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U.S. Department of Health and Human Services

Medical Devices

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January 2011 510(k) Clearances

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


DEVICE: ROUGHRIDER
WHIRLWIND WHEELCHAIR INTERNATIONAL510(k) NO: K103212

(TRADITIONAL)
ATTN: MARC  KRIZACK               PHONE NO : 415 338 6277   
1600 HOLLOWAY AVENUE SCI 251      SE DECISION MADE: 03-JAN-11
SAN FRANCISCO CA 94132            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115
DIADEXUS, INC.                    510(k) NO: K101853

(TRADITIONAL)
ATTN: NINA  PELED                 PHONE NO : 650 246 6486   
343 OYSTER POINT BLVD.            SE DECISION MADE: 03-JAN-11
SOUTH SAN FRANCISCO CA 94080      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DX-D 100
AGFA HEALTHCARE N.V.              510(k) NO: K103597

(TRADITIONAL)
ATTN: PHIL  CUSCUNA               PHONE NO : 416 240 7317   
10 S ACADEMY STREET               SE DECISION MADE: 03-JAN-11
GREENVILLE SC 29601               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 1.5T 16-CHANNEL HAND-WRIST COIL
INVIVO CORPORATION                510(k) NO: K103149

(TRADITIONAL)
ATTN: ELIZABETH  WHEELER          PHONE NO : 352 336 0010   
3545 SW 47TH AVE.                 SE DECISION MADE: 03-JAN-11
GAINESVILLE FL 32608              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KRYSTALRAD 560 (FLAATZ 560)
MEDICATECH USA                    510(k) NO: K102284

(TRADITIONAL)
ATTN: JOHN  ROSS                  PHONE NO : 949 679 2881   
8870 RAVELLO COURT                SE DECISION MADE: 03-JAN-11
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TANDA MAX
PHAROS LIFE CORPORATION           510(k) NO: K103415

(TRADITIONAL)
ATTN: GORDON  WEHNER              PHONE NO : 519 651 1177
11-380 JAMIESON PKWY              SE DECISION MADE: 03-JAN-11
CAMBRIDGE, ONTARIO    CA N3C 4N4  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: I-SEED
THERAGENICS CORP.                 510(k) NO: K103319

(ABBREVIATED)
ATTN: BESTY  CORTELLONI           PHONE NO : 770 831 4294   
5203 BRISTOL INDUSTRIAL WAY       SE DECISION MADE: 03-JAN-11
BUFORD GA 30518                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KRYSTALRAD (ATAL8)
MEDICATECH USA                    510(k) NO: K102285

(TRADITIONAL)
ATTN: JOHN  ROSS                  PHONE NO : 949 679 2881   
8870 RAVELLO COURT                SE DECISION MADE: 03-JAN-11
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUPER CHAIR FOR KIDS BY ORION
FUTURE MOBILITY HEALTHCARE INC.   510(k) NO: K103073

(TRADITIONAL)
ATTN: ABDULSAMAD  PANCHBHAYA      PHONE NO : 905 671 1661
3223 ORLANDO DRIVE                SE DECISION MADE: 03-JAN-11
MISSISSAUGA    CA L4V 1C5         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: F20
TEKNIMED SA                       510(k) NO: K103433(SPECIAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0188   
1001 OAKWOOD BLVD                 SE DECISION MADE: 03-JAN-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERAROOT IMPLANT SYSTEM
ORAL ICEBERG S.L.                 510(k) NO: K093595

(TRADITIONAL)
ATTN: STUART R GOLDMAN            PHONE NO : 512 327 9997   
1705 S. CAPITAL OF TEXAS HWY SUITESE DECISION MADE: 04-JAN-11
AUSTIN TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RADSCAN EQUIPMENT SLICKER
RADSCAN MEDICAL EQUIPMENT, INC.   510(k) NO: K101350

(TRADITIONAL)
ATTN: ORAN R BROWN                PHONE NO : 623 580 0556   
23910 N. 19TH AVE BLDG 2 SUITE    SE DECISION MADE: 04-JAN-11
PHOENIX AZ 85085                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DUAL INCU I
ATOM MEDICAL CORPORATION          510(k) NO: K102226

(TRADITIONAL)
ATTN: TSUYOSHI  SUGINO            PHONE NO : 813 381 53632
3-18-15 HONGO                     SE DECISION MADE: 04-JAN-11
BUNKYO-KU, TOKYO    JA 113-0033   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00
PHILIPS MEDICAL SYSTEMS           510(k) NO: K102974

(TRADITIONAL)
ATTN: GARY  BECKER                PHONE NO : 561 886 5124   
6400 N. CONGRESS AVE. SUITE 1050  SE DECISION MADE: 04-JAN-11
BOCA RATON FL 33487 2810          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: YOBOSHI DENTAL UNIT
FOSHAM YOBOSHI MEDICAL EQUIPMENT C510(k) NO: K103550

(TRADITIONAL)
ATTN: SABRINA  WEI                PHONE NO : 867 558 3089699
ROOM 2706, BLOCK A, ZHONGFANG JINYSE DECISION MADE: 04-JAN-11
SHENZHEN, GUANGDONG    CH 528500  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CONGRUENT BONE PLATE  SYSTEM
ACUMED LLC                        510(k) NO: K102998

(TRADITIONAL)
ATTN: ED  BOEHMER                 PHONE NO : 503 627 9957   
5885 NW CORNELIUS PASS RD.        SE DECISION MADE: 04-JAN-11
HILLSBORO OR 97124 9432           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GAUNYING INFRARED LAMP MODEL IL50
FOSHAN GAUNYING ELECTRONICS CO., L510(k) NO: K101693

(TRADITIONAL)
ATTN: GUENTER  GINSBERG           PHONE NO : 239 948 2001   
11820 RED HIBISCUS DRIVE          SE DECISION MADE: 05-JAN-11
BONITA SPRINGS FL 34135           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTIFIT TOTAL HIP SYSTEM
OTIS BIOTECH CO., LTD             510(k) NO: K101472

(ABBREVIATED)
ATTN: SRINIVASAREDDY  KROTHA      PHONE NO : 82 31 3190406
514, 2-BA BLOCK JEONGWANG-DONG    SE DECISION MADE: 05-JAN-11
SIHEUNG-SI, GYOUNGGI-DO    KS 429-510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY
SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K102544

(TRADITIONAL)
ATTN: KATHLEEN  SOLOMON           PHONE NO : 978 749 1605   
130 FORBES BLVD.                  SE DECISION MADE: 05-JAN-11
MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX TIBIAL GRAFTBOLT
ARTHREX, INC.                     510(k) NO: K103060

(SPECIAL)
ATTN: COURTNEY  SMITH             PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 05-JAN-11
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE
ELLMAN INT'L INC.                 510(k) NO: K102698

(SPECIAL)
ATTN: JONATHAN  ACHENBACH         PHONE NO : 763 257 7125   
3333 ROYAL AVENUE                 SE DECISION MADE: 05-JAN-11
OCEANSIDE NY 11572 3625           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOBUTTON DIRECT
SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K102982

(TRADITIONAL)
ATTN: DEANA  BOUSHELL             PHONE NO : 508 337 4036   
150 MINUTEMAN RD.                 SE DECISION MADE: 05-JAN-11
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES 6.0 COCR AND CPT TI-3 RODS
SYNTHES SPINE                     510(k) NO: K103287

(SPECIAL)
ATTN: ELIZABETH  KIERZEK          PHONE NO : 610 719 5722   
1302 WRIGHTS LANE EAST            SE DECISION MADE: 05-JAN-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM
MEDISON CO., LTD.                 510(k) NO: K103722

(TRADITIONAL)
ATTN: PARK  KYEONG-MI             PHONE NO : 822 219 41381
1003  DAECHI-DONG GANGNAM-GU      SE DECISION MADE: 05-JAN-11
SEOUL    KS 135-280               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: BUILD-IT TOTAL CORE
PENTRON CLINICAL                  510(k) NO: K102703

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

DEVICE: CERETENE SOLUBLE IMPLANT MATERIAL
CEREMED, INC.                     510(k) NO: K103047

(TRADITIONAL)
ATTN: TADEUSZ  WELLISZ            PHONE NO : 310 815 2125   
3643 LENAWEE AVE.                 SE DECISION MADE: 05-JAN-11
LOS ANGELES CA 90016              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS
ALLERGAN MEDICAL                  510(k) NO: K102806

(SPECIAL)
ATTN: MICAH  SCHLOSS              PHONE NO : 805 961 5828   
71 S. LOS CARNEROS ROAD           SE DECISION MADE: 05-JAN-11
GOLETA CA 93117                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
EV3 INC                           510(k) NO: K103618

(TRADITIONAL)
ATTN: BRENDA  JOHNSON             PHONE NO : 763 398 7000   
3033 CAMPUS DRIVE                 SE DECISION MADE: 05-JAN-11
PLYMOUTH MN 55441                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014" / 0.018" GUIDE WIRE
TRIREME MEDICAL, INC.             510(k) NO: K103534

(TRADITIONAL)
ATTN: SHIVA  ARDAKANI             PHONE NO : 925 931 1300   
7060 Koll Center Parkway Suite 300SE DECISION MADE: 05-JAN-11
Pleasanton CA 94566               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: BIOMED WOUND CLEANSER
BIOMED LABORATORIES, INC          510(k) NO: K100613(TRADITIONAL)
ATTN: DONALD G WHITE              PHONE NO : 972 989 7646   
2713 INDUSTRIAL LANE              SE DECISION MADE: 05-JAN-11
GARLAND TX 75041                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CALIBER SPACER
GLOBUS MEDICAL INC.               510(k) NO: K102293

(TRADITIONAL)
ATTN: KELLY J BAKER               PHONE NO : 610 930 1800   
2460 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 05-JAN-11
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LTF-Y0009; MAJ-YOO41; XOEV-3D1
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K102379

(TRADITIONAL)
ATTN: STACY A KLUESNER, M.S. RAC  PHONE NO : 484 896 5405   
3500 CORPORATE PARKWAY PO BOX 610 SE DECISION MADE: 05-JAN-11
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINEANALYER MODEL SAPOC
OPTASIA MEDICAL                   510(k) NO: K103475

(TRADITIONAL)
ATTN: ANTHONY  HOLMES             PHONE NO : 011 441 614917860
HAW BANK HOUSE, HIGH STREET       SE DECISION MADE: 05-JAN-11
CHEADLE, CHESHIRE    UK SK8 1AL   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S9 VPAP ST WITH H5I
RESMED LTD.                       510(k) NO: K102513

(TRADITIONAL)
ATTN: DAVID  D'CRUZ               PHONE NO : 858 836 5984   
9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 05-JAN-11
KEARNEY MESA CA 92123             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CENTRAL MONITORING SYSTEM
EDAN INSTRUMENTS, INC.            510(k) NO: K100358

(TRADITIONAL)
ATTN: WILLIAM  STERN              PHONE NO : 914 376 5200   
1 ODELL PLAZA                     SE DECISION MADE: 06-JAN-11
YONKERS NY 10701                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
ACCLARENT, INC.                   510(k) NO: K100577

(TRADITIONAL)
ATTN: KERI  YEN                   PHONE NO : 650 687 5874   
1525-B O'BRIEN DR.                SE DECISION MADE: 06-JAN-11
MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KENZ CARDY302 MAX
SUZUKEN CO., LTD.                 510(k) NO: K101024

(TRADITIONAL)
ATTN: LINDA  MORGAN               PHONE NO : 972 480 9554   
1201 RICHARDSON SUITE 280         SE DECISION MADE: 06-JAN-11
RICHARDSON TX 75080               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE GRAPPLR AND GRAPPLR EXTENDER
TAG MEDICAL CORP.                 510(k) NO: K101616

(TRADITIONAL)
ATTN: GEORGE J HATTUB             PHONE NO : 508 479 6116   
291 HILLSIDE AVENUE               SE DECISION MADE: 06-JAN-11
SOMERSET MA 02726                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARVIEW EXACT II INFLUENZA A & B TEST
ALERE SCARBOROUGH, INC D/B/A BINAX510(k) NO: K103610

(SPECIAL)
ATTN: ANNE  JEPSON                PHONE NO : 207 730 5750   
10 SOUTHGATE ROAD                 SE DECISION MADE: 06-JAN-11
SCARBOROUGH ME 04074              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD NEXIVA CLOSED IV CATHETER SYSTEM
BECTON DICKINSON INFUSION THERAPY 510(k) NO: K102520

(SPECIAL)
ATTN: JUSTICE  ALDER              PHONE NO : 801 565 2662   
9450 SOUTH STATE ST.              SE DECISION MADE: 06-JAN-11
SANDY UT 84070                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEOPOP INFANT RESUSCITATOR WITH FLOW METER
NEOFORCE GROUP, INC.              510(k) NO: K102649

(TRADITIONAL)
ATTN: MONICA  FERRANTE            PHONE NO : 215 672 6800   
35 COMMERCE DR.                   SE DECISION MADE: 06-JAN-11
IVYLAND PA 18974                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)
SORIN GROUP DEUTSCHLAND GMBH      510(k) NO: K103168

(TRADITIONAL)
ATTN: ROSINA  ROBINSON            PHONE NO : 508 643 0434   
49 PLAIN STREET                   SE DECISION MADE: 06-JAN-11
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUPRO MODEL 13016901
CAO GROUP, INC.                   510(k) NO: K103160

(TRADITIONAL)
ATTN: ROBERT K LARSEN             PHONE NO : 801 256 9282   
4628 WEST SKYHAWK DRIVE           SE DECISION MADE: 06-JAN-11
WEST JORDAN UT 84084              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE ADDITION
OB THE-ADDITION, LLC              510(k) NO: K102683

(TRADITIONAL)
ATTN: REBECCA K PINE              PHONE NO : 760 809 5178   
2206 MODOC ROAD #3                SE DECISION MADE: 06-JAN-11
SANTA BARBARA CA 93101            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561
OPTI MEDICAL SYSTEMS INC.         510(k) NO: K093280

(TRADITIONAL)
ATTN: LEN  OWENS                  PHONE NO : 770 510 4444   
235 HEMBREE PARK DRIVE            SE DECISION MADE: 07-JAN-11
ROSWELL GA 30076                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
APOLLO SPINE, INC.                510(k) NO: K101588

(TRADITIONAL)
ATTN: CHRISTINE  SANTAGATE        PHONE NO : 781 828 4400   
75 MILL STREET                    SE DECISION MADE: 07-JAN-11
STOUGHTON MA 02072                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ON CALL PLUS DIABETES MONITORING SOFTWARE
ACON LABORATORIES, INC.           510(k) NO: K101371

(TRADITIONAL)
ATTN: RICHARD  LENART             PHONE NO : 858 875 8019   
10125 MESA RIM RD.                SE DECISION MADE: 07-JAN-11
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX SWIVELOCK ANCHORS
ARTHREX, INC.                     510(k) NO: K101823

(TRADITIONAL)
ATTN: SALLY  FOUST                PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 07-JAN-11
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS DHEA-S CALCHECK 5
ROCHE DIAGNOSTICS                 510(k) NO: K103402

(TRADITIONAL)
ATTN: KELLY C O'MAINE ADAMS       PHONE NO : 317 521 3577   
9115 HAGUE ROAD                   SE DECISION MADE: 07-JAN-11
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTELLIVUE MX40 PATIENT MONITOR
PHILLIPS MEDICAL SYSTEMS          510(k) NO: K103646

(SPECIAL)
ATTN: CLAIRE  ARAKAKI             PHONE NO : 978 659 4348   
3000 MINUTEMAN RD.                SE DECISION MADE: 07-JAN-11
ANDOVER MA 01810 1099             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLORADO CATHETER STERILESURE - NEW NAME "PERFIC CATH"
ADAPTA MEDICAL, INC               510(k) NO: K103043

(TRADITIONAL)
ATTN: NEIL  BURRIS                PHONE NO : 720 323 1662   
4250 GROVE STREET                 SE DECISION MADE: 07-JAN-11
DENVER CO 80211                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 6250 ULTRASOUND SYTEMS
ESAOTE, S.P.A.                    510(k) NO: K103152

(TRADITIONAL)
ATTN: ALLISON  SCOTT              PHONE NO : 317 569 9500   
11460 N MERIDIAN ST., STE 150     SE DECISION MADE: 07-JAN-11
CARMEL IN 46032                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104
REPROCESSING PRODUCTS CORP.       510(k) NO: K101750

(TRADITIONAL)
ATTN: WALLY  JANSEN               PHONE NO : 763 420 4355   
8662 COMSTOCK LN. NORTH           SE DECISION MADE: 07-JAN-11
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)
OMNI SURGICAL, L.P.               510(k) NO: K102322

(TRADITIONAL)
ATTN: J. D WEBB                   PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 07-JAN-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BACKSTOP CATHETER
PLUROMED, INC.                    510(k) NO: K103349

(ABBREVIATED)
ATTN: JAMES  WILKIE               PHONE NO : 781 932 0574   
25-H OLYMPIA AVENUE               SE DECISION MADE: 07-JAN-11
WOBURN MA 01801                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE BLOOD PRESSURE CUFF
WUXI MEDICAL INSTRUMENT FACTORY   510(k) NO: K102823

(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 64264467
P.O. BOX 237-023                  SE DECISION MADE: 07-JAN-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
HOLOGIC, INC.                     510(k) NO: K103512

(SPECIAL)
ATTN: GAIL  YAEKER-DAUNI          PHONE NO : 203 731 8337   
36 APPLE RIDGE ROAD               SE DECISION MADE: 07-JAN-11
DANBURY CT 06810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING
HOSPIRA, INC.                     510(k) NO: K103224

(SPECIAL)
ATTN: KAREN  KEENER               PHONE NO : 224 212 5316   
375 NORTH FIELD DR. BLDG. 2       SE DECISION MADE: 07-JAN-11
LAKE FOREST IL 60045 5045         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVOLUTION MP TOTAL KNEE SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K102380

(SPECIAL)
ATTN: RYAN  ROSS                  PHONE NO : 901 867 4401   
5677 AIRLINE RD.                  SE DECISION MADE: 07-JAN-11
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BREEZE C MODEL C (3W), BREEZE C (4W)
AFIKIM ELECTRIC VEHICLES          510(k) NO: K102304

(TRADITIONAL)
ATTN: AVNER  FISHBEIN             PHONE NO : 972 467 54814
KIBBUTZ AFIKIM                    SE DECISION MADE: 07-JAN-11
KIBBUTZ AFIKIM    IS 15148        510(k) STATEMENT

DEVICE: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
CONFORMIS, INC.                   510(k) NO: K103117

(SPECIAL)
ATTN: AMITA S SHAH                PHONE NO : 781 345 9164   
2 FOURTH AVENUE                   SE DECISION MADE: 07-JAN-11
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDPOR CONTAIN CAN IMPLANT
POREX SURGICAL, INC.              510(k) NO: K102184

(TRADITIONAL)
ATTN: STEPHANIE  FULLARD          PHONE NO : 678 479 1758   
15 DART RD.                       SE DECISION MADE: 07-JAN-11
NEWNAN GA 30265                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K102298

(TRADITIONAL)
ATTN: KRISTINE  CHRISTO           PHONE NO : 508 828 3359   
325 PARAMOUNT DR.                 SE DECISION MADE: 07-JAN-11
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMDIA-1000
SOUTHMEDIC, INC.                  510(k) NO: K101953

(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 07-JAN-11
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPLANT-ONE SYSTEM
CUSTOM DENTAL IMPLANTS INC        510(k) NO: K102822

(TRADITIONAL)
ATTN: KAREN E WARDEN              PHONE NO : 440 729 8457   
8202 SHERMAN ROAD                 SE DECISION MADE: 10-JAN-11
CHESTERLAND OH 44026              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02
YU LONG SHENG TECHNOLOGY CO., LTD 510(k) NO: K102508

(TRADITIONAL)
ATTN: TONY C CHANG                PHONE NO : 886 422 972787
NO. 15, ALLEY 71, CHENPING 1ST BEISE DECISION MADE: 10-JAN-11
TAICHUNG    TW 406                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
NANOSPHERE, INC.                  510(k) NO: K103209

(TRADITIONAL)
ATTN: GREGORY W SHIPP             PHONE NO : 847 400 9000   
4088 Commercial Avenue            SE DECISION MADE: 10-JAN-11
Northbrook IL 60062               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALLOFUSE PLUS
ALLOSOURCE, INC.                  510(k) NO: K103036

(TRADITIONAL)
ATTN: PAMELA  VETTER              PHONE NO : 720 873 0213   
6278 S. TROY CIRCLE               SE DECISION MADE: 10-JAN-11
CENTENNIAL CO 80111               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOSMAN USB BLOOD PRESSURE MONITOR; WRIST TYPE AND UPPER ARM TYPE
HOSMAN INTERNATIONAL CO., LTD     510(k) NO: K103046

(TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 886 352 08829
NO 58, FU CHIUN STREET            SE DECISION MADE: 10-JAN-11
HSIN CHU CITY    TW 30067         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAMLOG VARIO SR ABUTMENTS
ALTATEC GMBH                      510(k) NO: K103252

(TRADITIONAL)
ATTN: LINDA  SCHULZ               PHONE NO : 858 792 1235   
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 10-JAN-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVAMAX VERTEBRAL BALLOON
CAREFUSION                        510(k) NO: K103064

(TRADITIONAL)
ATTN: JOY  GREIDANUS              PHONE NO : 918 865 4727   
1500 WAUKEGAN ROAD                SE DECISION MADE: 10-JAN-11
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDIT MICROCV CARDIAC MARKERS LINEARITY SET
AALTO SCIENTIFIC LTD.             510(k) NO: K102617

(TRADITIONAL)
ATTN: DESSI  LYAKOV               PHONE NO : 760 431 7922   
1959 KELLOGG AVE.                 SE DECISION MADE: 10-JAN-11
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX
ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K103033

(TRADITIONAL)
ATTN: KATHLEEN M RUTHERFORD       PHONE NO : 973 576 0139   
10 POMEROY RD.                    SE DECISION MADE: 10-JAN-11
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER
ABBOTT VASCULAR-CARDIAC THERAPIES 510(k) NO: K103110

(TRADITIONAL)
ATTN: SUZANNE  REDMAN             PHONE NO : 951 914 3243   
26531 YNEZ RD. MAILING P.O. BOX 90SE DECISION MADE: 10-JAN-11
TEMECULA CA 92589 9018            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMBRYOSCOPE AND EMBRYOSLIDE
UNISENSE FERTILITECH A/S          510(k) NO: K092183

(TRADITIONAL)
ATTN: METTE  MUNCH                PHONE NO : 45 894 49500
BRENDSTRUPGARDSVEJ 21F            SE DECISION MADE: 11-JAN-11
ARRHUS    DA DK-8200              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HVR PAIN RELIEF DEVICE
H.V.R., INC.                      510(k) NO: K101716

(TRADITIONAL)
ATTN: JESSANY  GARRETT            PHONE NO : 808 217 2556   
7821 ORION AVE SUITE 200          SE DECISION MADE: 11-JAN-11
VAN NUYS CA 91406                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K103275

(TRADITIONAL)
ATTN: ALICIA  BUSTOS-JUERGENSEN   PHONE NO : 610 448 4056   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 11-JAN-11
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS
OLYMPUS WINTER & IBE GMBH         510(k) NO: K102781

(SPECIAL)
ATTN: STACY  ABBATIELLO           PHONE NO : 484 896 5405   
3500 CORPORATE PKWAY PO BOX 610   SE DECISION MADE: 11-JAN-11
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP
B.J.ZH.F. PANTHER MEDICAL EQUIPMEN510(k) NO: K103470

(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 86 10 82387441
ROOM 1606 BLDG. 1 JIANXIANG YU NO.SE DECISION MADE: 11-JAN-11
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BT-CATH
UTAH MEDICAL PRODUCTS, INC.       510(k) NO: K101535

(TRADITIONAL)
ATTN: KEVIN  CORNWELL             PHONE NO : 801 566 1200   
7043 SOUTH 300 WEST               SE DECISION MADE: 11-JAN-11
MIDVALE UT 84047 1048             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIO MED MODEL A102, H104, O101, P103, AND Z100
CARDIO MEDICAL PRODUCTS, INC.     510(k) NO: K103159

(TRADITIONAL)
ATTN: NICK  MENDISE               PHONE NO : 973 586 9500   
385 FRANKLIN AVE. STE. L          SE DECISION MADE: 11-JAN-11
ROCKAWAY NJ 07866                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD
ORIDION CAPNOGRAPHY, INC.         510(k) NO: K101995

(TRADITIONAL)
ATTN: RACHEL  WEISSBROD           PHONE NO : 
160 GOULD STREET                  SE DECISION MADE: 11-JAN-11
NEEDHAM HEIGHTS MA 02494          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR
APOLLO SPINE, INC.                510(k) NO: K102121

(TRADITIONAL)
ATTN: CHRISTINE  SANTAGATE        PHONE NO : 781 828 4400   
75 MILL STREET                    SE DECISION MADE: 12-JAN-11
STOUGHTON MA 02072                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K103645(SPECIAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DR                  SE DECISION MADE: 12-JAN-11
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIXED MEDIA MARKER
CORTEX MANUFACTURING, INC.        510(k) NO: K102506

(TRADITIONAL)
ATTN: ANDREW  JONES               PHONE NO : 425 334 2277   
421 S. DAVIES RD.                 SE DECISION MADE: 12-JAN-11
LAKE STEVENS WA 98258             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTXIDE 50 HS/MS
EL.EN. ELECTRONIC ENGINEERING SPA 510(k) NO: K101904

(TRADITIONAL)
ATTN: PAOLO  PERUZZI              PHONE NO : 39 055 8826807
17 VIA BALDANZESE                 SE DECISION MADE: 12-JAN-11
CALENZANO    IT 50041             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A
GE HEALTHCARE COILS (USA INSTRUMEN510(k) NO: K103365

(TRADITIONAL)
ATTN: MICHAEL S PRETO             PHONE NO : 330 995 8333   
1515 DANNER DR                    SE DECISION MADE: 12-JAN-11
AURORA OH 44202 9273              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER
SHANTOU I NSTITUTE OF ULTRASONIC I510(k) NO: K103144

(TRADITIONAL)
ATTN: BOB  LEIKER                 PHONE NO : 925 556 1302   
7263 CRONIN CIRCLE                SE DECISION MADE: 12-JAN-11
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +
G SURGICAL CO., LTD.              510(k) NO: K103070

(TRADITIONAL)
ATTN: DONALD  GRAFTON             PHONE NO : 66 0 27306288
152 SOI RAMKHAMHAENG 138 SAPANSUNGSE DECISION MADE: 12-JAN-11
BANGKOK    TH 10240               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)
KINAMED INCORPORATED              510(k) NO: K102834

(SPECIAL)
ATTN: ANTHONY  ROSE               PHONE NO : 805 384 2748   
820 FLYNN ROAD                    SE DECISION MADE: 12-JAN-11
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)
VARIAN MEDICAL SYSTEMS, ONCOLOGY S510(k) NO: K103394

(TRADITIONAL)
ATTN: VY  TRAN                    PHONE NO : 650 424 5731   
911 HANSEN WAY                    SE DECISION MADE: 12-JAN-11
PALO ALTO CA 94304                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXPECT ENDOSCOPIC ASPIRATION NEEDLE
BOSTON SCIENTIFIC CORP.           510(k) NO: K110030

(SPECIAL)
ATTN: ASHLEY  PYLE                PHONE NO : 508 683 4359   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 12-JAN-11
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ISCREEN VISION SCREENER
ISCREEN VISION, INC.              510(k) NO: K102651

(SPECIAL)
ATTN: BUCK  BROWN                 PHONE NO : 901 201 6132   
110 TIMBERCREEK DRIVE SUITE# 2    SE DECISION MADE: 12-JAN-11
CORDOVA TN 38018                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BREATHSCN PRO
AKERS BIOSCIENCES, INC.           510(k) NO: K102338

(TRADITIONAL)
ATTN: BARBARA A BAGBY             PHONE NO : 856 848 8698   
201 GROVE RD.                     SE DECISION MADE: 12-JAN-11
THOROFARE NJ 08086                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSBONE DENTAL
CURASAN AG                        510(k) NO: K102872

(TRADITIONAL)
ATTN: CYNTHIA J NOLTE             PHONE NO : 508 643 0434   
49 PLAIN STREET                   SE DECISION MADE: 12-JAN-11
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM
VIEWRAY INCORPORATED              510(k) NO: K102915

(TRADITIONAL)
ATTN: JANICE  BROWNLEE            PHONE NO : 440 703 3210   
2 THERMOFISHER WAY                SE DECISION MADE: 12-JAN-11
OAKWOOD OH 44146                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DANA CLASS 6 EMULATING INDICATOR
DANA PRODUCTS, INC.               510(k) NO: K100891

(TRADITIONAL)
ATTN: HARRY  BALA                 PHONE NO : 847 455 2881   
7 COREY DR.                       SE DECISION MADE: 13-JAN-11
SOUTH BARINGTON IL 60010          510(k) STATEMENT

DEVICE: PLATELIA ASPERGILLUS EIA MODEL 62793
BIO-RAD                           510(k) NO: K093678

(TRADITIONAL)
ATTN: CHRISTOPHER  BENTSEN        PHONE NO : 425 881 8300   
6565 185TH AVENUE NE              SE DECISION MADE: 13-JAN-11
REDMOND WA 98052                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809
DM SYSTEMS, INCORPORATED          510(k) NO: K101614

(TRADITIONAL)
ATTN: MICHAEL  ZMUDA              PHONE NO : 916 439 2564   
1105 BUCHBRUSH DR                 SE DECISION MADE: 13-JAN-11
FOLSM CA 95630                    510(k) STATEMENT

DEVICE: FLEBOSET DOUBLE
LABORATORIOS GRIFOLS, S.A.        510(k) NO: K102590

(ABBREVIATED)
ATTN: SEBASTIAN  GASCON           PHONE NO : 349 357 10100
POL. LEVANTE C/CAN GUASCH, 2      SE DECISION MADE: 13-JAN-11
PARETS DEL VALLES, BARCELONA    SP510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FETAL MONITORS, MODELS F2 AND F3
EDAN INSTRUMENTS, INC.            510(k) NO: K102140

(TRADITIONAL)
ATTN: WILLIAM  STERN              PHONE NO : 
NANHAI ROAD 1019#, SHEKOU, NANSHENSE DECISION MADE: 13-JAN-11
SHENZHEN, GUANGDONG    CH         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CASPIAN SPINAL SYSTEM
K2M, INC.                         510(k) NO: K103232

(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR.,SE                 SE DECISION MADE: 13-JAN-11
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8
PHILIPS MEDICAL SYSTESMS          510(k) NO: K103652

(SPECIAL)
ATTN: LAWRENCE  MILANA            PHONE NO : 978 659 7860   
300 MINUTEMAN ROAD                SE DECISION MADE: 13-JAN-11
ANDOVER MA 01810 1099             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BONASIL A+ IMPRESSION MATERIALS
DMP LTD                           510(k) NO: K102836

(TRADITIONAL)
ATTN: DIMITRIS  PRANTSIDIS        PHONE NO : 003 022 99023041
2ND KM KALYVION AVENUE MARKOPOULO SE DECISION MADE: 13-JAN-11
MARKOPOULO    GR 19003            510(k) STATEMENT

DEVICE: SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)
A PLUS INTERNATIONAL, INC.        510(k) NO: K102861

(TRADITIONAL)
ATTN: SOLOMON  CHEN               PHONE NO : 909 591 5168   
5138 EUCALYPTUS AVE.,             SE DECISION MADE: 13-JAN-11
CHINO CA 91710                    510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR
MEDIVATORS REPROCESSING SYSTEMS   510(k) NO: K102996

(TRADITIONAL)
ATTN: LYNN  LUEDERS               PHONE NO : 763 553 2475   
14605 28TH AVE., NORTH            SE DECISION MADE: 13-JAN-11
MINNEAPOLIS MN 55447 4822         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH
SUMMIT MEDICAL PRODUCTS, INC      510(k) NO: K102460

(ABBREVIATED)
ATTN: MARKO  VAN AMEN             PHONE NO : 801 352 1888   
2480 SOUTH MAIN STREET            SE DECISION MADE: 13-JAN-11
SALT LAKE CITY UT 84115           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
HEBEI FAVOR PLASTIC CO., LTD      510(k) NO: K102613

(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
ROOM 1606 BLDG. 1 JIANXIANG YUAN NSE DECISION MADE: 13-JAN-11
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520
MEDICA CORP.                      510(k) NO: K100829

(TRADITIONAL)
ATTN: PHOTIOS  MAKRIS             PHONE NO : 781 275 7892   
5 OAK PARK DRIVE                  SE DECISION MADE: 14-JAN-11
BEDFORD MA 01730                  510(k) STATEMENT

DEVICE: E1 AVANTAGE HEAD
BIOMET MANUFACTURING CORP.        510(k) NO: K101336

(TRADITIONAL)
ATTN: BECKY  EARL                 PHONE NO : 800 348 9500   
56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 14-JAN-11
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3
GENX INTL., INC.                  510(k) NO: K092963

(TRADITIONAL)
ATTN: MICHAEL D CECCHI            PHONE NO : 203 453 1700   
393 SOUNDVIEW RD.                 SE DECISION MADE: 14-JAN-11
GUILFORD CT 06437                 510(k) STATEMENT

DEVICE: SOUNDBITE HEARING SYSTEM BY SONITUS
SONITUS MEDICAL  INC              510(k) NO: K100649

(TRADITIONAL)
ATTN: ROBERT J CHIN               PHONE NO : 650 593 5225   
25 HARTFORD AVE                   SE DECISION MADE: 14-JAN-11
SAN CARLOS CA 94070               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDIT MICROCV PROTEIN LINEARITY SET
AALTO SCIENTIFIC LTD.             510(k) NO: K101216

(TRADITIONAL)
ATTN: DESSI  LYAKOV               PHONE NO : 760 431 7922   
1959 KELLOGG AVE.                 SE DECISION MADE: 14-JAN-11
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ
OLYMPUS WINTER & IBE GMBH         510(k) NO: K103032

(TRADITIONAL)
ATTN: STACY  ABBATIELLO KLUESNER  PHONE NO : 484 896 5405   
3500 CORPORATE PARKWAY            SE DECISION MADE: 14-JAN-11
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX
STRYKER CORP.                     510(k) NO: K102885

(SPECIAL)
ATTN: ZAMIR  BAR-DAVID            PHONE NO : 201 831 5718   
325 CORPORATE DRIVE               SE DECISION MADE: 14-JAN-11
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER
CODMAN & SHURTLEFF, INC.          510(k) NO: K102589

(SPECIAL)
ATTN: SHARON  MCDERMOTT           PHONE NO : 508 880 8349   
325 PARAMOUNT DR.                 SE DECISION MADE: 14-JAN-11
RAYNHAM MA 02767 0350             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,
DIAZYME LABORATORIES              510(k) NO: K102432

(TRADITIONAL)
ATTN: ABHIJIT  DATTA              PHONE NO : 858 455 4762   
12889 GREGG COURT                 SE DECISION MADE: 14-JAN-11
POWAY CA 92064                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER
NAVILYST MEDICAL, INC.            510(k) NO: K103353

(SPECIAL)
ATTN: WANDA  CARPINELLA           PHONE NO : 508 658 7929   
26 FOREST STREET                  SE DECISION MADE: 14-JAN-11
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NORFOLK MEDICAL NORPORT FAMILY OF PORTS
NORFOLK MEDICAL PRODUCTS, INC.    510(k) NO: K102385

(TRADITIONAL)
ATTN: MICHAEL J DALTON            PHONE NO : 847 674 7075   
7350 NORTH RIDGEWAY               SE DECISION MADE: 14-JAN-11
SKOKIE IL 60076                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
GENORAY CO., LTD.                 510(k) NO: K103182

(TRADITIONAL)
ATTN: JAE  KIM                    PHONE NO : 714 289 8020   
1073 N, BATAVIA ST                SE DECISION MADE: 14-JAN-11
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFRARED EAR THERMOMETER, MODEL IR-04MT
VEGA TECHNOLOGIES, INC.           510(k) NO: K102934

(TRADITIONAL)
ATTN: JOSEPH  LU                  PHONE NO : 886 2 25416996
11F-13, 100 CHANG-CHUN RD.        SE DECISION MADE: 14-JAN-11
TAIPEI    TW 104                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
CMA MICRODIALYSIS AB              510(k) NO: K102077

(TRADITIONAL)
ATTN: NANCY  BLANCO               PHONE NO : 978 251 1940   
73 PRINCETON STREET               SE DECISION MADE: 14-JAN-11
NORTH CHELMSFORD MA 01863         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AHWON'S IPL SYSTEM
AHWON MEDI INSTRUMENT CO., LTD    510(k) NO: K102857

(TRADITIONAL)
ATTN: YOUNG  CHI                  PHONE NO : 973 278 5222   
111 ELLISON STREET                SE DECISION MADE: 14-JAN-11
PATERSON NJ 07505                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOFLEX ROD
ORTHO-PRO LLC                     510(k) NO: K102601

(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 14-JAN-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMC HYPODERMIC NEEDLE
INTERNATIONAL MEDSURG CONNECTION  510(k) NO: K102584

(TRADITIONAL)
ATTN: PETER  KIM                  PHONE NO : 847 619 9926   
935 N PLUM GROVE RD., STE F       SE DECISION MADE: 14-JAN-11
SCHAUMBURG IL 60173               510(k) STATEMENT

DEVICE: 84E SERIES SINGLE PLY WRAPPER
LAC MAC, LTD.                     510(k) NO: K102864

(TRADITIONAL)
ATTN: JEFFREY O STULL             PHONE NO : 512 288 8272   
7809 ADELAIDE DR.                 SE DECISION MADE: 14-JAN-11
AUSTIN TX 78739                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: G-PROX EZ ENDOSCOPIC GRASPER
USGI MEDICAL                      510(k) NO: K103688

(SPECIAL)
ATTN: MARY  LOU MOONEY            PHONE NO : 949 369 3890   
1140 CALLE CORDILLERA             SE DECISION MADE: 14-JAN-11
SAN CLEMENTE CA 92673             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KING COBRA ANTERIOR CERVICAL PLATE
EMINENT SPINE                     510(k) NO: K103068

(TRADITIONAL)
ATTN: KAREN E WARDEN              PHONE NO : 440 729 8457   
8202 SHERMAN ROAD                 SE DECISION MADE: 14-JAN-11
CHESTERLAND OH 44026 2141         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WRIST FULLY AUTOMATIC BLOOD PRESSURE METER
FUDAKANG INDUSTRIES CO., LTD      510(k) NO: K110013

(TRADITIONAL)
ATTN: STEPHEN  LING               PHONE NO : 867 558 3089699
ROOM 2706 , BLOCK A ZHONGFANG JIN SE DECISION MADE: 14-JAN-11
SHENZHEN, GUANGDON    CH 518034   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES
ALMA LASERS, INC.                 510(k) NO: K103501(SPECIAL)
ATTN: TATIANA  EPSTEIN            PHONE NO : 224 377 2011   
485 HALF DAY RD. SUITE #100       SE DECISION MADE: 14-JAN-11
BUFFALO GROVE IL 60089            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
GIVEN IMAGING LTD.                510(k) NO: K103088

(TRADITIONAL)
ATTN: TIM  THOMAS                 PHONE NO : 972 4 9097936
HERMON BUILDING NEW INDUSTRIAL PARSE DECISION MADE: 14-JAN-11
YOQNEAM    IS 20692               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROLYTE ELECTROLYTE ANALYZER
DIAMOND DIAGNOSTICS, INC.         510(k) NO: K102959

(TRADITIONAL)
ATTN: LIANN  VOO                  PHONE NO : 508 429 0450   
333 FISKE ST.                     SE DECISION MADE: 14-JAN-11
HOLLISTON MA 01746                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALIF SPINAL TRUSS INTERBODY FUSION DEVICE
4-WEB SPINE, LLC                  510(k) NO: K083894

(TRADITIONAL)
ATTN: RICHARD  JANSEN             PHONE NO : 952 431 5999   
13540 GUILD AVENUE                SE DECISION MADE: 18-JAN-11
APPLE VALLEY MN 55124             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650
SHANGHAI APOLO MEDICAL TECHNOLOGIE510(k) NO: K093627

(TRADITIONAL)
ATTN: BRANDON  CHOI               PHONE NO : 714 523 1592   
49 CANDLEWOOD WAY                 SE DECISION MADE: 18-JAN-11
BUENA PARK CA 90621               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RVT CTO DEVICE
REVASCULAR THERAPEUTICS, INC.     510(k) NO: K101599

(TRADITIONAL)
ATTN: NANCY  LINCE                PHONE NO : 408 617 0770   
766 PALOMAR AVENUE                SE DECISION MADE: 18-JAN-11
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXGEN PERIPHERAL GUIDE CATHETER
NEXGEN MEDICAL SYSTEMS, INC.      510(k) NO: K102979

(TRADITIONAL)
ATTN: CRAIG  PAGAN                PHONE NO : 321 728 0126   
1050 W. NASA BLVD. SUITE 136      SE DECISION MADE: 18-JAN-11
MELBOURNE FL 32901                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIO MED
CARDIO MEDICAL PRODUCTS, INC.     510(k) NO: K103334

(TRADITIONAL)
ATTN: NICK  MENDISE               PHONE NO : 973 586 9500   
385 FRANKLIN AVE. STE. L          SE DECISION MADE: 18-JAN-11
ROCKAWAY NJ 07866                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VEPER SYSTEM, EXPEDIUM SYSTEM
DEPUY SPINE, INC.                 510(k) NO: K103133

(SPECIAL)
ATTN: EUGENE  BANG                PHONE NO : 508 977 3966   
325 PARAMOUNT DR.                 SE DECISION MADE: 18-JAN-11
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05
SORIN GROUP DEUTSCHLAND GMBH      510(k) NO: K103469

(TRADITIONAL)
ATTN: ROSINA  ROBINSON            PHONE NO : 508 643 0434   
49 PLAIN STREET                   SE DECISION MADE: 18-JAN-11
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WBR XPRESS PET
ULTRASPECT LTD.                   510(k) NO: K103710

(SPECIAL)
ATTN: DAN  LAOR                   PHONE NO : 972 482 46632
6 SIRENI                          SE DECISION MADE: 19-JAN-11
HAIFA    IS 32972                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SP-FIX SPINOUS PROCESS FIXATION PLATE
GLOBUS MEDICAL, INC.              510(k) NO: K102195

(TRADITIONAL)
ATTN: KELLY J BAKER               PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE. VALLEYSE DECISION MADE: 19-JAN-11
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: R3 XLPE ANTEVERTED LINERS
SMITH & NEPHEW, INC.              510(k) NO: K102370

(ABBREVIATED)
ATTN: MEGAN  BEVILL               PHONE NO : 901 399 5340   
1450 EAST BROOKS RD.              SE DECISION MADE: 19-JAN-11
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IO-FLEX CATHETER
BAXANO, INC.                      510(k) NO: K102594

(TRADITIONAL)
ATTN: EDWARD J SINCLAIR           PHONE NO : 408 514 2220   
655 RIVER OAKS PKWY               SE DECISION MADE: 19-JAN-11
SAN JOSE CA 95134                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CPS DIRECT SL II SLITTABLE OUTER CATHETER
ST. JUDE MEDICAL, CARDIAC RHYTHM M510(k) NO: K103250

(SPECIAL)
ATTN: COLLEEN  CANAN              PHONE NO : 818 493 2960   
15900 VALLEY VIEW CT.             SE DECISION MADE: 19-JAN-11
SYLMAR CA 91342                   510(k) STATEMENT

DEVICE: ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM
ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K103533

(SPECIAL)
ATTN: JULIE  GLENDRANGE           PHONE NO : 310 533 9966   
386 BEECH AVENUE UNIT B6          SE DECISION MADE: 19-JAN-11
TORRANCE CA 90501                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALBOGRAFT VASCULAR PROSTHESIS
LEMAITRE VASCULAR, INC.           510(k) NO: K103080

(TRADITIONAL)
ATTN: ANDREW  HODGKINSON          PHONE NO : 781 221 2266   
63 2ND AVENUE                     SE DECISION MADE: 19-JAN-11
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERILE SALINE SOLUTION
CACHET PHARMACEUTICALS PVT. LTD.  510(k) NO: K102165

(TRADITIONAL)
ATTN: SHIVKUMAR  AGRAWAL          PHONE NO : 919 967 655855
415 SHAH NAHAR, WORLI             SE DECISION MADE: 19-JAN-11
MUMBAI    IN 400 018              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS
LUTRONIC CORPORATION              510(k) NO: K100610

(TRADITIONAL)
ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207 1245   
5 TIMBER LANE                     SE DECISION MADE: 20-JAN-11
NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900
GAYMAR INDUSTRIES, INC.           510(k) NO: K100585

(TRADITIONAL)
ATTN: BRIAN L ORWAT               PHONE NO : 716 662 2551   
10 CENTRE DR.                     SE DECISION MADE: 20-JAN-11
ORCHARD PARK NY 14127             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TQ HBA1C GEN3
ROCHE                             510(k) NO: K102914

(SPECIAL)
ATTN: KATHIE J GOODWIN            PHONE NO : 317 521 3831   
9115 HAGUE RD                     SE DECISION MADE: 20-JAN-11
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMERALD SPINAL SYSTEM
MAZOR SURGICAL TECHNOLOGIES LTD.  510(k) NO: K101446(TRADITIONAL)
ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5804   
1331 H STREET NW, 12TH FLOOR      SE DECISION MADE: 20-JAN-11
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE
SORIN GROUP DEUTSCHLAND GMBH      510(k) NO: K103762

(SPECIAL)
ATTN: ROSINA  ROBINSON, RN, MED, RPHONE NO : 508 643 0434   
49 PLAIN STREET                   SE DECISION MADE: 20-JAN-11
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DMC COMPOSITE 2
KERR CORPORATION                  510(k) NO: K103351

(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602   
1717 WEST COLLINS AVENUE          SE DECISION MADE: 20-JAN-11
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TERASON T3200 ULTRASOUND SYSTEM
TERATECH CORP.                    510(k) NO: K110020

(TRADITIONAL)
ATTN: CHARLES F HOTTINGER         PHONE NO : 206 780 7945   
77-79 TERRACE HALL AVE.           SE DECISION MADE: 20-JAN-11
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE
MIRADOR BIOMEDICAL, INC.          510(k) NO: K103715(SPECIAL)
ATTN: JUSTIN  HULVERSHORN         PHONE NO : 206 295 3372   
2815 WASTLAKE AVENUE SUITE 300    SE DECISION MADE: 20-JAN-11
SEATTLE WA 98102                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOBIUS ULTRASOUND IMAGING SYSTEM
MOBISANTE, INC.                   510(k) NO: K102153

(TRADITIONAL)
ATTN: SAILESH  CHUTANI            PHONE NO : 650 804 5421   
14035 NE 85TH COURT               SE DECISION MADE: 20-JAN-11
REDMOND WA 98052                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASCOPRESS SEQUENTIAL DVT PUMP
COMPRESSION THERAPY CONCEPTS      510(k) NO: K102940

(SPECIAL)
ATTN: LEONARD  NASS               PHONE NO : 732 544 0800   
35 JAMES WAY                      SE DECISION MADE: 20-JAN-11
EATONTOWN NJ 07724                510(k) STATEMENT

DEVICE: ELECYSYS SHBG
ROCHE DIAGNOSTICS                 510(k) NO: K102814

(TRADITIONAL)
ATTN: KELLY  FRENCH               PHONE NO : 317 521 2458   
9115 HAGUE ROAD PO BOX 50416      SE DECISION MADE: 20-JAN-11
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PCP/PC STETHOSCOPE
RNK PRODUCTS, INC.                510(k) NO: K102893

(TRADITIONAL)
ATTN: CHARLES R ABBRUSCATO        PHONE NO : 321 626 7717   
4195 US HWY 1 SUITE 101           SE DECISION MADE: 20-JAN-11
ROCKLEDGE FL 32955                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTA SYSTEM DUOLITE
QUANTA SYSTEM, S.P.A.             510(k) NO: K103539

(TRADITIONAL)
ATTN: ISABELLA  CARRER            PHONE NO : 390 331 37679
VIA IV NOVEMBRE,116               SE DECISION MADE: 20-JAN-11
SOLBIATE OLONA(VA)    IT 21058    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE
MEDERI THERAPEUTICS INC.          510(k) NO: K103017

(TRADITIONAL)
ATTN: CURT  RAYMOND               PHONE NO : 203 922 0105   
80 SHELTON TECHNOLOGY CENTER      SE DECISION MADE: 20-JAN-11
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS
CHEMTRON BIOTECH, INC.            510(k) NO: K102203

(TRADITIONAL)
ATTN: JANE  ZHANG                 PHONE NO : 858 530 2868   
8370 JUNIPER CREEK LANE SUITE 1-2 SE DECISION MADE: 20-JAN-11
SAN DIEGO CA 92126                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES
ORTHO SOLUTIONS LIMITED           510(k) NO: K102743

(TRADITIONAL)
ATTN: AL  LIPPINCOTT              PHONE NO : 952 492 5858   
3150 EAST 200TH STREET            SE DECISION MADE: 20-JAN-11
PRIOR LAKE MN 55372               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)
SORIN GROUP DEUTSCHLAND GMBH      510(k) NO: K103468

(TRADITIONAL)
ATTN: ROSINA  ROBINSON            PHONE NO : 508 643 0434   
49 PLAIN STREET                   SE DECISION MADE: 20-JAN-11
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSAVER
OCULAR SYSTEMS, INC.              510(k) NO: K090626(TRADITIONAL)
ATTN: KURT  WEBER                 PHONE NO : 336 784 4603   
101 N CHESTNUT STREET SUITE 301   SE DECISION MADE: 21-JAN-11
WINSTON-SALEM NC 27101            510(k) STATEMENT

DEVICE: LIPOCONTROL
OSYRIS MEDICAL                    510(k) NO: K090754

(TRADITIONAL)
ATTN: BLANDINE  BOUVET            PHONE NO : 33 3 20679044
60 AVENUE HALLEY F59650 VILLENEUVESE DECISION MADE: 21-JAN-11
FRANCE    FR F59650               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGO 4S
DIAMEDIX CORP.                    510(k) NO: K093101

(TRADITIONAL)
ATTN: GLENN  GERSTENFELD          PHONE NO : 305 324 2314   
2140 NORTH MIAMI AVE.             SE DECISION MADE: 21-JAN-11
MIAMI FL 33127                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM
ALMA LASERS, INC.                 510(k) NO: K101147

(TRADITIONAL)
ATTN: TATIANA  EPSTEIN            PHONE NO : 224 377 2011   
485 HALF DAY RD. SUITE #100       SE DECISION MADE: 21-JAN-11
BUFFALO GROVE IL 60089            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATION
PACIFIC CONSOLIDATED INDUSTRIES, L510(k) NO: K100957

(TRADITIONAL)
ATTN: GARY  CLARK                 PHONE NO : 951 479 0872   
12201 MAGNOLIA AVE.               SE DECISION MADE: 21-JAN-11
RIVERSIDE CA 92503                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FETCH 2 ASPIRATION CATHETER MODEL 109400-001
MEDRAD INTERVENTIONAL/POSSIS      510(k) NO: K101354

(TRADITIONAL)
ATTN: DOUG  ATKINS                PHONE NO : 763 780 4555   
9055 EVERGREEN BLVD NW            SE DECISION MADE: 21-JAN-11
MINNEAPOLIS MN 55433              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE
3M ESPE DENTAL PRODUCTS           510(k) NO: K110131

(TRADITIONAL)
ATTN: GINGER  CANTOR              PHONE NO : 651 733 1317   
3M CENTER, BUILDING 260-2A-11     SE DECISION MADE: 21-JAN-11
ST. PAUL MN 55144 1000            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
SYNTHES (USA)                     510(k) NO: K103243

(TRADITIONAL)
ATTN: CHRISTOPHER  HACK           PHONE NO : 610 719 6940   
1301 GOSHEN PKWY.                 SE DECISION MADE: 21-JAN-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFA WARMER I
ATOM MEDICAL CORPORATION          510(k) NO: K102227

(TRADITIONAL)
ATTN: TSUYOSHI  SUGINO            PHONE NO : 813 381 53632
3-18-15 HONGO                     SE DECISION MADE: 21-JAN-11
BUNKYO-KU, TOKYO    JA 113-0033   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOW ADHERENT AFM AG DRESSINGS
MILLIKEN HEALTHCARE PRODUCTS, LLC 510(k) NO: K103141

(SPECIAL)
ATTN: RONALD S WARREN, RAC        PHONE NO : 858 753 1961   
11440 W. BERNARDO COURT SUITE 300 SE DECISION MADE: 21-JAN-11
SAN DIEGO CA 92127                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REALEYE MODEL VCPS
NAVOTEK MEDICAL LTD               510(k) NO: K100625(TRADITIONAL)
ATTN: STEVEN B DATLOF, M.D., J.D. PHONE NO : 267 675 4613   
1835 MARKET ST. 29TH FLOOR        SE DECISION MADE: 21-JAN-11
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAPERLOC COMPLETE, SIZE 5 AND 6
BIOMET MANUFACTURING CORP.        510(k) NO: K103755(SPECIAL)
ATTN: BECKY  EARL                 PHONE NO : 574 267 6639   
PO BOX 587                        SE DECISION MADE: 21-JAN-11
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT
BIOREMEDI THERAPEUTIC SYSTEMS, INC510(k) NO: K101894

(TRADITIONAL)
ATTN: NORMAN F ESTRIN             PHONE NO : 301 279 2899   
9109 COPENHAVER DRIVE             SE DECISION MADE: 21-JAN-11
POTOMAC MD 20854                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)
BIOSENSE WEBSTER, INC.            510(k) NO: K103746

(SPECIAL)
ATTN: WAYNE R HOHMAN              PHONE NO : 909 839 8597   
3333 DIAMOND CANYON RD.           SE DECISION MADE: 21-JAN-11
DIAMOND BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS
THE LAGADO CORP.                  510(k) NO: K102154

(TRADITIONAL)
ATTN: JOHN M SZABOCISK            PHONE NO : 312 553 0828   
203 NORTH WABASH, STE 2208        SE DECISION MADE: 21-JAN-11
CHICAGO IL 60601                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
EXACTECH, INC.                    510(k) NO: K102870

(TRADITIONAL)
ATTN: VLADISLAVA  ZAITSEVA        PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 21-JAN-11
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HAMILTON-C2
HAMILTON MEDICAL AG               510(k) NO: K102775

(TRADITIONAL)
ATTN: JOERG  SCHNEIDER            PHONE NO : 41 81 6606010
VIA CRUSCH 8                      SE DECISION MADE: 21-JAN-11
BONADUZ    SZ CH-7402             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIAISON XL ANALYZER MODEL 10050
DIASORIN, INC.                    510(k) NO: K103529

(TRADITIONAL)
ATTN: MARI  MEYER                 PHONE NO : 651 351 5635   
195 NORTHWESTERN AVE. P.O. BOX 285SE DECISION MADE: 21-JAN-11
STILLWATER MN 55082               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GRANDIO SO FLOW
VOCO GMBH                         510(k) NO: K103580

(SPECIAL)
ATTN: MANFRED THOMAS  PLAUMANN    PHONE NO : 494 721 7190
ANTON-FLETTNER-STRASSE 1-3        SE DECISION MADE: 21-JAN-11
CUXHAVEN    GM D-27472            510(k) STATEMENT

DEVICE: COMPACT PIEZO P2K, POWERCARE
MECTRON S.P.A.                    510(k) NO: K102218

(TRADITIONAL)
ATTN: ROGER  GRAY                 PHONE NO : 390 657 82665
PIAZZA ALBANIA 10                 SE DECISION MADE: 24-JAN-11
ROME    IT 00153                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WOUND PRO APEX
ACCURO MEDICAL PRODUCTS LLC       510(k) NO: K100823

(TRADITIONAL)
ATTN: TODD  HUBBARD               PHONE NO : 630 829 1675   
3879 EAST 120TH AVE SUITE 328     SE DECISION MADE: 24-JAN-11
DENVER CO 80233                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SORBACT
ABIGO MEDICAL AB                  510(k) NO: K100591

(TRADITIONAL)
ATTN: CONSTANCE  BUNDY            PHONE NO : 763 574 1976   
435 RICE CREEK TERRACE NE,        SE DECISION MADE: 24-JAN-11
FRIDLEY MN 55432                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V
VASCULAR SOLUTIONS, INC.          510(k) NO: K101604

(TRADITIONAL)
ATTN: JENNIFER  RUETHER           PHONE NO : 763 656 4300   
6464 SYCAMORE COURT               SE DECISION MADE: 24-JAN-11
MINNEAPOLIS MN 55369              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KYPHON INFLATION SYRINGE
MEDTRONIC SPINE LLC               510(k) NO: K103231

(TRADITIONAL)
ATTN: HETAL  JAWAHAR THAKKER      PHONE NO : 408 548 6500   
1221 CROSSMAN AVE.                SE DECISION MADE: 24-JAN-11
SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIZION DR
VIZTEK, INC.                      510(k) NO: K102123

(TRADITIONAL)
ATTN: DANIEL  KAMM, P.E.          PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 24-JAN-11
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE
ANGSTROM MFG., INC.               510(k) NO: K103157

(TRADITIONAL)
ATTN: CHRIS  CARRON               PHONE NO : 573 483 3773   
6539 U.S. HWY. 61                 SE DECISION MADE: 24-JAN-11
BLOOMSDALE MO 63627               510(k) STATEMENT

DEVICE: RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K102336

(TRADITIONAL)
ATTN: ASHLEY  PYLE                PHONE NO : 508 683 4359
2546 FIRST STREET, PROPARK        SE DECISION MADE: 24-JAN-11
ALAJUELA    CS                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOTAL SHOULDER SYSTEM
SHOULDER INNOVATIONS, LLC         510(k) NO: K102670

(TRADITIONAL)
ATTN: ANDREW  RODENHOUSE          PHONE NO : 616 706 3903   
4670 FULTON STREET EAST SUITE 202 SE DECISION MADE: 24-JAN-11
ADA MI 49301                      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APTUS ULNA PLATES
MEDARTIS AG                       510(k) NO: K103332

(TRADITIONAL)
ATTN: KEVIN A THOMAS              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL, SUITE 200   SE DECISION MADE: 24-JAN-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE
FUJIREBIO DIAGNOSTICS, INC        510(k) NO: K103450

(TRADITIONAL)
ATTN: KENT  PRUETT                PHONE NO : 830 372 1391   
940 CROSSROADS BLVD.              SE DECISION MADE: 25-JAN-11
SEGUIN TX 78155                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLUORCANASITE DENTAL CERAMIC
DR SARAH POLLINGTON               510(k) NO: K100794

(TRADITIONAL)
ATTN: JUDY  BURTON                PHONE NO : 972 243 5105   
3010 LBJ FRWY 12TH FLOOR          SE DECISION MADE: 25-JAN-11
DALLAS TX 75234                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORAL FLUID PHENCYCLIDINE
ROCHE DIAGNOSTICS                 510(k) NO: K093989

(TRADITIONAL)
ATTN: MICHELLE  LEE NEFF          PHONE NO : 317 521 2000   
9115 HAGUE ROAD PO BOX 50416      SE DECISION MADE: 25-JAN-11
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURECALL EMG LABOR MONITOR
REPRODUCTIVE RESEARCH TECHNOLOGIES510(k) NO: K090145

(TRADITIONAL)
ATTN: J. HARVEY  KNAUSS           PHONE NO : 713 723 4080   
11874 SOUTH EVELYN                SE DECISION MADE: 25-JAN-11
HOUSTON TX 77071                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOVITA PEEK SPACER
ORTHOVITA, INC.                   510(k) NO: K101171

(TRADITIONAL)
ATTN: CATHERINE V MOFFA           PHONE NO : 610 640 1775   
45 GREAT VALLEY PKWY.             SE DECISION MADE: 25-JAN-11
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CEROX, MODEL 321OF
OR-NIM MEDICAL LTD.               510(k) NO: K100875

(TRADITIONAL)
ATTN: MICHAL  BALBERG             PHONE NO : 972 892 82801
1 YODFAT ST                       SE DECISION MADE: 25-JAN-11
LOD    IS 71291                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIATRON PICTUS 400
DIATRON GROUP                     510(k) NO: K101741

(TRADITIONAL)
ATTN: JIM  SCHEPP                 PHONE NO : 954 614 8493   
2545 MONTCLAIRE CIRCLE            SE DECISION MADE: 25-JAN-11
WESTO FL 33327                    510(k) STATEMENT

DEVICE: ORTHODONTIC CERAMIC BRACKET
HT CO., LTD.                      510(k) NO: K102561

(TRADITIONAL)
ATTN: JERRY  CHOI                 PHONE NO : 823 140 03932
HBI 527, HANYANG UNIV. 1271 SA 1(ISE DECISION MADE: 25-JAN-11
ANSAN-SI, GYEONGGI-DO    KS 426-79510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MSC LIPID CONTROL
MAINE STANDARDS CO.               510(k) NO: K103271

(TRADITIONAL)
ATTN: HOLLY  CRESSMAN             PHONE NO : 207 892 1300   
765 ROOSEVELT TRAIL               SE DECISION MADE: 25-JAN-11
WINDHAM ME 04062 5365             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER
AKTINA MEDICAL PHYSICS CORP.      510(k) NO: K103616

(TRADITIONAL)
ATTN: TONY  SPACCAROTELLA         PHONE NO : 845 268 0101   
360 NORTH ROUTE 9W                SE DECISION MADE: 25-JAN-11
CONGERS NY 10920                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION VISA ENZ 2 CAL
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K103612

(TRADITIONAL)
ATTN: ANNA MARIE K ENNIS          PHONE NO : 302 631 9352   
500 GBC DRIVE P.O. BOX 6101       SE DECISION MADE: 25-JAN-11
NEWARK DE 19714 6101              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TIGER FLAT SURGICAL MASK
TIGER MEDICAL PRODUCTS LTD        510(k) NO: K102713

(ABBREVIATED)
ATTN: MAGGIE  ZHONG               PHONE NO : 862 133 907930
LIULIN TOWER, STE 1910, 1 HUAI HAISE DECISION MADE: 25-JAN-11
SHANGHAI    CH 200021             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1
PROMIMIC AB                       510(k) NO: K101225

(TRADITIONAL)
ATTN: KARIN  BREDING              PHONE NO : 463 177 28035
STENA CENTER 1B                   SE DECISION MADE: 25-JAN-11
GOTEBORG    SW SE-412 92          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LITECURE THERAPY SYSTEM
LITECURE, LLC                     510(k) NO: K103511

(SPECIAL)
ATTN: LIANG  LU                   PHONE NO : 302 709 0408   
250 CORPORATE BLVD., SUITE B      SE DECISION MADE: 25-JAN-11
NEWARK DE 19702                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHEETAH RELIANT
CHEETAH MEDICAL INC.              510(k) NO: K103166

(ABBREVIATED)
ATTN: RHONA  SHANKER              PHONE NO : 301 251 9570   
12154 DARNESTOWN RD. #236         SE DECISION MADE: 25-JAN-11
GAITHERSBURG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LAMENCO SPINAL FIXATION SYSTEM
ULRICH GMBH & CO. KG              510(k) NO: K102853

(TRADITIONAL)
ATTN: HANS  STOVER                PHONE NO : 636 519 0268   
754 SPIRIT 40 PARK DRIVE          SE DECISION MADE: 25-JAN-11
CHESTERFIELD MO 63005             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE
MEDICAL WIRE & EQUIPMENT COMPANY (510(k) NO: K103805

(SPECIAL)
ATTN: DAVID  ELLIS                PHONE NO : 441 225 810361
POTLEY LANE                       SE DECISION MADE: 25-JAN-11
CORSHAM, WILTSHIRE    UK SN13 9RT 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Q-STATION
PHILIPS ULTRASOUND, INC.          510(k) NO: K103815

(TRADITIONAL)
ATTN: NANCY P BURKE               PHONE NO : 425 487 7371   
P.O. BOX 3003                     SE DECISION MADE: 25-JAN-11
BOTHELL WA 98021 3003             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: KOWA NONMYD WX
KOWA CO. LTD.                     510(k) NO: K101628

(TRADITIONAL)
ATTN: SATOHIKO  TAKANASHI         PHONE NO : 813 327 97646
4-14, NIHONBASHI-HONCHO 3-CHOME   SE DECISION MADE: 26-JAN-11
CHUO-KU, TOKYO    JA 103-8433     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERSR ELECTROMYOGRAPHY SYSTEM
SPINEMATRIX, INC.                 510(k) NO: K110048

(SPECIAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET STREET 29TH FLOOR     SE DECISION MADE: 26-JAN-11
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
ADVANCED SURGICAL CONCEPTS        510(k) NO: K110004

(SPECIAL)
ATTN: JONATHAN  KAHAN             PHONE NO : 202 637 5794   
355 THIRTEENTH STREET, NW         SE DECISION MADE: 26-JAN-11
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE BLOOD PRESSURE CUF
CAREMATE MEDICAL DEVICE CO., LTD  510(k) NO: K102792

(TRADITIONAL)
ATTN: LEE  FU                     PHONE NO : 86 21 64264467
P.O. BOX 237-023                  SE DECISION MADE: 26-JAN-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS
KAZ USA, INC (A SUBSIDIARY OF KAZ 510(k) NO: K103800

(SPECIAL)
ATTN: RAJ  KASBEKAR               PHONE NO : 508 490 7280   
250 TURNPIKE ROAD                 SE DECISION MADE: 26-JAN-11
SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STAYHEALTHY BODY COMPOSITION MONITOR-BCM
STAYHEALTHY, INC.                 510(k) NO: K101807

(TRADITIONAL)
ATTN: JESUS  FARINAS              PHONE NO : 626 256 6152   
724 E. HUNTINGTON DRIVE           SE DECISION MADE: 26-JAN-11
MONROVIA CA 91016                 510(k) STATEMENT

DEVICE: CONSENSUS KNEE SYSTEM
CONSENSUS ORTHOPEDICS, INC        510(k) NO: K102927

(TRADITIONAL)
ATTN: MATTHEW  HULL               PHONE NO : 916 355 7100   
1115 WINFIELD WAY SUITE 100       SE DECISION MADE: 26-JAN-11
EL DORADO HILLS CA 95762 9623     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREQUENCER
DYMEDSO INC.                      510(k) NO: K103176

(TRADITIONAL)
ATTN: JEAN  BIGONEY               PHONE NO : 802 885 8026   
127 MAIN ST. PO BOX 826           SE DECISION MADE: 26-JAN-11
SPRINGFIELD VT 05156 0826         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VANTAGE VIEW SYSTEM
ST. JUDE MEDICAL                  510(k) NO: K110085

(TRADITIONAL)
ATTN: KRIS  MILLER                PHONE NO : 
ONE ST JUDE MEDICAL DRIVE         SE DECISION MADE: 26-JAN-11
ST PAUL MN 55117 9913             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MODEL LTV 1100 VENTILATOR
CAREFUSION                        510(k) NO: K101643

(TRADITIONAL)
ATTN: MONTHER  ABUSHABAN          PHONE NO : 714 919 3660   
22745 SAVI RANCH PARKWAY          SE DECISION MADE: 26-JAN-11
YORBA LINDA CA 92887              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEODENT IMPLANT SYSTEM
JJGC INDUSTRIA E COMERCIO DE MATER510(k) NO: K101945

(TRADITIONAL)
ATTN: LINDA K SCHULZ              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 26-JAN-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA
SURGIVISION, INC.                 510(k) NO: K102101

(TRADITIONAL)
ATTN: EDWARD  WADDELL             PHONE NO : 949 900 6833   
5 MUSICK                          SE DECISION MADE: 26-JAN-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K102886

(TRADITIONAL)
ATTN: LEE  GRANT                  PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 26-JAN-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO
MICRUS ENDOVASCULAR CORPORATION   510(k) NO: K103780

(SPECIAL)
ATTN: PATRICK  LEE                PHONE NO : 408 433 1428   
821 FOX LANE                      SE DECISION MADE: 26-JAN-11
SAN JOSE CA 95131                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PENUMBRA EMBOLIZATION COIL SYSTEM
PENUMBRA, INC.                    510(k) NO: K103305

(TRADITIONAL)
ATTN: SETH A SCHULMAN             PHONE NO : 510 748 3200   
1351 HARBOR BAY PARKWAY           SE DECISION MADE: 26-JAN-11
ALAMEDA CA 94502                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEFORTE NEURO SYSTEM BONE PLATE
JEIL MEDICAL CORPORATION          510(k) NO: K103778(SPECIAL)
ATTN: PAUL  SUMNER                PHONE NO : 770 448 7529   
5966 EXETER CIRCLE                SE DECISION MADE: 26-JAN-11
NORCROSS GA 30071                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMNIVISION
MODERN MODULE INC                 510(k) NO: K110040

(TRADITIONAL)
ATTN: SAMUEL  KOH                 PHONE NO : 823 262 36721
425 CHEONGCHUN-DONG, BUPYUNG-KU   SE DECISION MADE: 26-JAN-11
LNCHEON    KS                     510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM
WILDCAT MEDICAL INC               510(k) NO: K103187

(TRADITIONAL)
ATTN: JOE  ADKINS                 PHONE NO : 216 849 7847   
284 RIDGE ROAD                    SE DECISION MADE: 26-JAN-11
HINCKLEY OH 44233                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEDECAL
SEDECAL S.A.                      510(k) NO: K103522

(SPECIAL)
ATTN: DANIEL  KAMM, P.E.          PHONE NO : 239 234 1735   
8870 RAVELLO                      SE DECISION MADE: 26-JAN-11
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLUID FILLED TEETHER - GEL
KIDS II                           510(k) NO: K092025

(ABBREVIATED)
ATTN: BOB  COUGHLIN               PHONE NO : 770 751 0442   
555 NORTH POINT CENTER SUITE 600  SE DECISION MADE: 27-JAN-11
ALPHARETTA GA 30022               510(k) STATEMENT

DEVICE: VENTLAB 6000 SERIES HUMIDIFIER
VENTLAB CORP.                     510(k) NO: K093617

(TRADITIONAL)
ATTN: JAMES A COCHIE              PHONE NO : 336 753 5000   
155 BOYCE DRIVE                   SE DECISION MADE: 27-JAN-11
MOCKSVILLE NC 27028               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GC ORAL MOISTURIZING GEL
GC AMERICA, INC.                  510(k) NO: K101346

(TRADITIONAL)
ATTN: MARK  HEISS                 PHONE NO : 708 897 4042   
3737 W. 127TH ST.                 SE DECISION MADE: 27-JAN-11
ALSIP IL 60803                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770
SMITH & NEPHEW, INC.              510(k) NO: K101459

(TRADITIONAL)
ATTN: JULIE  ACKER                PHONE NO : 978 749 1000   
150 MINUTEMAN RD.                 SE DECISION MADE: 27-JAN-11
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004
SPS MEDICAL SUPPLY CORP.          510(k) NO: K102363(TRADITIONAL)
ATTN: GARY J SOCOLA               PHONE NO : 585 359 0130   
6789 WEST HENRIETTA RD.           SE DECISION MADE: 27-JAN-11
RUSH NY 14543                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
SYNTHES USA PRODUCTS LLC          510(k) NO: K102722

(TRADITIONAL)
ATTN: JEFFREY L DOW, JD           PHONE NO : 484 356 9720   
1230 WILSON DRIVE                 SE DECISION MADE: 27-JAN-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REDONDO-L
SEASPINE, INC.                    510(k) NO: K103297

(SPECIAL)
ATTN: ETHEL  BERNAL               PHONE NO : 760 727 8399   
2302 LA MIRADA DR.                SE DECISION MADE: 27-JAN-11
VISTA CA 92081 7862               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 4D MV-ASSESSMENT 2.0
TOMTEC IMAGING SYSTEMS, GMBH      510(k) NO: K103782

(SPECIAL)
ATTN: INGE  SCHEIDT               PHONE NO : 498 932 175515
EDISONSTRASSE 6                   SE DECISION MADE: 27-JAN-11
UNTERSCHLEISSHEIM    GM D-85716   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FISIO CHAMBER SPACE
KOO(SHANGHAI)INDUSTRIES CO., LTD. 510(k) NO: K101136

(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 28-JAN-11
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,
LIMA-LTO S.P.A.                   510(k) NO: K101263

(TRADITIONAL)
ATTN: CHERYL  HASTINGS            PHONE NO : 574 527 4220   
PO BOX 696                        SE DECISION MADE: 28-JAN-11
WINONA LAKE IN 46590              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAMMAPRINT
AGENDIA                           510(k) NO: K101454

(TRADITIONAL)
ATTN: GUIDO  BRINK                PHONE NO : 
SCIENCE PARK 406                  SE DECISION MADE: 28-JAN-11
AMSTERDAM    NL 1098SM            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMA SCREEN ER
IMMUNOSTICS, INC.                 510(k) NO: K102664

(SPECIAL)
ATTN: RICHARD M PEOPLES           PHONE NO : 732 918 0770   
3505 SUNSET AVE.                  SE DECISION MADE: 28-JAN-11
OCEAN NJ 07712                    510(k) STATEMENT

DEVICE: NEUCOLONCARE
NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K110077

(TRADITIONAL)
ATTN: TIAN  YEUHUI                PHONE NO : 862 483 660646
NO. 16, SHIJI ROAD HUNNAN INDUSRTISE DECISION MADE: 28-JAN-11
SHENYANG, LIAONING    CH 110179   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
AMBU A/S                          510(k) NO: K102824

(ABBREVIATED)
ATTN: SANJAY  PARIKH              PHONE NO : 410 768 6464   
6740 BAYMEADOW DR.                SE DECISION MADE: 28-JAN-11
GLEN BURNIE MD 21060              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENTICARE PILLSTATION
SENTICARE, INC.                   510(k) NO: K103009

(TRADITIONAL)
ATTN: SETH A MAILHOT              PHONE NO : 202 585 8196   
401 9TH STREET NW SUITE 900       SE DECISION MADE: 28-JAN-11
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIRADRY SYSTEM
MIRAMAR LABS, INC.                510(k) NO: K103014

(TRADITIONAL)
ATTN: KATHY  O'SHAUGHNESSY        PHONE NO : 408 940 8700   
445 INDIO WAY                     SE DECISION MADE: 28-JAN-11
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANS SYSTEM
CAIRD TECHNOLOGY                  510(k) NO: K101016(TRADITIONAL)
ATTN: JAMES H BROWN               PHONE NO : 802 237 8175   
205 CAMDEN CHASE                  SE DECISION MADE: 28-JAN-11
COLUMBIA SC 29223                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR
ADVANCED STERILIZATION PRODUCTS   510(k) NO: K102884

(TRADITIONAL)
ATTN: KEVIN  CORRIGAN             PHONE NO : 949 453 6410   
33 TECHNOLOGY DR.                 SE DECISION MADE: 28-JAN-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLSTICE
KERR CORPORATION                  510(k) NO: K102621

(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602   
1717 WEST COLLINS AVENUE          SE DECISION MADE: 28-JAN-11
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008
WON INDUSTRIAL CO.                510(k) NO: K102319

(TRADITIONAL)
ATTN: BRANDON  CHOI               PHONE NO : 714 523 1592   
49 CANDLEWOOD WAY                 SE DECISION MADE: 28-JAN-11
BUENA PARK CA 90621               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K103677
(TRADITIONAL)
ATTN: ZHAI  PEI                   PHONE NO : 867 552 6582551
BLDG.A3,HONG HUA LING IND.PARK NORSE DECISION MADE: 31-JAN-11
NANSHAN,SHENZHEN, GUANGDONG    CH 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: COR ANALYZER
RCADIA MEDICAL IMAGING LTD.       510(k) NO: K110071

(SPECIAL)
ATTN: DAN  LAOR                   PHONE NO : 972 4 8246632
6 SIRENI                          SE DECISION MADE: 31-JAN-11
HAIFA    IS 32972                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
COLOPLAST A/S                     510(k) NO: K103254

(TRADITIONAL)
ATTN: BRIAN  SCHMIDT              PHONE NO : 612 302 4987   
1601 WEST RIVER ROAD NORTH        SE DECISION MADE: 31-JAN-11
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW SMF HIP STEM
SMITH & NEPHEW, INC.              510(k) NO: K103256

(ABBREVIATED)
ATTN: NATALIE P WILLIAMS          PHONE NO : 901 399 5161   
1450 EAST BROOKS RD.              SE DECISION MADE: 31-JAN-11
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEKA SYNCHRO FT
EL.EN. ELECTRONIC ENGINEERING SPA 510(k) NO: K103288

(TRADITIONAL)
ATTN: PAOLO  PERUZZI              PHONE NO : 390 558 826807
17 VIA BALDANZESE                 SE DECISION MADE: 31-JAN-11
CALENZANO    IT 50041             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM
ENCORE MEDICAL, L.P.              510(k) NO: K103208

(TRADITIONAL)
ATTN: TEFFANY  HUTTO              PHONE NO : 512 834 6255   
9800 METRIC BLVD.                 SE DECISION MADE: 31-JAN-11
AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PICCOLO COMPOSITE NAILING SYSTEM
N.M.B. MEDICAL APPLICATIONS, LTD. 510(k) NO: K102369

(TRADITIONAL)
ATTN: YAEL  RUBIN                 PHONE NO : 972 995 11511
11 HA'HOSHLIM STREET              SE DECISION MADE: 31-JAN-11
HARZELIYA    IS 46724             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
TORNIER, INC.                     510(k) NO: K102924

(TRADITIONAL)
ATTN: BRAHIM  HADRI               PHONE NO : 978 232 9997   
100 CUMMINGS CENTER SUITE 444C    SE DECISION MADE: 31-JAN-11
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNAPSE 3D CARDIAC TOOLS
FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K103465

(TRADITIONAL)
ATTN: DEBBIE  PEACOCK             PHONE NO : 203 602 3774   
419 WEST AVE.                     SE DECISION MADE: 31-JAN-11
STAMFORD CT 06902 6300            510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   259                                     
                                                 TOTAL WITH SUMMARIES        242                                     
                                                 TOTAL WITH STATEMENTS        17