805 866 6999   
2225 SPERRY AVE, SUITE 1000       SE DECISION MADE: 08-APR-11
VENTURA CA 93003                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUITY WHISPER VIEW GUIDE WIRES
BOSTON SCIENTIFIC CORP.           510(k) NO: K110479(SPECIAL)
ATTN: KIRSTIN  JOHNSTON           PHONE NO : 651 582 5871   
4100 HAMLINE AVE NORTH MS 9-330   SE DECISION MADE: 08-APR-11
ST. PAUL MN 55112                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET
ETHICON ENDO-SURGERY, LLC         510(k) NO: K103672(TRADITIONAL)
ATTN: DENNIS  HAHN                PHONE NO : 513 337 3134   
4545 CREEK ROAD                   SE DECISION MADE: 08-APR-11
CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PORTABLE X-RAY SYSTEM
DIGIMED CORPORATION               510(k) NO: K103600(TRADITIONAL)
ATTN: KIM  ANTOL                  PHONE NO : 847 419 0669   
1607 N. BARCLAY AVE.              SE DECISION MADE: 08-APR-11
BUFFALO GROVE IL 60089            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP
THERAPEUTICS 101, INC (DBA PRESSUR510(k) NO: K110563(TRADITIONAL)
ATTN: JULIE  POWELL               PHONE NO : 269 720 1329   
611 WEST 5TH STREET THIRD FLOOR   SE DECISION MADE: 08-APR-11
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTIMATE VIT ENHAMCER (UVE)
MEDICAL INSTRUMENT DEVELOPMENT LAB510(k) NO: K102222(TRADITIONAL)
ATTN: LINDA  UPTON                PHONE NO : 510 357 3952   
557 MC CORMICK STREET             SE DECISION MADE: 08-APR-11
SAN LEANDRO CA 94577              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS
TOMTEC IMAGING SYSTEMS, GMBH      510(k) NO: K110667(TRADITIONAL)
ATTN: INGE  SCHEIDT               PHONE NO : 498 932 175515
EDISONSTRASSE 6                   SE DECISION MADE: 08-APR-11
UNTERSCHLEISSHEIM    GM D-85716   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACAM 5 AUDIOMETER SYSTEM
ACOUSTICON GMBH                   510(k) NO: K103298(TRADITIONAL)
ATTN: MAUREEN  GARNER             PHONE NO : 732 779 7422   
1983 HAZELWOOD ROAD               SE DECISION MADE: 08-APR-11
TOMS RIVER NJ 08754               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
MICROGENICS CORP.                 510(k) NO: K101742(TRADITIONAL)
ATTN: LISA  CHARTER               PHONE NO : 510 979 5142   
46360 FREMONT BLVD                SE DECISION MADE: 08-APR-11
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
MICROGENICS CORP.                 510(k) NO: K101744(TRADITIONAL)
ATTN: LISA  CHARTER               PHONE NO : 510 979 5142   
46360 FREMONT BLVD                SE DECISION MADE: 08-APR-11
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY
MICROGENICS CORP.                 510(k) NO: K101745(TRADITIONAL)
ATTN: LISA  CHARTER               PHONE NO : 510 979 5142   
46360 FREMONT BLVD                SE DECISION MADE: 08-APR-11
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
MICROGENICS CORP.                 510(k) NO: K101746(TRADITIONAL)
ATTN: LISA  CHARTER               PHONE NO : 510 979 5142   
46360 FREMONT BLVD                SE DECISION MADE: 08-APR-11
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XEROS DRY MOUTH PUMP
LORIN TECHNOLOGIES CORPORATION    510(k) NO: K110116(TRADITIONAL)
ATTN: AL  TOMAN                   PHONE NO : 919 341 4128   
436 WOODLAND DR                   SE DECISION MADE: 08-APR-11
SWANSBORO NC 28584                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18
ESAOTE S.P.A.                     510(k) NO: K110802(SPECIAL)
ATTN: ALLISON  SCOTT              PHONE NO : 317 569 9500   
11460 N MERIDIAN ST SUITE 150     SE DECISION MADE: 08-APR-11
CARMEL IN 46032                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NICOLET WIRELESS EEG
CAREFUSION 209, INC.              510(k) NO: K103140(TRADITIONAL)
ATTN: ROBERT  BURDGE              PHONE NO : 608 829 8655   
1850 Deming Way                   SE DECISION MADE: 08-APR-11
Middleton WI 53562                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: HYDROFIX VASO SHIELD
MIMEDX GROUP, INC                 510(k) NO: K101805(TRADITIONAL)
ATTN: SALLY  THORSEN              PHONE NO : 678 384 6720   
811 LIVINGSTON COURT SE SUITE B   SE DECISION MADE: 08-APR-11
MARIETTA GA 30067                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
MICROGENICS CORP.                 510(k) NO: K101752(TRADITIONAL)
ATTN: LISA  CHARTER               PHONE NO : 510 979 5142   
46360 FREMONT BLVD                SE DECISION MADE: 08-APR-11
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
MICROGENICS CORP.                 510(k) NO: K101753(TRADITIONAL)
ATTN: LISA  CHARTER               PHONE NO : 510 979 5142   
46360 FREMONT BLVD                SE DECISION MADE: 08-APR-11
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY
MICROGENICS CORP.                 510(k) NO: K101754(TRADITIONAL)
ATTN: LISA  CHARTER               PHONE NO : 510 979 5142   
46360 FREMONT BLVD                SE DECISION MADE: 08-APR-11
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAKE 1 ADVANCED RIGID TRAY
KERR CORPORATION                  510(k) NO: K110092(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602   
1717 WEST COLLINS AVE.            SE DECISION MADE: 08-APR-11
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UF-760AG
FUKUDA DENSHI CO., LTD.           510(k) NO: K110920(TRADITIONAL)
ATTN: LORAN  VAN NOY              PHONE NO : 425 881 7737   
17725 N.E. 65TH STREET BLDG C     SE DECISION MADE: 08-APR-11
REDMOND WA 98052 4911             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: AMBIT TUNNELER
SUMMIT MEDICAL PRODUCTS, INC      510(k) NO: K110814(ABBREVIATED)
ATTN: MARKO V AMEN                PHONE NO : 801 214 3464   
2480 SOUTH MAIN STREET #212       SE DECISION MADE: 08-APR-11
SALT LAKE CITY UT 84118           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: APEX ER. YAG / IPL SYSTEM
SANDSTONE MEDICAL TECHNOLOGIES LLC510(k) NO: K110304(TRADITIONAL)
ATTN: MARK  ROHRER                PHONE NO : 205 290 8251   
105 CITATION COURT                SE DECISION MADE: 08-APR-11
BIRMINGHAM AL 35209               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SCENARIA WHOLE-BODY X-RAY CT SYSTEM
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K101888(TRADITIONAL)
ATTN: DOUG  THISTLETHWAITE        PHONE NO : 330 425 1313   
1959 SUMMIT COMMERCE PARK         SE DECISION MADE: 08-APR-11
TWINSBURG OH 44087                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATRICURE BIPOLAR SYSTEM
ATRICURE, INC.                    510(k) NO: K110117(TRADITIONAL)
ATTN: JAMES  LUCKY, RAC           PHONE NO : 513 755 5754   
6217 CENTER PARK DRIVE            SE DECISION MADE: 08-APR-11
WEST CHESTER OH 45069             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT
ASTRA TECH, INC.                  510(k) NO: K103759(TRADITIONAL)
ATTN: BETSY A BROWN               PHONE NO : 847 560 4406   
8944 TAMAROA TERR.                SE DECISION MADE: 08-APR-11
SKOKIE IL 60076                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEWPHEW ULTRABRAID II SUTURE
SMITH & NEWPHEW, INC              510(k) NO: K101377(TRADITIONAL)
ATTN: CHRISTINA  FLORES           PHONE NO : 508 261 3705   
150 MINUTEMAND ROAD               SE DECISION MADE: 08-APR-11
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DENOVO TEDDY GEL INFANT HEEL WARMER
DENOVO PRODUCTS LLC               510(k) NO: K103549(TRADITIONAL)
ATTN: DALE  WALTERS               PHONE NO : 239 245 7030   
17051 Alico Commerce Court Unit 3 SE DECISION MADE: 08-APR-11
Fort Myers FL 33967               510(k) STATEMENT

DEVICE: LP CAGE
MEDYSSEY CO., LTD.                510(k) NO: K110067(TRADITIONAL)
ATTN: RICH  JANSEN                PHONE NO : 612 281 5505   
13540 GUILD AVE                   SE DECISION MADE: 08-APR-11
APPLE VALLEY MN 55124             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATAMA SYSTEM
MONTERIS MEDICAL, INC.            510(k) NO: K110411(TRADITIONAL)
ATTN: JEFF  WILSON                PHONE NO : 204 272 2220
100 - 78 Innovation Drive         SE DECISION MADE: 08-APR-11
Winnipeg    CA R3T 6C2            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER
VASCULAR SOLUTIONS, INC.          510(k) NO: K102212(TRADITIONAL)
ATTN: LISA  GALLATIN              PHONE NO : 763 656 4399   
6464 SYCAMORE COURT               SE DECISION MADE: 08-APR-11
MINNEAPOLIS MN 55369              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE
HOWMEDICA OSTEONICS CORP          510(k) NO: K101072(TRADITIONAL)
ATTN: KAREN  ARIEMMA              PHONE NO : 201 831 5718   
325 CORPORATE DR.                 SE DECISION MADE: 11-APR-11
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LATARJET CORTICAL SCREW SET
T.A.G. MEDICAL PRODUCTS CORPORATIO510(k) NO: K110763(SPECIAL)
ATTN: GEORGE J HATTUB             PHONE NO : 508 479 6116   
291 HILLSIDE AVENUE               SE DECISION MADE: 11-APR-11
SOMERSET MA 02726                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAPER OXINIUM FEMORAL HEAD
SMITH & NEPHEW, INC.              510(k) NO: K110101(TRADITIONAL)
ATTN: SHEREEN  MYERS              PHONE NO : 901 396 2121   
1450 EAST BROOKS RD.              SE DECISION MADE: 11-APR-11
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMC-20 PORTABLE DENTAL CART MODEL AMC-20
ASEPTICO, INC.                    510(k) NO: K101332(TRADITIONAL)
ATTN: CHERIE A TREGONING          PHONE NO : 425 487 3157   
8333 216TH ST., S.E.              SE DECISION MADE: 11-APR-11
WOODINVILLE WA 98072              510(k) STATEMENT

DEVICE: DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K100321(TRADITIONAL)
ATTN: ROSE  MARINELLI             PHONE NO : 302 631 8805   
MS 514, PO BOX 6101               SE DECISION MADE: 12-APR-11
NEWARK DE 19714 6101              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO.CT CARDIAC FUNCTION
SIEMENS AG                        510(k) NO: K110366(TRADITIONAL)
ATTN: RALF  HOFFMANN              PHONE NO : 
51 VALLEY STREAM PKWY             SE DECISION MADE: 12-APR-11
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PROPEP DELIVERY DEVICE
RHYTHMLINK INTERNATIONAL, LLC     510(k) NO: K103200(TRADITIONAL)
ATTN: JAMES M MEWBORNE            PHONE NO : 803 252 1222   
1140 FIRST STREET SOUTH           SE DECISION MADE: 12-APR-11
COLUMBIA SC 29209                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFUSION ADAPTER C100
CARMEL PHARMA AB.                 510(k) NO: K110023(TRADITIONAL)
ATTN: KJELL  ANDREASSON           PHONE NO : 463 170 30400
AMINOGATAN 30                     SE DECISION MADE: 12-APR-11
MOLNDAL    SW S431 53             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050
CORELEADER BIOTECH CO., LTD.      510(k) NO: K102943(TRADITIONAL)
ATTN: IAN  LI                     PHONE NO : 886 269 68880
19F NO. 100, SEC 1 SINTAI 5TH RD, SE DECISION MADE: 12-APR-11
TAIPEI, TAIWAN    TW 22102        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WALDO PATIENT MONITOR
WALDO HEALTH                      510(k) NO: K110334(TRADITIONAL)
ATTN: ALAN R WEISS                PHONE NO : 512 219 0302   
4505 SPICEWOOD SPRINGS ROAD, SUITESE DECISION MADE: 12-APR-11
AUSTIN TX 78759                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDVOXEL HEARTPRO SOFTWARE APPLICATION
MEDVOXEL SYSTEMS INC              510(k) NO: K103565(TRADITIONAL)
ATTN: BONNIE  SEWLOCHAN           PHONE NO : 647 234 6643
2867 CROSSCURRENT DRIVE           SE DECISION MADE: 12-APR-11
MISSISSAUGA    CA L5N 6L1         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,
KAT IMPLANTS, LLC                 510(k) NO: K101201(TRADITIONAL)
ATTN: VITALI  BONDAR              PHONE NO : 603 427 0084   
15 RYE STREET SUITE 115           SE DECISION MADE: 13-APR-11
PORTSMOUTH NH 03801               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVA TPN BAG
VALMED S.R.L.                     510(k) NO: K101412(TRADITIONAL)
ATTN: WALTER  SVANOSIO            PHONE NO : 390 342 052382
VIA PROVINCIALE 10                SE DECISION MADE: 13-APR-11
MAZZO DI VALTELLINA SO    IT I 230510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MPS450 MULTIPARAMETER SIMULATOR
FLUKE BIOMEDICAL                  510(k) NO: K103336(TRADITIONAL)
ATTN: JOHN  NELSON                PHONE NO : 440 498 2579   
6045 COCHRAN RD.                  SE DECISION MADE: 13-APR-11
SOLON OH 44139                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ONESTEP ADULT MULTI-FUNCTION ELECTRODE
ZOLL MEDICAL CORPORATION          510(k) NO: K110742(SPECIAL)
ATTN: ROBERT  MORSE               PHONE NO : 866 639 0060   
525 NARRAGANSETT PARK DRIVE       SE DECISION MADE: 13-APR-11
PAWTUCKET RI 02861                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DBX DEMINERALIZED BONE MATRIX PUTTY
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K103795(TRADITIONAL)
ATTN: NANCY  JOY                  PHONE NO : 732 661 2381   
125 MAY STREET                    SE DECISION MADE: 13-APR-11
EDISON NJ 08837                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DBX DEMINERALIZED BONE MATRIX PUTTY
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K103784(TRADITIONAL)
ATTN: NANCY  JOY                  PHONE NO : 732 661 2381   
125 MAY STREET                    SE DECISION MADE: 13-APR-11
EDISON NJ 08837                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARCHITEX SPACE MAINTENANCE SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K110259(TRADITIONAL)
ATTN: KELLY  DAVIDSON             PHONE NO : 901 399 3035   
1800 PYRAMID PLACE                SE DECISION MADE: 13-APR-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ODRC-DYNAMIC HIP SCREW SYSTEM
ORTHOPAEDIC DEVICE RESEARCH CENTER510(k) NO: K103015(TRADITIONAL)
ATTN: CHENG-KUNG  CHENG           PHONE NO : 886 228 267020
NO. 155, SEC. 2 LI-NUNG STREET    SE DECISION MADE: 13-APR-11
TAIPEI    TW 112                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)
IVOCLAR VIVADENT, INC.            510(k) NO: K103556(TRADITIONAL)
ATTN: DONNA MARIE  HARTNETT       PHONE NO : 716 691 0010   
175 PINEVIEW DR.                  SE DECISION MADE: 13-APR-11
AMHERST NY 14228                  510(k) STATEMENT

DEVICE: NEWDEAL COMPRESSION PLATES
NEWDEAL SAS                       510(k) NO: K093914(TRADITIONAL)
ATTN: STEPHEN  BEIER              PHONE NO : 609 936 5436   
311 ENTERPRISE DR.                SE DECISION MADE: 14-APR-11
PLAINSBORO NJ 08536               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE
3M COMPANY CORP                   510(k) NO: K101468(TRADITIONAL)
ATTN: LINDA  JOHNSON              PHONE NO : 651 737 4376   
3M CENTER, BLDG 275-5W-06         SE DECISION MADE: 14-APR-11
ST. PAUL MN 55144 1000            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KELYNIAM CUSTOM SKULL IMPLANT (CSI)
KELYNIAM GLOBAL, INC              510(k) NO: K103582(TRADITIONAL)
ATTN: JAMES  KETNER               PHONE NO : 860 832 9331   
200 MYRTLE STREET 2ND FLOOR       SE DECISION MADE: 14-APR-11
NEW BRITAIN CT 06053              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
SHIJIAZHUANG GLORY PLASTIC CO., LT510(k) NO: K102085(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 86 10 82387441
# 209 BEI SI HUAN ZHONG ROAD RM 16SE DECISION MADE: 14-APR-11
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VICOR PD2I ANALYZER
VICOR TECHNOLOGIES, INC.          510(k) NO: K101867(TRADITIONAL)
ATTN: GLEN  PARK                  PHONE NO : 212 681 2100   
261 MADISON AVE. 24TH FLOOR       SE DECISION MADE: 14-APR-11
NEW YORK NY 10016                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
SMITH & NEPHEW, INC.              510(k) NO: K110240(SPECIAL)
ATTN: SHEREEN  MYERS              PHONE NO : 901 399 6325   
1450 EAST BROOKS RD.              SE DECISION MADE: 14-APR-11
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
NOVABONE PRODUCTS, LLC            510(k) NO: K110368(SPECIAL)
ATTN: DAVID M GAISSER             PHONE NO : 386 462 7661   
13631 PROGRESS BLVD SUITE 600     SE DECISION MADE: 14-APR-11
ALACHUA FL 32615                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K110887(SPECIAL)
ATTN: ASHLEY  PYLE                PHONE NO : 508 683 4359   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 14-APR-11
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVERCROSS 0.035" OTW PTA DILATATION CATHETER
EV3 INC                           510(k) NO: K110319(SPECIAL)
ATTN: PAULA  CORDERO              PHONE NO : 763 398 7344   
3033 CAMPUS DRIVE                 SE DECISION MADE: 14-APR-11
PLYMOUTH MN 55441                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APNEA RISK EVALUATION SYSTEM (ARES)
ADVANCED BRAIN MONITORING INC.    510(k) NO: K110705(SPECIAL)
ATTN: ADRIENNE  LENZ              PHONE NO : 262 290 0023   
2511 FOX RIVER CIRCLE             SE DECISION MADE: 14-APR-11
WAUKESHA WI 53189                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE ENDOMETRIAL SUCTION CURETTE
JIANGSU SUYUN MEDICAL MATERIALS CO510(k) NO: K102847(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 164 264467
P.O. BOX 237-023                  SE DECISION MADE: 14-APR-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTERTRAK LOGIC PSC TIBIAL INSERT
EXACTECH SARASOTA                 510(k) NO: K110547(SPECIAL)
ATTN: PATRICK  HUGHES             PHONE NO : 352 377 1140   
2320 NW 66TH COURT                SE DECISION MADE: 14-APR-11
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM
REVERSE MEDICAL CORPORATION       510(k) NO: K102418(TRADITIONAL)
ATTN: AMY  ESKINA                 PHONE NO : 949 215 0600   
13900 ALTON PARKWAY SUITE 123     SE DECISION MADE: 15-APR-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER
TANITA CORP.                      510(k) NO: K100183(TRADITIONAL)
ATTN: TOSHISHIKO  ISHIKAWA        PHONE NO : 847 640 9241   
2625 SOUTH CLEARBROOK DRIVE       SE DECISION MADE: 15-APR-11
ARLINGTON HEIGHTS IL 60005        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LANX SPINAL FIXATION SYSTEM
LANX, INC.                        510(k) NO: K103091(SPECIAL)
ATTN: ANDREW  LAMBORNE            PHONE NO : 303 443 7500   
390 INTERLOCKEN CRESCENT SUITE 890SE DECISION MADE: 15-APR-11
BROOMFIELD CO 80021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANGIOSCULPT PTA SCORING BALLOON CATHETER
ANGIOSCORE, INC.                  510(k) NO: K110767(SPECIAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202 637 5794   
555 THIRTEENTH STREET NW          SE DECISION MADE: 15-APR-11
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
INTERNATIONAL BIOMEDICAL, LTD.    510(k) NO: K103527(SPECIAL)
ATTN: AMY  PIEPER                 PHONE NO : 512 873 0033   
8508 CROSS PARK DR.               SE DECISION MADE: 15-APR-11
AUSTIN TX 78754                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
INTERNATIONAL BIOMEDICAL, LTD.    510(k) NO: K103524(SPECIAL)
ATTN: AMY  PIEPER                 PHONE NO : 512 873 0033   
8508 CROSS PARK DR.               SE DECISION MADE: 15-APR-11
AUSTIN TX 78754                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER
SHANTOU I NSTITUTE OF ULTRASONIC I510(k) NO: K110841(SPECIAL)
ATTN: FLOWER  CAI                 PHONE NO : 867 548 8250150
77 JINSHA ROAD                    SE DECISION MADE: 15-APR-11
SHANTOU, GUANGDONG    CH 515041   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS
SPSMEDICAL SUPPLY CORP.           510(k) NO: K110152(TRADITIONAL)
ATTN: GARY J SOCOLA               PHONE NO : 585 359 0130   
6789 WEST HENRIETTA RD            SE DECISION MADE: 15-APR-11
RUSH NY 14543                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
CARDINAL HEALTH, INC.             510(k) NO: K110921(TRADITIONAL)
ATTN: TATYANA  BOGDAN             PHONE NO : 847 887 2325   
1430 WAUKEGAN ROAD                SE DECISION MADE: 15-APR-11
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ATMOS E 201 THORAX AND ATMOS S 201 THORAX
ATMOS INC.                        510(k) NO: K103042(TRADITIONAL)
ATTN: MARCO  SCHLEGEL             PHONE NO : 610 740 1011   
3717 HUCKLEBERRY ROAD             SE DECISION MADE: 15-APR-11
ALLENTOWN PA 18104                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI
ZIMMER, INC.                      510(k) NO: K103662(SPECIAL)
ATTN: REBECCA  BROOKS             PHONE NO : 574 371 8033   
P.O. BOX 708                      SE DECISION MADE: 15-APR-11
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTISTE SOLUTION WITH SYS_VB50 UPDATE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K103606(TRADITIONAL)
ATTN: CHRISTINE  DUNBAR           PHONE NO : 925 602 8157   
4040 NELSON AVE.                  SE DECISION MADE: 15-APR-11
CONCORD CA 94520                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K100344(TRADITIONAL)
ATTN: ROSE  MARINELLI             PHONE NO : 302 631 8805   
MS 514, PO BOX 6101               SE DECISION MADE: 18-APR-11
NEWARK DE 19714 6101              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFILL INTERVERTEBRAL BODY FUSION DEVICE
PINNACLE SPINE GROUP, LLC         510(k) NO: K103729(TRADITIONAL)
ATTN: REBECCA K PINE              PHONE NO : 760 809 5178   
1601 ELM STREET, SUITE 300        SE DECISION MADE: 18-APR-11
DALLAS TX 75201                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AOI CRANIAL HELMET
ADVANCED ORTHOPRO INC.            510(k) NO: K103362(TRADITIONAL)
ATTN: MOHAMAD  MANSOORI           PHONE NO : 317 924 4444   
1820 N. ILLINOIS ST.              SE DECISION MADE: 18-APR-11
INDIANAPOLIS IN 46202             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESPICHAMBER VALVED HOLDING CHAMBER
TRUDELL MEDICAL INTL.             510(k) NO: K110136(TRADITIONAL)
ATTN: DARRYL  FISHER              PHONE NO : 519 455 7060
725 THIRD ST.                     SE DECISION MADE: 18-APR-11
LONDON, ONTARIO    CA N5V 5G4     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS
GE MEDICAL SYSTEMS, LLC           510(k) NO: K093581(TRADITIONAL)
ATTN: TRACEY  ORTIZ               PHONE NO : 414 544 3026   
3000 N GRANDVIEW BLVD.            SE DECISION MADE: 19-APR-11
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WEXLER VASCULAR CLAMP SERIES
MICROSURGICAL LABORATORIES,INC.DBA510(k) NO: K110148(TRADITIONAL)
ATTN: LISA S JONES                PHONE NO : 713 664 6775   
540 COLLEGE STREET                SE DECISION MADE: 19-APR-11
BELLAIRE TX 77401                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONSERVE BIO FOAM SHELL
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K110029(TRADITIONAL)
ATTN: DANIELLE  MUELLER           PHONE NO : 901 290 5904   
5677 AIRLINE ROAD                 SE DECISION MADE: 19-APR-11
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA
JIEYING LABORATORY INC.           510(k) NO: K102480(TRADITIONAL)
ATTN: GRACE  HOLLAND              PHONE NO : 949 262 0411   
9722 AVE. SAUSALITO               SE DECISION MADE: 19-APR-11
IRVINE CA 92606                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES
WEALTH ON (JIANGSU) CO., LTD      510(k) NO: K110219(TRADITIONAL)
ATTN: CHENGYU  SHEN               PHONE NO : 608 217 9358   
5 CAREY STREET                    SE DECISION MADE: 19-APR-11
PENNINGTON NJ 08534               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
ZIBO YUECHUAN PLASTIC PRODUCTS CO.510(k) NO: K110338(TRADITIONAL)
ATTN: FRANK  LIU                  PHONE NO : 909 548 4828   
12390 EAST END AVENUE             SE DECISION MADE: 19-APR-11
CHINO CA 91710                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPACELABS SMART DISCLOSURE SYSTEM
SPACELABS HEALTHCARE              510(k) NO: K110779(SPECIAL)
ATTN: THOMAS  KROENKE             PHONE NO : 303 956 4232   
P.O. BOX 3018                     SE DECISION MADE: 19-APR-11
NEDERLAND CO 80466                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVERON CENTRAL DISPLAY STATION (CDS)
EARLYSENSE LTD.                   510(k) NO: K110521(SPECIAL)
ATTN: DALIA  ARGAMAN              PHONE NO : 972 375 22330X160
TZVI 12                           SE DECISION MADE: 19-APR-11
RAMAT-GAN    IS 52504             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NATUS SLEEPWORKS, MODEL 104017
EXCEL-TECH LTD. (XLTEK)           510(k) NO: K090277(TRADITIONAL)
ATTN: GOLDY  SINGH                PHONE NO : 905 829 5300
2568 BRISTOL CIR.                 SE DECISION MADE: 19-APR-11
OAKVILLE, ONTARIO    CA L6H 5S1   510(k) STATEMENT

DEVICE: PARIETEX OPTIMIZED COMPOSTIE MESH
SOFRADIM PRODUCTION               510(k) NO: K110815(SPECIAL)
ATTN: JAMES  MCMAHON              PHONE NO : 781 839 1787   
BIOSURGERY 15 CROSBY DRIVE        SE DECISION MADE: 19-APR-11
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)
SOFRADIM PRODUCTION               510(k) NO: K110816(SPECIAL)
ATTN: JAMES  MCMAHON              PHONE NO : 781 839 1787   
BIOSURGERY 15 CROSBY DRIVE        SE DECISION MADE: 19-APR-11
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER
3M COMPANY-3M HEALTH CARE         510(k) NO: K103277(TRADITIONAL)
ATTN: SUZANNE  LEUNG              PHONE NO : 651 575 8052   
3M CENTER, BLDG.  275-5W-06       SE DECISION MADE: 19-APR-11
ST. PAUL MN 55133 1006            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRIXEL CO2 LASER
BEIJING SYNTECH LASER CO., LTD.   510(k) NO: K110434(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 122 815850
P.O. BOX 237-023                  SE DECISION MADE: 19-APR-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: FLEXIBLE CARDIAC COIL
LBDS HOLDING COMPANY              510(k) NO: K110487(TRADITIONAL)
ATTN: RICHARD  BRYANT             PHONE NO : 214 564 0146   
6440 SKY POINTE DR SUITE 140      SE DECISION MADE: 19-APR-11
LAS VEGAS NV 89131                510(k) STATEMENT

DEVICE: BLUE SKY BIO DENTAL IMPLANT SYSTEM
BLUE SKY BIO, LLC                 510(k) NO: K102034(TRADITIONAL)
ATTN: ALBERT  ZICKMANN            PHONE NO : 847 548 8499   
888 E BELVIDERE RD. SUITE 212     SE DECISION MADE: 19-APR-11
GRAYSLAKE IL 60030                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FDI GLUCOSE CONTROL SOLUTION FOR AVIVA
FUJIREBIO DIAGNOSTICS, INC        510(k) NO: K110436(TRADITIONAL)
ATTN: KENT  PRUETT                PHONE NO : 830 372 1391   
940 CROSSROADS BLVD.              SE DECISION MADE: 20-APR-11
SEGUIN TX 78155                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPUTED DENTAL RADIOGRAPHY
SCHICK TECHNOLOGIES, INC.         510(k) NO: K110768(SPECIAL)
ATTN: SCOTT  DOYLE                PHONE NO : 718 937 5765   
30-30 47TH AVE.                   SE DECISION MADE: 20-APR-11
LONG ISLAND CITY NY 11101         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLE
RONGSHAN LI                       510(k) NO: K110112(TRADITIONAL)
ATTN: RONGSHAN  LI                PHONE NO : 414 241 1022   
11 GEORGETOWN CT.                 SE DECISION MADE: 20-APR-11
BASKING RIDGE NJ 07920            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UCP DRUG SCREENING TEST CUPS
UCP BIOSCIENCES, INC.             510(k) NO: K110515(SPECIAL)
ATTN: NANCY  CHEN                 PHONE NO : 408 392 0064   
1445 KOLL CIRCLE, STE. 111        SE DECISION MADE: 20-APR-11
SAN JOSE CA 95112                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRE BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K110833(SPECIAL)
ATTN: JANIS  TARANTO              PHONE NO : 508 683 4560   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 20-APR-11
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPI TITANIUM BASE FOR CAD/CAM
THOMMEN MEDICAL, AG               510(k) NO: K102804(TRADITIONAL)
ATTN: LINDA K SCHULZ              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL, SUITE 200   SE DECISION MADE: 20-APR-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,
UNILENS CORP., USA                510(k) NO: K110452(SPECIAL)
ATTN: ALAN J FRAZER               PHONE NO : 727 544 2531   
10431 72ND ST. NORTH              SE DECISION MADE: 20-APR-11
LARGO FL 33777                    510(k) STATEMENT

DEVICE: SATURN 8000-GS
NEW MEDICAL CO., LTD.             510(k) NO: K110210(TRADITIONAL)
ATTN: JUN-HSIUNG  LIN             PHONE NO : 909 244 6562   
1460 ATTERBURY DR.                SE DECISION MADE: 20-APR-11
WALNUT CA 91789                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYMBIA.NET
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K110844(SPECIAL)
ATTN: ELAINE  CHANG               PHONE NO : 847 304 7516   
2501 NORTH BARRINGTON RD.         SE DECISION MADE: 20-APR-11
HOFFMAN ESTATES IL 60192          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESUSCITATION UNIT 105
ATOM MEDICAL CORPORATION          510(k) NO: K103317(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 20-APR-11
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM
PATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K110626(SPECIAL)
ATTN: BRIAN  CLEARY               PHONE NO : 425 636 4079   
10801 120TH AVENUE NE             SE DECISION MADE: 20-APR-11
KIRKLAND WA 98033                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEOPIP PATIENT CIRCUIT WITH PEEP
NEOFORCE GROUP, INC.              510(k) NO: K103833(TRADITIONAL)
ATTN: MONICA  FERRANTE            PHONE NO : 215 672 6800   
35 COMMERCE DR.                   SE DECISION MADE: 20-APR-11
IVYLAND PA 18974                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RETCAM 3 OPTHALMIC IMAGING SYSTEM
CLARITY MEDICAL SYSTEMS           510(k) NO: K102859(TRADITIONAL)
ATTN: GARY A SEEGER               PHONE NO : 925 463 7984   
5775 WEST LAS POSITAS BLVD. SUITE SE DECISION MADE: 20-APR-11
PLEASANTON CA 94588 4084          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEOSCAF
TEXAS INNOVATIVE MEDICAL DEVICES (510(k) NO: K101827(TRADITIONAL)
ATTN: JERRY  CHANG                PHONE NO : 352 256 2707   
4808 RESEARCH DRIVE               SE DECISION MADE: 20-APR-11
SAN ANTONIO TX 78240              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SELECTRA CS LEAD INTRODUCER SYSTEM
BIOTRONIK, INC.                   510(k) NO: K110461(SPECIAL)
ATTN: JON  BRUMBAUGH              PHONE NO : 888 345 0374   
6024 JEAN ROAD                    SE DECISION MADE: 20-APR-11
LAKE OSWEGO OR 97035              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM
MEDLINE INDUSTRIES, INC.          510(k) NO: K103602(TRADITIONAL)
ATTN: MATT  CLAUSEN               PHONE NO : 847 643 4785   
ONE MEDLINE PLACE                 SE DECISION MADE: 21-APR-11
MUNDELEIN IL 60060 4486           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
SYNTHES USA                       510(k) NO: K110125(TRADITIONAL)
ATTN: CHRISTOPHER  HACK, ESQ.     PHONE NO : 610 719 6940   
1301 GOSHEN PKWY                  SE DECISION MADE: 21-APR-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)
ORTHOGEM LIMITED                  510(k) NO: K110787(SPECIAL)
ATTN: WE-JEN  LO                  PHONE NO : 441 159 505721
BIOCITY, PENNYFOOT STREET         SE DECISION MADE: 21-APR-11
NOTTINGHAM    UK NG1 1GF          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HELENA SYSTEM
ROYAL OAK MEDICAL DEVICES         510(k) NO: K110177(TRADITIONAL)
ATTN: MATTHEW  KROLL              PHONE NO : 248 628 2830   
39533 WOODWARD AVENUE             SE DECISION MADE: 21-APR-11
BLOOMFIELD HILLS MI 48304         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IFUSE IMPLANT SYSTEM
SI-BONE, INC.                     510(k) NO: K110838(SPECIAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET STREET 29TH FLOOR     SE DECISION MADE: 21-APR-11
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM
INTRA-LOCK INTERNATIONAL, INC.    510(k) NO: K103194(ABBREVIATED)
ATTN: ANGELA  BLACKWELL           PHONE NO : 704 450 9934   
6560 WEST ROGERS CIRCLE           SE DECISION MADE: 21-APR-11
BOCA RATON FL 33487               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BODYFLOW P2CH
PHYSIOMED ELEKTROMEDIZIN AG       510(k) NO: K100862(TRADITIONAL)
ATTN: BIRGIT  SCHMID              PHONE NO : 499 126 258717
HUTWEIDE 10                       SE DECISION MADE: 21-APR-11
SCHNAITTACH/LAIPERSDORF    GM D-91510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CURVE IMAGE
CURVE DENTAL, INC.                510(k) NO: K110139(TRADITIONAL)
ATTN: CAROLINE  TONTINI           PHONE NO : 512 327 9997   
611 WEST 5TH STREET, THIRD FLOOR  SE DECISION MADE: 21-APR-11
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0
CEPHEID                           510(k) NO: K103766(TRADITIONAL)
ATTN: KERRY J FLOM                PHONE NO : 408 400 8460   
904 CARIBBEAN DRIVE               SE DECISION MADE: 21-APR-11
SUNNYVALE CA 94089 1189           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JETPACK 2.0
PHILIPS MEDICAL SYSTEMS (CLEVELAND510(k) NO: K111024(TRADITIONAL)
ATTN: LORI R PETERSON             PHONE NO : 408 468 3042   
3860 NORTH 1ST STREET             SE DECISION MADE: 21-APR-11
SAN JOSE CA 95134                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EASYRA UREA NITROGEN AND CREATININE REAGENTS
MEDICA CORP.                      510(k) NO: K110675(TRADITIONAL)
ATTN: PHOTIOS  MAKRIS             PHONE NO : 781 541 7443   
5 OAK PARK DRIVE                  SE DECISION MADE: 21-APR-11
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRECISION LIQUID OXYGEN SYSTEM
PRECISION MEDICAL, INC.           510(k) NO: K103324(TRADITIONAL)
ATTN: JAMES  PARKER               PHONE NO : 610 262 6090   
300 HELD DRIVE                    SE DECISION MADE: 21-APR-11
NORTHAMPTON PA 18067              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL
SYNTEX HEALTHCARE PRODUCTS CO., LT510(k) NO: K103770(TRADITIONAL)
ATTN: KATHY  LIU                  PHONE NO : 909 590 1611   
3973 SCHAEFER AVE                 SE DECISION MADE: 21-APR-11
CHINO CA 91710                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GSP NEONATAL THYROXINE (T4)
WALLAC OY, A SUBSIDIARY OF PERKINE510(k) NO: K103484(TRADITIONAL)
ATTN: SUSAN K HAMANN              PHONE NO : 781 663 5872   
940 WINTER STREET                 SE DECISION MADE: 22-APR-11
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: C.T.M. MOBILITY SCOOTER HS515(3W)
C.T.M. HOMECARE PRODUCT, INC.     510(k) NO: K110567(TRADITIONAL)
ATTN: SHEILA  RAMERMAN            PHONE NO : 541 683 3017   
927 THRONE DRIVE                  SE DECISION MADE: 22-APR-11
EUGENE OR 97402                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENX REVOLUTION
VENX LLC                          510(k) NO: K110355(TRADITIONAL)
ATTN: IRA  DUESLER                PHONE NO : 315 868 5645   
4700 S. OVERLAND DRIVE            SE DECISION MADE: 22-APR-11
TUCSON' AZ 85714                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: C.T.M. MOBILITY SCOOTER - MODEL HS 118
C.T.M. HOMECARE PRODUCT, INC.     510(k) NO: K110395(TRADITIONAL)
ATTN: SHEILA  RAMERMAN            PHONE NO : 541 683 3017   
927 THRONE DRIVE                  SE DECISION MADE: 22-APR-11
EUGENE OR 97402                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVISION PROTHESIS
SMITH & NEPHEW, INC.              510(k) NO: K110837(SPECIAL)
ATTN: MEGAN  BEVILL               PHONE NO : 901 399 5340   
1450 EAST BROOKS RD.              SE DECISION MADE: 22-APR-11
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WINCO STRETCHAIR
WINCO MFG., LLC                   510(k) NO: K110671(TRADITIONAL)
ATTN: JIM  ANKOVIAK               PHONE NO : 352 854 2929   
5516 SW 1st Ln                    SE DECISION MADE: 22-APR-11
Ocala FL 34474                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR
RUBBERCARE PROTECTION PRODUCTS (M)510(k) NO: K102902(TRADITIONAL)
ATTN: LIM  KWEE SHYAN             PHONE NO : 606 677 2781
OFF JALAN SENAWANG EMPAT SENAWANG SE DECISION MADE: 22-APR-11
SEREMBAN, NEGERI SEMBILAN    MY 70510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POSEY BED
J. T. POSEY CO.                   510(k) NO: K103817(TRADITIONAL)
ATTN: ROBERT  KELLEHER            PHONE NO : 626 454 2109   
5635 PECK RD.                     SE DECISION MADE: 22-APR-11
ARCADIA CA 91006                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVS ANCHOR-C CERVICAL CAGE SYSTEM
STRYKER SPINE                     510(k) NO: K102606(TRADITIONAL)
ATTN: KIMBERLY  LANE              PHONE NO : 201 760 8215   
2 PEARL COURT                     SE DECISION MADE: 22-APR-11
ALLENDALE NJ 07401 1677           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INVADER MTHFR 1298
HOLOGIC, INC.                     510(k) NO: K100496(TRADITIONAL)
ATTN: RANDALL J COVILL            PHONE NO : 508 263 8853   
250 CAMPUS DRIVE                  SE DECISION MADE: 25-APR-11
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROTECTIVE RESTRAINT
MEDI-TECH INTL. CORP.             510(k) NO: K110377(TRADITIONAL)
ATTN: MARILYN  GEIGER             PHONE NO : 414 570 8880   
26 COURT ST., SUITE 1301          SE DECISION MADE: 25-APR-11
BROOKLYN NY 11242                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLCART B
B. BRAUN AVITUM AG                510(k) NO: K102194(TRADITIONAL)
ATTN: ANGELA  CARAVELLA           PHONE NO : 610 266 0500   
901 MARCON BLVD.                  SE DECISION MADE: 25-APR-11
ALLENTOWN PA 18109                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VAPRO PLUS INTERMITTENT CATHETER
HOLLISTER, INCORPORATED           510(k) NO: K110862(SPECIAL)
ATTN: CHRIS  STUKEL               PHONE NO : 847 918 3452   
2000 HOLLISTER DRIVE              SE DECISION MADE: 26-APR-11
;IBERTYVILLE IL 60048             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVAKONE SPHERICAL AND TORIC LENSES
ALDEN OPTICAL LABS., INC.         510(k) NO: K102557(TRADITIONAL)
ATTN: CHARLES H CREIGHTON         PHONE NO : 716 937 9181   
13295 BROADWAY                    SE DECISION MADE: 26-APR-11
ALDEN NY 14004                    510(k) STATEMENT

DEVICE: AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION
GE HEALTHCARE                     510(k) NO: K110834(SPECIAL)
ATTN: HELEN  PENG                 PHONE NO : 262 548 5091   
3000 NORTH.GRANDVIEW BLVD. W1140  SE DECISION MADE: 26-APR-11
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZEUS ELISA HSV GC-I IGG TEST SYSTEM
ZEUS SCIENTIFIC, INC.             510(k) NO: K103363(TRADITIONAL)
ATTN: EWA  NADOLCZAK              PHONE NO : 908 526 3744   
200 EVANS WAY                     SE DECISION MADE: 26-APR-11
BRANCHBURG NJ 08876               510(k) STATEMENT

DEVICE: DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
EDAN INSTRUMENTS, INC.            510(k) NO: K110999(TRADITIONAL)
ATTN: RANDY  JIANG                PHONE NO : 867 552 6858736
4/F, NEW ENERGY BLDG., 2009 NANYOUSE DECISION MADE: 26-APR-11
NANSHAN, GUANGDONG    CH 518054   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DISPOSABLE INSULIN SYRINGE
WENZHOU WUZHOU IMPORT & EXPORT CO.510(k) NO: K110421(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 164 264467
P.O. BOX 237-023                  SE DECISION MADE: 26-APR-11
BINGYI XIANG, ZHEJIANG    CH 32500510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRESTODR 4143
CMT MEDICAL TECHNOLOGIES, LTD.    510(k) NO: K110849(SPECIAL)
ATTN: SHLOMI  DINES               PHONE NO : 972 485 66220
INDUSTRIAL PARK P.O.B. 111        SE DECISION MADE: 26-APR-11
YOQNEAM ILIT    IS 20692          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPELLA CONTROLLER WITH FLOW CONTROL
ABIOMED, INC.                     510(k) NO: K110845(SPECIAL)
ATTN: ROBERT  STEWART             PHONE NO : 978 646 1567   
22 CHERRY HILL DR.                SE DECISION MADE: 27-APR-11
DANVERS MA 01923                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIVERSAL DIGITAL INTERFACE (UDI) 1717
MERIDIAN MEDICAL SYSTEMS, LLC     510(k) NO: K103599(TRADITIONAL)
ATTN: ARIEL  MARCIANO             PHONE NO : 407 719 9853   
325 HARRIS DRIVE                  SE DECISION MADE: 27-APR-11
AURORA OH 44202                   510(k) STATEMENT

DEVICE: AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
TORNIER, INC.                     510(k) NO: K110865(SPECIAL)
ATTN: BRAHIM  HADRI               PHONE NO : 978 232 9997   
100 CUMMINGS CENTER, SUITE 444C   SE DECISION MADE: 27-APR-11
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRIPLEX ER. YAG / ND: YAG SYSTEM
SANDSTONE MEDICAL TECHNOLOGIES, LL510(k) NO: K110502(TRADITIONAL)
ATTN: MARK  ROHRER                PHONE NO : 205 290 8251   
105 CITATION COURT                SE DECISION MADE: 27-APR-11
HOMEWOOD AL 35209                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES
HEBEI TENGDA PLASTIC CO., LTD     510(k) NO: K102151(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
ROOM 1606 BLDG.1 JIANXIANG YUA NO.SE DECISION MADE: 27-APR-11
SHIJIAZHUANG    CH 100083         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FILMARRAY RP PANEL
IDAHO TECHNOLOGY, INC.            510(k) NO: K110764(TRADITIONAL)
ATTN: BETH  LINGENFELTER          PHONE NO : 801 736 6354   
390 WAKARA WAY                    SE DECISION MADE: 27-APR-11
SALT LAKE CITY UT 84108           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
SOLARC SYSTEMS INC.               510(k) NO: K103204(TRADITIONAL)
ATTN: BRUCE  ELLIOTT              PHONE NO : 705 739 3048
1515 SNOW VALLEY ROAD             SE DECISION MADE: 27-APR-11
MINESING,ONTARIO    CA L0L 1Y3    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CUBESCAN / BIOCON-700
MCUBE TECHNOLOGY CO., LTD.        510(k) NO: K111021(TRADITIONAL)
ATTN: SEUNGTAI  KIM               PHONE NO : 822 342 17780
803 SHINNAE-TECHNOTOWN 485 SANGBONSE DECISION MADE: 27-APR-11
CHUNGNANG-KU, SEOUL    KS 131-220 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
BECKMAN COULTER, INC.             510(k) NO: K103842(TRADITIONAL)
ATTN: MARINE  BOYAJIAN            PHONE NO : 714 961 6536   
250 S. KRAEMER BOULEVARD MAIL STOPSE DECISION MADE: 27-APR-11
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGHTY DD INFUSION SET
MEDX-SET LTD                      510(k) NO: K110282(TRADITIONAL)
ATTN: RAYMOND  KELLY              PHONE NO : 603 595 0095   
56B SHAWDOW DR.                   SE DECISION MADE: 27-APR-11
HUDSON NH 03051                   510(k) STATEMENT

DEVICE: TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS
THUNDER TIGER CORP.               510(k) NO: K102517(TRADITIONAL)
ATTN: JO  LEE                     PHONE NO : 886 423 591616
NO. 7, 6TH ROAD INDUSTRY PARK     SE DECISION MADE: 27-APR-11
TAICHUNG    TW 40755              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
DIAZYME LABORATORIES              510(k) NO: K103557(TRADITIONAL)
ATTN: ABHIJIT  DATTA              PHONE NO : 858 455 4762   
12889 GREGG COURT                 SE DECISION MADE: 27-APR-11
POWAY CA 92064                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PCL TIGHTROPE
ARTHREX, INC.                     510(k) NO: K110123(TRADITIONAL)
ATTN: COURTNEY  SMITH             PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 28-APR-11
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP
APEX BIOTECHNOLOGY CORP.          510(k) NO: K102481(SPECIAL)
ATTN: LISA  LIU                   PHONE NO : 866 356 41952
NO. 7, LI-HSIN ROAD V, HSINCHU SCISE DECISION MADE: 28-APR-11
HSINCHU    TW 30078               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FEMVUE SALINE-AIR DEVICE
FEMASYS INC.                      510(k) NO: K110288(TRADITIONAL)
ATTN: LISA  PEACOCK               PHONE NO : 770 500 3910   
5000 RESEARCH COURT STE .100      SE DECISION MADE: 28-APR-11
SUWANEE GA 30024                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10
MICROVENTION, INC.                510(k) NO: K103758(SPECIAL)
ATTN: LARAINE  PANGELINA          PHONE NO : 714 247 8150   
1311 VALENCIA AVE                 SE DECISION MADE: 28-APR-11
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
HEBEI TENGDA PLASTIC CO., LTD     510(k) NO: K102152(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
ROOM 1606 BLDG.1 JIANXIANG YUA NO.SE DECISION MADE: 28-APR-11
SHIJIAZHUANG    CH 100083         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD PEN NEEDLE
BECTON DICKINSON AND COMPANY (BD) 510(k) NO: K110105(SPECIAL)
ATTN: PASQUALE  AMATO             PHONE NO : 201 847 4513   
1 BECTON DRIVE. MC372             SE DECISION MADE: 28-APR-11
FRANKLIN LAKES NJ 07417 1885      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ONE DAY FLAT PACK
MENICON CO. LTD.                  510(k) NO: K102895(TRADITIONAL)
ATTN: MARTIN  DALSING             PHONE NO : 970 243 5490   
806 KIMBALL AVENUE                SE DECISION MADE: 28-APR-11
GRAND JUNCTION CO 81501           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMARC FIDUCIAL MARKER
CARBON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K110772(TRADITIONAL)
ATTN: ANDREW J ADAMS              PHONE NO : 651 653 8512   
1290 HAMMOND RD.                  SE DECISION MADE: 28-APR-11
ST. PAUL MN 55110 5867            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENAISSANCE SYSTEM
MAZOR ROBOTICS LTD                510(k) NO: K110911(SPECIAL)
ATTN: AHAVA  STEIN                PHONE NO : 972 976 70002
20 HATA'AS ST.                    SE DECISION MADE: 28-APR-11
KFAR SABA    IS 44425             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPECTRA LASER SYSTEM
LUTRONIC CORPORATION              510(k) NO: K103455(SPECIAL)
ATTN: JHUNG  WON VOJIR            PHONE NO : 609 275 1565   
51 EVERETT DRIVE, UNIT A-50       SE DECISION MADE: 28-APR-11
PRINCETON JUNCTION NJ 08550       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K103683(ABBREVIATED)
ATTN: GARO  MIMARYAN              PHONE NO : 914 524 3270   
511 BENEDICT AVENUE               SE DECISION MADE: 28-APR-11
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
R & D SYSTEMS, INC.               510(k) NO: K101578(TRADITIONAL)
ATTN: NANCY  RING                 PHONE NO : 612 656 4533   
614 MCKINLEY PL., N.E.            SE DECISION MADE: 28-APR-11
MINNEAPOLIS MN 55413              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CUTTING EDGE SPINE INTERBODY FUSION DEVICE
CUTTING EDGE SPINE, LLC           510(k) NO: K102957(TRADITIONAL)
ATTN: JOHN  KAPITAN               PHONE NO : 704 843 7852   
100 E. SOUTH MAIN STREET PO BOX 14SE DECISION MADE: 28-APR-11
MATTHEWS NC 28173                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AGACHAMBER SPACER
AGAPLASTIC IND. COM. LTDA.        510(k) NO: K101348(TRADITIONAL)
ATTN: MARIA F GRIFFIN             PHONE NO : 704 843 1675   
55 NORTHERN BLVD SUITE 200        SE DECISION MADE: 29-APR-11
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
CHANGDA PLASTIC PRODUCT CO., LTD  510(k) NO: K103196(TRADITIONAL)
ATTN: WANG  LIN                   PHONE NO : 86 310 3096390
WANGZHUANG TOWN, LI COUNTY        SE DECISION MADE: 29-APR-11
HANDAN CITY    CH 056001          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORTROSS BONE VOID FILLER
PIONEER SURGICAL TECHNOLOGY       510(k) NO: K110561(SPECIAL)
ATTN: DAVID J COLLETTE            PHONE NO : 858 792 1235   
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 29-APR-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REUSABLE TEST PACK FOR DANA EMULATING INDICATORS
DANA PRODUCTS, INC.               510(k) NO: K110253(TRADITIONAL)
ATTN: HARRY  BALA                 PHONE NO : 847 455 2881   
7 COREY DR.                       SE DECISION MADE: 29-APR-11
SOUTH BARRINGTON IL 60010         510(k) STATEMENT

DEVICE: KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
KIMBERLY-CLARK CORP.              510(k) NO: K110455(ABBREVIATED)
ATTN: ANN  WATERHOUSE             PHONE NO : 678 352 6719   
1400 HOLCOMB BRIDGE RD.           SE DECISION MADE: 29-APR-11
ROSWELL GA 30076                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW


                                                 TOTAL 510(k)s THIS PERIOD   240                                     
                                                 TOTAL WITH SUMMARIES        226                                     
                                                 TOTAL WITH STATEMENTS        14