Medical Devices

September 2010 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD September 2010


DEVICE: NESSI OTC SPACER
PHARMACARIBE                      510(k) NO: K101532(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 01-SEP-10
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITAL SIGNS MONITOR
CRITICARE SYSTEMS, INC.           510(k) NO: K101602(SPECIAL)

ATTN: ALEX  KAPLAN                PHONE NO : 262 798 8282   
20925 CROSSROADS CIRCLE           SE DECISION MADE: 01-SEP-10
WAUKESHA WI 53186                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUX1540, LUX1440 & LUX2940 LASER HANDPIECES
PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K101506(TRADITIONAL)

ATTN: SHARON  TIMBERLAKE          PHONE NO : 781 993 2414   
15 NETWORK DRIVE                  SE DECISION MADE: 01-SEP-10
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VEGA SPAN SPINOUS PROCESS PLATE SYSTEM
SPINEFRONTIER, INC.               510(k) NO: K102020(TRADITIONAL)

ATTN: JOHN  SULLIVAN              PHONE NO : 978 232 3990   
500 CUMMINGS CENTER, STE. 3500    SE DECISION MADE: 01-SEP-10
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRECICONTROL CLINCHEM MULTI 1 AND 2
ROCHE DIAGNOSTICS                 510(k) NO: K102016(TRADITIONAL)

ATTN: PATRICK J STIMART           PHONE NO : 317 521 3954   
9115 HAGUE ROAD                   SE DECISION MADE: 01-SEP-10
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT
NOVABONE PRODUCTS, LLC            510(k) NO: K101860(SPECIAL)

ATTN: DAVID M GALSSER             PHONE NO : 386 462 7661   
13631 PROGRESS BLVD SUITE 600     SE DECISION MADE: 01-SEP-10
ALACHUA FL 32615                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10
MEDTRONIC CRYOCATH LP             510(k) NO: K102176(SPECIAL)

ATTN: KARI  LAHTI                 PHONE NO : 763 526 1766
16771 CHEMIN STE-MARIE            SE DECISION MADE: 01-SEP-10
KIRKLAND    CA H9H5H3             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EUROIMMUN ANTI-M2-3E ELISA (IGG)
EUROIMMUN US INC                  510(k) NO: K092736(TRADITIONAL)

ATTN: KATHRYN  KOHL               PHONE NO : 973 270 0912   
95 WASHINGTON ST                  SE DECISION MADE: 02-SEP-10
MORRISTOWN NJ 07960               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)
EUROIMMUN US INC                  510(k) NO: K091969(TRADITIONAL)

ATTN: KATHRYN  KOHL               PHONE NO : 973 270 0912   
95 WASHINGTON ST                  SE DECISION MADE: 02-SEP-10
MORRISTOWN NJ 07960               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.
EXACTECH, INC.                    510(k) NO: K093430(TRADITIONAL)
ATTN: GRAHAM  CUTHBERT            PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 02-SEP-10
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING
SMITH & NEPHEW, INC.              510(k) NO: K100795(TRADITIONAL)
ATTN: SHEREEN  MYERS              PHONE NO : 901 399 6325   
1450 EAST BROOKS RD.              SE DECISION MADE: 02-SEP-10
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VU APOD INTERVERTEBRAL BODY FUSION DEVICE
THEKEN SPINE LLC                  510(k) NO: K101310(TRADITIONAL)

ATTN: GLENN  STIEGMAN             PHONE NO : 202 552 5800   
1331 H STREET NW, 12TH FLOOR      SE DECISION MADE: 02-SEP-10
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHARPS CONTAINER
CIXI LEINUO PLASTIC CO. LTD       510(k) NO: K101567(TRADITIONAL)

ATTN: CHARLES  MACK               PHONE NO : 541 376 5063   
NO. 56 LUOMING SOUTH ROAD GUANHAIWSE DECISION MADE: 02-SEP-10
NINGBO    CH 315316               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK
RESPIRONICS, INC.                 510(k) NO: K101130(SPECIAL)

ATTN: ZITA A YURKO                PHONE NO : 724 387 4120   
1740 GOLDEN MILE HIGHWAY          SE DECISION MADE: 02-SEP-10
MONROEVILLE PA 15146              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIOX MINO MODEL 09-1000
AEROCRINE AB                      510(k) NO: K101034(SPECIAL)

ATTN: JOHANNA  KARLING            PHONE NO : 468 629 0780
SUNDBYBERGSVAGEN 9 P.O. BOX 1024  SE DECISION MADE: 02-SEP-10
SOLNA    SW SE-17121              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NMI IC
NAVILYST MEDICAL, INC.            510(k) NO: K101326(ABBREVIATED)

ATTN: NICHOLAS  CONDAKES          PHONE NO : 508 658 7931   
26 FOREST STREET                  SE DECISION MADE: 02-SEP-10
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASY TOUCH
MHC MEDICAL PRODUCTS              510(k) NO: K102178(SPECIAL)

ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 02-SEP-10
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2
VERILUX                           510(k) NO: K091125(TRADITIONAL)

ATTN: RYAN  DOUGLAS               PHONE NO : 651 203 2100   
391 BRIDGE POINT DR.              SE DECISION MADE: 03-SEP-10
SOUTH ST. PAUL MN 55075           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRUISER 18 GUIDEWIRE
BRIVANT, LTD.                     510(k) NO: K102211(SPECIAL)

ATTN: TOMAS  FUREY                PHONE NO : 353 91 385037
PARKMORE WEST BUSINESS PARK       SE DECISION MADE: 03-SEP-10
GALWAY, COUNTY GALWAY    EI       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5
AALTO SCIENTIFIC LTD.             510(k) NO: K100718(TRADITIONAL)

ATTN: BRANDON J PEREZ             PHONE NO : 760 431 7922   
1959 KELLOGG AVE.                 SE DECISION MADE: 03-SEP-10
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE
COVIDIEN                          510(k) NO: K100418(TRADITIONAL)

ATTN: WING  NG                    PHONE NO : 508 261 6596   
15 HAMPSHIRE STREET               SE DECISION MADE: 03-SEP-10
MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPAPLUS ANALYZER
THE BINDING SITE                  510(k) NO: K100455(TRADITIONAL)

ATTN: JAY  GELLER                 PHONE NO : 310 979 9966   
12100 WILSHIRE BLVD SUITE 500     SE DECISION MADE: 03-SEP-10
LOS ANGELES CA 90025              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
MEDTRONIC PERFUSION SYSTEMS       510(k) NO: K101186(TRADITIONAL)
ATTN: CARALEE  WALTON             PHONE NO : 763 514 9851   
7611 NORTHLAND DR.                SE DECISION MADE: 03-SEP-10
MINNEAPOLIS MN 55432              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAPERLOC COMPLETE
BIOMET, INC.                      510(k) NO: K101086(TRADITIONAL)
ATTN: GARY  BAKER                 PHONE NO : 574 267 6639   
56 EAST BELL DR. P.O. BOX 587     SE DECISION MADE: 03-SEP-10
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL
EXACT MEDICAL MANUFACTURING, INC  510(k) NO: K101593(TRADITIONAL)

ATTN: ROBERT O DEAN               PHONE NO : 716 440 7362   
1083 DELAWARE AVE                 SE DECISION MADE: 03-SEP-10
BUFFALO NY 14209                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROMIAPEX MODEL A-15
ROMIDAN LTD                       510(k) NO: K101054(TRADITIONAL)

ATTN: EITAN  MARGALIT             PHONE NO : 972 373 60099
5 SIMCHA HOLZBERG ST.             SE DECISION MADE: 03-SEP-10
KIRYAT-ONO    IS 55022            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOGRAPH MCT FAMILY
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K101550(TRADITIONAL)

ATTN: ALAINE  MEDIO               PHONE NO : 865 218 2703   
810 INNOVATION DR.                SE DECISION MADE: 03-SEP-10
KNOXVILLE TN 37932                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSSTAPLE CHILL
BIOMEDICAL ENT., INC.             510(k) NO: K102107(SPECIAL)

ATTN: JOE W SOWARD                PHONE NO : 210 677 0354   
14785 OMICRON DR., SUITE 205      SE DECISION MADE: 03-SEP-10
SAN ANTONIO TX 78245              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECLIPSE TREATMENT PLANNING SYSTEM
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K102011(TRADITIONAL)

ATTN: VY  TRAN                    PHONE NO : 650 424 5731   
3100 HANSEN WAY                   SE DECISION MADE: 03-SEP-10
PALO ALTO CA 94304                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE
WEAR SAFE (MALAYSIA) SDN. BHD.    510(k) NO: K101799(TRADITIONAL)

ATTN: MOHD  AZLAN                 PHONE NO : 603 329 23088
LOT PT 13726,JALAN HAJI SALLEH OFFSE DECISION MADE: 03-SEP-10
KLANG,  SELANGOR DARUL EHSAN    MY510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM
3M COMPANY                        510(k) NO: K101834(TRADITIONAL)

ATTN: JIZHONG  JIN                PHONE NO : 651 733 6655   
3M CENTER, BLDG. 275-05-W-06      SE DECISION MADE: 03-SEP-10
ST. PAUL MN 55144 1000            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM
SURGICAL INNOVATIONS GROUP PLC    510(k) NO: K100442(TRADITIONAL)

ATTN: MIKE  WHITE                 PHONE NO : 440 113 2307597
CLAYTON WOOD HOUSE 6 CLAYTON WOOD SE DECISION MADE: 07-SEP-10
LEEDS WEST YORKSHIRE    UK LS16,6Q510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL
HERAEUS KULZER, LLC               510(k) NO: K101617(TRADITIONAL)

ATTN: CHERYL  ZIMMERMAN           PHONE NO : 574 299 5444   
300 HERAEUS WAY                   SE DECISION MADE: 07-SEP-10
SOUTH BEND IN 46614               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE
PT. SMART GLOVE INDONESIA         510(k) NO: K101630(TRADITIONAL)

ATTN: CHO SOW  FONG               PHONE NO : 626 179 40100
JL RAYA MEDAN-LUBUK PAKAM KM19 TANSE DECISION MADE: 07-SEP-10
MORAWA,DELI SERDANG,SUMATERA U    510(k) STATEMENT

DEVICE: MERIT BIPOLAR COAGULATION PROBE
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K102273(SPECIAL)

ATTN: DAN W LINDSAY               PHONE NO : 801 208 4408   
1600 WEST MERIT PKWY.             SE DECISION MADE: 07-SEP-10
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-ABLATIVE WRINKLE TREATMENT HANDPIECE
ELLMAN INT'L INC.                 510(k) NO: K102368(SPECIAL)

ATTN: JONATHAN  ACHENBACH         PHONE NO : 763 257 7125   
3333 ROYAL AVENUE                 SE DECISION MADE: 07-SEP-10
OCEANSIDE NY 11572 3625           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 6F ENGAGE/ENGAGE TR INTRODUCER
ST. JUDE MEDICAL                  510(k) NO: K101883(SPECIAL)

ATTN: VENKATA  DAMARAJU           PHONE NO : 651 756 3259   
14901 DEVEAU PL.                  SE DECISION MADE: 07-SEP-10
MINNETONKA MN 55345 2126          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K101868(SPECIAL)

ATTN: PAUL  BIGGINS               PHONE NO : 714 730 5000   
2441 MICHELLE DR                  SE DECISION MADE: 07-SEP-10
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE:  EMS MINIMASTER LED
EMS ELECTRO MEDICAL SYSTEMS SA    510(k) NO: K093723(TRADITIONAL)

ATTN: CYNTHIA  J.M. NOLTE         PHONE NO : 919 859 4207   
49 PLAIN ST.                      SE DECISION MADE: 08-SEP-10
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HANDHELD PULSE OXIMETER MODEL M800
GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K101694(SPECIAL)

ATTN: DIANA  HONG                 PHONE NO : 862 164 264467
SUITE 5D, NO. 19, LANE 999 ZHONGSHSE DECISION MADE: 08-SEP-10
SHANGHAI    CH 200030             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
ROCHE DIAGNOSTICS                 510(k) NO: K101456(SPECIAL)

ATTN: SUSAN  HOLLANDBECK          PHONE NO : 317 521 3380   
9115 HAGUE ROAD                   SE DECISION MADE: 08-SEP-10
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US
THERMAGE, INC.                    510(k) NO: K101490(TRADITIONAL)

ATTN: KRISS  FOSS                 PHONE NO : 510 780 4657   
25881 INDUSTRIAL BLVD.            SE DECISION MADE: 08-SEP-10
HAYWARD CA 94545                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERIGAGE MODEL 1243RA, 1243RB, 1243RE
3M COMPANY                        510(k) NO: K101249(TRADITIONAL)

ATTN: SUZANNE  LEUNG              PHONE NO : 651 575 8052   
3M CENTER, BLDG. 275-05-W-06      SE DECISION MADE: 08-SEP-10
ST. PAUL MN 55144 1000            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR
SGMP CO., LTD.                    510(k) NO: K101646(TRADITIONAL)

ATTN: JANNA P TUCKER              PHONE NO : 775 342 2612   
198 AVENUE DE LA D'EMERALD        SE DECISION MADE: 08-SEP-10
SPARKS NV 89434                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SNORE GUARD ADVANCE
RANIR LLC                         510(k) NO: K102118(SPECIAL)

ATTN: GERARD J PRUD'HOMME         PHONE NO : 202 637 5735   
555 THIRTEENTH STREET, NW         SE DECISION MADE: 08-SEP-10
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES
VISIONSCOPE TECHNOLOGIES, LLC     510(k) NO: K101734(TRADITIONAL)

ATTN: LIM  CHEUNG PH.D            PHONE NO : 978 776 9512   
2352 MAIN STREET SUITE 303        SE DECISION MADE: 08-SEP-10
CONCORD MA 01742                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12" STERILE PAIRS
KIMBERLY-CLARK CORP.              510(k) NO: K102032(TRADITIONAL)

ATTN: LESTER F PADILLA            PHONE NO : 678 352 6766   
1400 HOLCOMB BRIDGE RD.           SE DECISION MADE: 08-SEP-10
ROSWELL GA 30076                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: COBAS 8000 MODULAR SERIES ANALYZER
ROCHE DIAGNOSTICS CORP.           510(k) NO: K100853(SPECIAL)

ATTN: ANGELO  PEREIRA             PHONE NO : 317 521 3544   
9115 HAGUE RD.                    SE DECISION MADE: 09-SEP-10
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K100985(TRADITIONAL)

ATTN: MICHAEL  DAVIS              PHONE NO : 205 967 7880   
2300 RIVERCHASE CENTER            SE DECISION MADE: 09-SEP-10
BIRMINGHAM AL 35244               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M
DELMA MEDICAL INSTRUMENT (GUANGZHO510(k) NO: K101551(TRADITIONAL)

ATTN: LEON  LU                    PHONE NO : 302 857 0008   
3500 SOUTH DUPONT HIGHWAY         SE DECISION MADE: 09-SEP-10
DOVER DE 19901                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDTRONIC C315 DELIVERY CATHETER
MEDTRONIC INC.                    510(k) NO: K101885(SPECIAL)

ATTN: BRUCE  BACKLUND             PHONE NO : 763 526 0603   
8200 CORAL SEA STREET NE MS MV S11SE DECISION MADE: 09-SEP-10
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACTA VESSEL OCCLUSION SYSTEM (VOS)
NFOCUS NEUROMEDICAL, INC.         510(k) NO: K091952(ABBREVIATED)

ATTN: BOB  O'HOLLA                PHONE NO : 908 337 8478   
2191 E. BAYSHORE ROAD SUITE 100   SE DECISION MADE: 10-SEP-10
PALO ALTO CA 94303                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDEAVOUR MONITORING SYSTEM
MINDRAY DS USA, INC.              510(k) NO: K102004(ABBREVIATED)
ATTN: RUSSELL  OLSEN              PHONE NO : 201 995 8391   
800 MACARTHUR BLVD                SE DECISION MADE: 10-SEP-10
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGICAL FACE MASK
EPARD PROTECTIVE PRODUCTS, LTD    510(k) NO: K093901(TRADITIONAL)

ATTN: DARREN  REEVES              PHONE NO : 804 307 7706   
15637 FOX COVE CIRCLE             SE DECISION MADE: 10-SEP-10
MOSELEY VA 23120                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STLASE DIODE LASER
DENTAL PHOTONICS, INC             510(k) NO: K094049(TRADITIONAL)

ATTN: MARCY  MOORE                PHONE NO : 919 363 2432   
16 APPLETON ST                    SE DECISION MADE: 10-SEP-10
WALTHAM MA 02453                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KIRSCHNER AND GUIDE WIRES
SMT SCHILLING METALLTECHNIK GMBH  510(k) NO: K100736(TRADITIONAL)

ATTN: ANDRE  WEINGERL             PHONE NO : 049 746 3995413
GRIESWEG 47                       SE DECISION MADE: 10-SEP-10
MUEHLHEIM, BADEN-WURTTEMBERG    GM510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM
ZIMMER, INC.                      510(k) NO: K101696(TRADITIONAL)

ATTN: STEPHEN G MCKELVEY, MA, RAC PHONE NO : 574 372 4944   
P.O. BOX 708                      SE DECISION MADE: 10-SEP-10
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K101425(TRADITIONAL)

ATTN: ELISABETH  WARRINER         PHONE NO : 916 374 3244   
1584 ENTERPRISE BLVD              SE DECISION MADE: 10-SEP-10
WEST SACRAMENTO CA 95691          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STAXX XD SYSTEM
SPINE WAVE, INC.                  510(k) NO: K101288(TRADITIONAL)

ATTN: ROAIDA  RIZKALLAH           PHONE NO : 203 712 1839   
THREE  ENTERPRISE DR. SUITE 210   SE DECISION MADE: 10-SEP-10
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TINA-QUANT ALBUMIN GEN 2
ROCHE DIAGNOSTICS                 510(k) NO: K101203(TRADITIONAL)

ATTN: KATHIE J GOODWIN            PHONE NO : 317 521 3831   
9115 HAGUE RD                     SE DECISION MADE: 10-SEP-10
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS FERRITIN CALCHECK 5
ROCHE DIAGNOSTICS                 510(k) NO: K102267(TRADITIONAL)

ATTN: SARAH  BAUMANN              PHONE NO : 317 521 3952   
9115 HAGUE ROAD                   SE DECISION MADE: 10-SEP-10
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUGARD NITILE GREY COLOR
TERANG NUSA SDN BHD               510(k) NO: K102230(SPECIAL)

ATTN: ROBERT  HILL                PHONE NO : 609 774 7171
1, JALAN 8, PENGKALAN CHEPA 2 IND.SE DECISION MADE: 10-SEP-10
KOTA BHARU, KELANTAN    MY 16100  510(k) STATEMENT

DEVICE: STERILE SALINE SOLUTION
CACHET PHARMACEUTICALS PVT. LTD.  510(k) NO: K093367(TRADITIONAL)

ATTN: SHIVKUMAR  AGRAWAL          PHONE NO : 919 967 655855
415 SHAH NAHAR, WORLI             SE DECISION MADE: 10-SEP-10
MUMBAI    IN 400 018              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET
TYCO ELECTRONICS CORPORATION      510(k) NO: K102430(TRADITIONAL)

ATTN: DENNIS M GILKEY             PHONE NO : 503 673 5027   
10025 SW FREEMAN CT.              SE DECISION MADE: 10-SEP-10
WILSONVILLE OR 97070              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: BLOOD PRESSURE METER, MODEL CH-658
CITIZEN SYSTEMS JAPAN CO., LTD.   510(k) NO: K102303(SPECIAL)

ATTN: NATHAN A BEAVER             PHONE NO : 202 295 4039   
3000 K STREET NW SUITE 600        SE DECISION MADE: 10-SEP-10
WASHINGTON DC 20007 5143          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E.S.O. (ELECTRO SENSOR OXI)
L.D. TECHNOLOGY, LLC              510(k) NO: K102442(TRADITIONAL)

ATTN: ALBERT  MAAREK              PHONE NO : 305 379 9900   
100 N. BISCAYNE BLVD SUITE 500    SE DECISION MADE: 10-SEP-10
MIAMI FL 33132                    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TRANSCORP ACIF SYSTEM
TRANSCORP, INC.                   510(k) NO: K092794(TRADITIONAL)

ATTN: ANDREW  RODENHOUSE          PHONE NO : 616 706 3903   
1000 100TH ST. SW, SUITE F        SE DECISION MADE: 13-SEP-10
BYRON CENTER MI                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM
EUROIMMUN US INC                  510(k) NO: K100017(TRADITIONAL)

ATTN: KATHRYN  KOHL               PHONE NO : 973 270 0912   
95 WASHINGTON ST                  SE DECISION MADE: 13-SEP-10
MORRISTOWN NJ 07960               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARARCH
ORMCO CORP.                       510(k) NO: K101676(TRADITIONAL)

ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602   
1717 WEST COLLINS AVENUE          SE DECISION MADE: 13-SEP-10
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2
KEYMED (MEDICAL & INDUSTRIAL EQUIP510(k) NO: K100899(TRADITIONAL)

ATTN: RON  WARREN                 PHONE NO : 858 753 1961   
11440 WEST BERNARDO DRIVE SUITE 30SE DECISION MADE: 13-SEP-10
SAN DIEGO CA 92127                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RXPEAKFLOW
NOBLE MARKETING                   510(k) NO: K101380(TRADITIONAL)

ATTN: LAURA  LYONS                PHONE NO : 317 569 9500   
11460 N. MERIDIAN ST. SUITE 150   SE DECISION MADE: 13-SEP-10
CARMEL IN 46032                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE
NEW STAR LASERS, INC.             510(k) NO: K101783(TRADITIONAL)

ATTN: NATALIE R VOLLRATH          PHONE NO : 916 677 1900   
9085 FOOTHILLS BLVD.              SE DECISION MADE: 13-SEP-10
ROSEVILLE CA 95747                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712
MOLDEX/METRIC, INC.               510(k) NO: K102173(ABBREVIATED)

ATTN: MARK  MEINECKE              PHONE NO : 310 837 6500   
10111 WEST JEFFERSON BLVD.        SE DECISION MADE: 13-SEP-10
CULVER CITY CA 90232              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER
AMSINO INTERNATIONAL, INC.        510(k) NO: K101824(TRADITIONAL)

ATTN: JESUS  FARINAS              PHONE NO : 909 626 5888   
855 TOWNE CENTER DR.              SE DECISION MADE: 13-SEP-10
POMONA CA 91767                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW INSTRUMENT TRAYS
SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K092551(TRADITIONAL)

ATTN: CHRISTINA  FLORES           PHONE NO : 508 261 3705   
150 MINUTEMAN RD.                 SE DECISION MADE: 14-SEP-10
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ST AIA-PACK CYSTATIN C, MODEL 025217
TOSOH BIOSCIENCE, INC.            510(k) NO: K093960(TRADITIONAL)
ATTN: JUDITH K OGDEN              PHONE NO : 650 636 8112   
6000 SHORELINE COURT SUITE 101    SE DECISION MADE: 14-SEP-10
SOUTH SAN FRANCISCO CA 94080      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK
BIO-RAD, DIAGNOSTICS GRP.         510(k) NO: K100727(TRADITIONAL)

ATTN: SUZANNE  PARSONS            PHONE NO : 949 598 1467   
9500 JERONIMO RD.                 SE DECISION MADE: 14-SEP-10
IRVINE CA 92618 2017              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P
BREDENT GMBH & CO.KG              510(k) NO: K101064(TRADITIONAL)

ATTN: ANDREA  PECSI               PHONE NO : 497 462 924051
SCHWARZWALDSTRASSE 5              SE DECISION MADE: 14-SEP-10
TUTTLINGEN, BAWU    GM 78532      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CABLECAP MODEL: WLF, STZ, ACM
SENSORMED                         510(k) NO: K101496(TRADITIONAL)

ATTN: WILLIAM  MILAM              PHONE NO : 865 216 6307   
2450 EJ CHAPMAN DR., SUITE 104    SE DECISION MADE: 14-SEP-10
KNOXVILLE TN 37996                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAPERED SCREW-VENT T IMPLANT
ZIMMER DENTAL INC.                510(k) NO: K101977(TRADITIONAL)

ATTN: JEREMY  MARKOVICH           PHONE NO : 760 929 4300   
1900 ASTON AVE.                   SE DECISION MADE: 14-SEP-10
CARLSBAD CA 92008 7308            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET
OMNI LIFE SCIENCE, INC.           510(k) NO: K101976(SPECIAL)

ATTN: RADHIKA  PONDICHERRY        PHONE NO : 774 226 1852   
50 O'CONNELL WAY                  SE DECISION MADE: 14-SEP-10
EAST TAUNTON MA 02718             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTELLIWAVE3
ART OPTICAL CONTACT LENS, INC.    510(k) NO: K100221(TRADITIONAL)

ATTN: MARTIN  DALSING             PHONE NO : 970 243 5490   
806 KIMBALL AVENUE                SE DECISION MADE: 14-SEP-10
GRAND JUNCTION CO 81501           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMIX PANORAD AND SOMARAD
IMIX ADR FINLAND OY               510(k) NO: K101435(TRADITIONAL)

ATTN: DANIEL  KAMM, P.E.          PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 15-SEP-10
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEPILEX BORDER AG DRESSING
MOLNLYCKE HEALTH CARE             510(k) NO: K100029(TRADITIONAL)

ATTN: STEVEN  DOWDLEY             PHONE NO : 678 451 8062   
5550 PEACHTREE PARKWAY SUITE 500  SE DECISION MADE: 15-SEP-10
NORCROSS GA 30092                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM
BIOLITEC, INC.                    510(k) NO: K100726(TRADITIONAL)

ATTN: HARRY  HAYES                PHONE NO : 413 250 0779   
1349 MAIN ROAD                    SE DECISION MADE: 15-SEP-10
GRANVILLE MA 01034                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION
ABBOTT MEDICAL OPTICS INC         510(k) NO: K093254(TRADITIONAL)

ATTN: KESLEY E GALLAGHER          PHONE NO : 714 247 8930   
1700 E. ST. ANDREW PLACE          SE DECISION MADE: 15-SEP-10
SANTA ANA CA 92705                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMBRACE
IZI MEDICAL PRODUCTS INC.         510(k) NO: K101373(TRADITIONAL)

ATTN: HELEN  SHAFER               PHONE NO : 410 594 9403   
7020 TUDSBURY RD.                 SE DECISION MADE: 15-SEP-10
BALTIMORE MD 21244                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RTVUE MODEL RTVUE 100
OPTOVUE, INC.                     510(k) NO: K101505(TRADITIONAL)

ATTN: JOHN  TALARICO              PHONE NO : 510 623 8868   
45531 NORTHPORT LOOP W.           SE DECISION MADE: 15-SEP-10
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CEROS TCP GRANULES
MATHYS LTD                        510(k) NO: K101426(TRADITIONAL)

ATTN: LINDA  SCHULZ               PHONE NO : 858 792 1235   
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 15-SEP-10
SAN DIEGO CA 92130 8587           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECO SUPERGEL
CERACARTA SPA                     510(k) NO: K101429(TRADITIONAL)

ATTN: ELAINE  DUNCAN              PHONE NO : 715 549 6035   
P.O. BOX 560                      SE DECISION MADE: 15-SEP-10
STILLWATER MN 55082               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM
SYNTHES (USA) LLC                 510(k) NO: K101536(TRADITIONAL)

ATTN: LISA  GRANEY                PHONE NO : 610 719 1286   
1301 GOSHEN PARKWAY               SE DECISION MADE: 15-SEP-10
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRIMED X-FIX
TRIMED, INC.                      510(k) NO: K101375(TRADITIONAL)

ATTN: KELLI  ANDERSON             PHONE NO : 661 312 7150   
28337 MAITLAND LANE               SE DECISION MADE: 15-SEP-10
SAUGUS CA 91350                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
ST. JUDE MEDICAL                  510(k) NO: K101968(SPECIAL)
ATTN: SUSAN  ENGELSON             PHONE NO : 408 522 6283   
701 EAST EVELYN AVENUE            SE DECISION MADE: 15-SEP-10
SUNNYVALE CA 94086 6527           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
COVIDIEN                          510(k) NO: K102291(TRADITIONAL)

ATTN: TIM M LOHNES                PHONE NO : 203 492 5462   
60 MIDDLETOWN DR                  SE DECISION MADE: 15-SEP-10
NORTH HAVEN CT 06473              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZOLL PROPAQ M
ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K102174(TRADITIONAL)

ATTN: PAUL  DIAS                  PHONE NO : 978 421 9413   
269 MILL ROAD                     SE DECISION MADE: 15-SEP-10
CHELMSFORD MA 01824 4105          510(k) STATEMENT

DEVICE: ITOTAL CR KNEE REPLACEMENT SYSTEM
CONFORMIS, INC.                   510(k) NO: K094050(TRADITIONAL)

ATTN: AMITA S SHAH                PHONE NO : 781 345 9164   
2 FOURTH AVENUE                   SE DECISION MADE: 16-SEP-10
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
RESPIRONICS, INC.                 510(k) NO: K101129(SPECIAL)

ATTN: ZITA A YURKO                PHONE NO : 724 387 4120   
1740 GOLDEN MILE HIGHWAY          SE DECISION MADE: 16-SEP-10
MONROEVILLE PA 15146              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MYRAY HYPERION
CEFLA DENTAL GROUP                510(k) NO: K101661(TRADITIONAL)

ATTN: CYNTHIA J NOLTE, PH.D.      PHONE NO : 919 859 4207   
49 PLAIN STREET                   SE DECISION MADE: 16-SEP-10
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROPATCH SOFT TISSUE REPAIR MATRIX
CRYOLIFE, INC.                    510(k) NO: K101587(TRADITIONAL)

ATTN: BRYAN  BROSSEAU             PHONE NO : 770 419 3355   
1655 ROBERTS BLVD., N.W.          SE DECISION MADE: 16-SEP-10
KENNESAW GA 30144                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BABY QUASAR
SILVER BAY, LLC                   510(k) NO: K091467(TRADITIONAL)

ATTN: DANIEL  KAMM, P.E.          PHONE NO : 847 374 8854   
333 MILFORD ROAD                  SE DECISION MADE: 17-SEP-10
DEERFIELD IL 60015                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM ("V.A.C. ULTA THERAPY SYSTEM") MODEL V.A.C. ULTA THERAPY UNIT MODEL U
KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K100657(TRADITIONAL)

ATTN: MARGARET  MARSH             PHONE NO : 210 255 6481   
6203 FARINON DRIVE                SE DECISION MADE: 17-SEP-10
SAN ANTONIO TX 78249              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
SMITH & NEPHEW, INC.              510(k) NO: K100787(TRADITIONAL)

ATTN: LAURA D REYNOLDS            PHONE NO : 727 329 7702   
970 LAKE CARILLON DR. SUITE 110   SE DECISION MADE: 17-SEP-10
ST. PETERSBURG FL 33716           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVIVATOR
HERSILL, S.L.                     510(k) NO: K094003(ABBREVIATED)

ATTN: ANA MARIA  ROMERO           PHONE NO : 349 161 64111
PUERTO DE NAVACERRADA, 3          SE DECISION MADE: 17-SEP-10
MOSTOLES ( MADRID)    SP 28935    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUTE INNOVATIONS STERNAL FIXATION SYSTEM
ACUTE INNOVATIONS LLC             510(k) NO: K101170(TRADITIONAL)

ATTN: MARIAH  KNIGHT              PHONE NO : 503 686 7200   
21421 NW JACOBSON RD. SUITE 700   SE DECISION MADE: 17-SEP-10
HILLSBORO OR 97124                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GC FUJI TEMP
GC AMERICA, INC.                  510(k) NO: K101420(TRADITIONAL)

ATTN: MARK  HEISS                 PHONE NO : 708 897 4042   
3737 WEST 127TH ST.               SE DECISION MADE: 17-SEP-10
ALSIP IL 60803                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E-BASIC SINGLE BREAST PUMP
MAPA GMBH                         510(k) NO: K101157(TRADITIONAL)

ATTN: SHEILA W PICKERING          PHONE NO : 650 279 0668   
2081 LONGDEN CIRCLE               SE DECISION MADE: 17-SEP-10
LOS ALTOS CA 94024                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRASEAL ID
ULTRADENT PRODUCTS, INC.          510(k) NO: K101245(SPECIAL)

ATTN: DIANE  ROGERS               PHONE NO : 801 553 4491   
505 WEST 10200 SOUTH              SE DECISION MADE: 17-SEP-10
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)
CHROMOGENEX TECHNOLOGIES LTD      510(k) NO: K101366(TRADITIONAL)

ATTN: PETER R BEVAN               PHONE NO : 155 475 5444
UNITS 1&2 HEOL RHOSYN, PARC DAFEN SE DECISION MADE: 17-SEP-10
LLANELLI, CARMARTHENSHIRE    UK SA510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CO2 LASER SYSTEM
ADVANCED TECHNOLOGY LASER CO., LTD510(k) NO: K101555(TRADITIONAL)

ATTN: DIANA  HONG                 PHONE NO : 862 164 264467
LN 999, ZHONGSHAN #2 RD (S) SUITE SE DECISION MADE: 17-SEP-10
SHANGHAI    CH 200030             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SHAPE TO FIT COMPRESSION WEAR
TSUNG HAU TECHNOLOGY CO., LTD.    510(k) NO: K101906(TRADITIONAL)

ATTN: PEGGY  KUO                  PHONE NO : 
3F, BUILDING A, NO.248-21, SINSHENSE DECISION MADE: 17-SEP-10
TAIWAN, R.O.C.    TW 806 KH       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513
ANDON HEALTH CO.,LTD              510(k) NO: K102353(SPECIAL)

ATTN: LIU  YI                     PHONE NO : 862 260 526161
NO 3,  JINPING STREET YA AN RD NANSE DECISION MADE: 17-SEP-10
TIANJIN    CH 300190              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRYO-TOUCH II
MYOSCIENCE INC                    510(k) NO: K102021(SPECIAL)

ATTN: TRACEY  HENRY               PHONE NO : 650 474 2600   
525 CHESAPEAKE DRIVE              SE DECISION MADE: 17-SEP-10
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E-LIGHT LINE
ESPANSIONE MARKETING S.P.A        510(k) NO: K092734(TRADITIONAL)

ATTN: GUIDO  BONAPACE             PHONE NO : 39 335 5378686
VIA BORGO SANTA CRISTINA, 12      SE DECISION MADE: 20-SEP-10
IMOLA, BOLOGNA    IT 40026        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-
SEPPIM S.A.S.                     510(k) NO: K093883(TRADITIONAL)

ATTN: DEBRA K HUTSON              PHONE NO : 425 482 5174   
21720 23RD DR SE SUITE 150        SE DECISION MADE: 20-SEP-10
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GERATHERM UNIQUERESC
GERATHERM MEDICAL AG              510(k) NO: K093694(TRADITIONAL)
ATTN: ANDREA  PECSI               PHONE NO : 004 974 62924051
SCHWARZWALDSTRASSE 5              SE DECISION MADE: 20-SEP-10
TUTTLIGEN    GM 78532             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMM EQUIPMENT COVER-POLYTHYLENE
EXACT MEDICAL MANUFACTURING, INC  510(k) NO: K101689(TRADITIONAL)

ATTN: ROBERT O DEAN               PHONE NO : 716 440 7362   
1083 DELAWARE AVE                 SE DECISION MADE: 20-SEP-10
BUFFALO NY 14209                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHIMADZU COLLIMATOR R-300
SHIMADZU CORP.                    510(k) NO: K101039(ABBREVIATED)

ATTN: DON  KARLE                  PHONE NO : 310 217 8855   
20101 SOUTH VERMONT AVE.          SE DECISION MADE: 20-SEP-10
TORRANCE CA 90502 1328            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N
WMI ENTERPRISES LLC               510(k) NO: K100969(TRADITIONAL)

ATTN: MIKE  WILFORD               PHONE NO : 888 253 2555   
1017 W. WASHINGTON, 2J            SE DECISION MADE: 20-SEP-10
CHICAGO IL 60607                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
CINCINNATI SUB-ZERO PRODUCTS, INC.510(k) NO: K101589(TRADITIONAL)

ATTN: STEVEN J BERKE              PHONE NO : 513 772 8810   
12011 MOSTELLER RD.               SE DECISION MADE: 20-SEP-10
CINCINNATI OH 45241               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODEL SB100II FINGER PULSE OXIMETER
ATLANTEAN                         510(k) NO: K101568(TRADITIONAL)

ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 20-SEP-10
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RELINE-IT MODEL RELINE-IT
MAJESTIC DRUG CO., INC.           510(k) NO: K101771(TRADITIONAL)

ATTN: ROGER S MASTRONY            PHONE NO : 203 640 5047   
848-1/2 DERBY AVENUE              SE DECISION MADE: 20-SEP-10
ORANGE CT 06477                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K102017(TRADITIONAL)

ATTN: SHELLY  PEARCE              PHONE NO : 650 694 5988   
1230 SHOREBIRD WAY                SE DECISION MADE: 20-SEP-10
MOUNTAIN VIEW CA 94039 7393       510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004
EXACT MEDICAL MANUFACTURING, INC  510(k) NO: K101688(TRADITIONAL)

ATTN: ROBERT O DEAN               PHONE NO : 716 440 7362   
1083 DELAWARE AVE                 SE DECISION MADE: 20-SEP-10
BUFFALO NY 14209                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALBOSURE POLYESTER VASCULAR PATCH
LEMAITRE VASCULAR, INC.           510(k) NO: K101740(TRADITIONAL)

ATTN: VIC  ZHANG                  PHONE NO : 781 221 2266   
63 2ND AVENUE                     SE DECISION MADE: 20-SEP-10
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534
ANDON HEALTH CO.,LTD              510(k) NO: K102356(SPECIAL)

ATTN: LIU  YI                     PHONE NO : 862 260 526161
NO 3,  JINPING STREET YA AN RD NANSE DECISION MADE: 20-SEP-10
TIANJIN    CH 300190              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
ARTHROCARE CORP.                  510(k) NO: K100479(TRADITIONAL)

ATTN: VALERIE  DEFIESTA-NG        PHONE NO : 408 736 0224   
680 VAQUEROS AVE.                 SE DECISION MADE: 21-SEP-10
SUNNYVALE CA 94085 3523           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES
ZIMMER SPINE, INC                 510(k) NO: K100845(TRADITIONAL)

ATTN: DAVID  PADGETT, RAC (US)    PHONE NO : 512 918 2700   
5301 RIATA PARK COURT BUILDING F  SE DECISION MADE: 21-SEP-10
AUSTIN TX 78727                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELEGANT WHITE NITRILE EXAMINATION GLOVES POWDER FREE MODEL 1, ELEGANT BLUE NITRILE EXAMINATION GLOVES POWDER FREE MODEL,
PROFIT POINT MANUFACTURING SDN BHD510(k) NO: K101760(TRADITIONAL)
ATTN: ROBERT  HILL                PHONE NO : 607 787 9786
JALAN MERSING KAWASAN PERIDUSTRIA SE DECISION MADE: 21-SEP-10
KLUANG, JOHOR    MY 86000         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRITICAL CARE ASSESSMENT
CRITICAL PATIENT CARE, INC.       510(k) NO: K101983(TRADITIONAL)

ATTN: MARIE  COSGROVE             PHONE NO : 214 810 9062   
4005 BLACKHAWK STREET             SE DECISION MADE: 21-SEP-10
ENDINBURG TX 78539                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
STERIS CORPORATION                510(k) NO: K102462(SPECIAL)

ATTN: ROBERT  SULLIVAN            PHONE NO : 440 392 7695   
5960 HEISLEY RD.                  SE DECISION MADE: 21-SEP-10
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CALGAESEAL MODEL: CAS
BZ MEDICAL INC                    510(k) NO: K101097(TRADITIONAL)

ATTN: BYRON  ZAHLER               PHONE NO : 503 244 7348   
6611 SW BURLINGAME AVE            SE DECISION MADE: 22-SEP-10
PORTLAND OR 97239                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S
ASAHI INTECC CO., LTD.            510(k) NO: K100578(SPECIAL)

ATTN: YOSHI  TERAI                PHONE NO : 949 756 8252   
2500 RED HILL SUITE 210           SE DECISION MADE: 22-SEP-10
SANTA ANA, CA 92705               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UROSTATION 3D PROSTATE SUITE
KOELIS                            510(k) NO: K100793(TRADITIONAL)

ATTN: CECILE  DESMULIE            PHONE NO : 337 764 637588
5 AVENUE DU GRAND SABLON          SE DECISION MADE: 22-SEP-10
LA TRONCHE    FR 38700            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENSITE VERISMO SEGMENTATION TOOL V.2.0
ST. JUDE MEDICAL                  510(k) NO: K101697(TRADITIONAL)

ATTN: KRIS  MILLER                PHONE NO : 651 523 6985   
177 EAST COUNTY ROAD B            SE DECISION MADE: 22-SEP-10
ST. PAUL MN 55117                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ASCENT F-COAT MODEL: 006-00097
CAO GROUP, INC.                   510(k) NO: K100540(TRADITIONAL)

ATTN: ROBERT  LARSEN              PHONE NO : 801 256 9282   
4628 WEST SKYHAWK DRIVE           SE DECISION MADE: 23-SEP-10
WEST JORDAN UT 84084              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD
ADVANCED VERTEBRAL SOLUTIONS, LLC 510(k) NO: K100037(TRADITIONAL)

ATTN: MIKE  DUGERY                PHONE NO : 215 534 2481   
124 S. MAPLE STREET               SE DECISION MADE: 23-SEP-10
AMBLER PA 19002                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCUSCULPT II LASER SYSTEM
LUTRONIC CORPORATION              510(k) NO: K101573(TRADITIONAL)

ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207 1245   
5 TIMBER LANE                     SE DECISION MADE: 23-SEP-10
NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFIRM DO DIODE LASER
CYNOSURE, INC.                    510(k) NO: K101601(TRADITIONAL)

ATTN: ANTHONY  BURNS              PHONE NO : 978 256 4200   
5 CARLISLE ROAD                   SE DECISION MADE: 23-SEP-10
WESTFORD MA 01886                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GUIDE CATHETERS AND ACCESSORIES
THOMAS MEDICAL PRODUCTS, INC.     510(k) NO: K101015(TRADITIONAL)

ATTN: TIM  STOUDT                 PHONE NO : 610 651 5000   
65 GREAT VALLEY PKWY.             SE DECISION MADE: 23-SEP-10
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEOWIRE PTA/PTCA GUIDEWIRE
NEO METRICS, INC.                 510(k) NO: K101729(TRADITIONAL)

ATTN: GENE  CHAMPEAU              PHONE NO : 763 559 4440   
2605 FERNBROOK LANE NORTH SUITE J SE DECISION MADE: 23-SEP-10
PLYMOUTH MN 55447                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
SYNTHES USA PRODUCTS LLC          510(k) NO: K102018(TRADITIONAL)

ATTN: JEFFREY L DOW               PHONE NO : 484 356 9720   
1230 WILSON DRIVE                 SE DECISION MADE: 23-SEP-10
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROSA SURGICAL DEVICE
MEDTECH SAS                       510(k) NO: K101791(TRADITIONAL)

ATTN: BERTIN  NAHUM               PHONE NO : 334 671 07740
1006 RUE DE LA CROIX VERTE PARC EUSE DECISION MADE: 23-SEP-10
MONTPELLIER    FR 34090           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEURALMAS
INNOVATIVE SURGICAL SOLUTIONS, LLC510(k) NO: K100992(TRADITIONAL)

ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 949 706 7456   
55 NORTHERN BLVD SUITE 200        SE DECISION MADE: 24-SEP-10
GREAT NECK NY 10021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STALIF MIDLINE
CENTINEL SPINE                    510(k) NO: K101301(SPECIAL)

ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5800   
1331  H STREET NW 12TH FLOOR      SE DECISION MADE: 24-SEP-10
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOCORRO SMI TUNNEL RELEASE DEVICE
SOCORRO MEDICAL, INC.             510(k) NO: K102219(TRADITIONAL)

ATTN: ED  DIAO                    PHONE NO : 415 362 8880   
450 SUTTE STREET SUITE 500        SE DECISION MADE: 24-SEP-10
SAN FRANCISCO CA 94108            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GMK REVISION KNEE SYSTEM
MEDACTA INTERNATIONAL, SA         510(k) NO: K102437(SPECIAL)

ATTN: NATALIE J KENNEL            PHONE NO : 858 705 0350   
13721 VIA TRES VISTA              SE DECISION MADE: 24-SEP-10
SAN DIEGO CA 92129                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISOLED AC-POWERED LED HEADLIGHT SYSTEM
ISOLUX LLC                        510(k) NO: K102266(TRADITIONAL)

ATTN: NIKOLAUS  ANDREOULAKIS      PHONE NO : 239 514 7454   
1045 COLLIER CENTER WAY SUITE #6  SE DECISION MADE: 24-SEP-10
NAPLES FL 34110 8444              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PATIENT MONITOR
GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K102040(SPECIAL)

ATTN: ANA  HONG                   PHONE NO : 86 216 4264467
5D, NO. 19, LANE 999 ZHONGSHAN RD SE DECISION MADE: 24-SEP-10
SHANGHAI    CH 200030             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUICKVUE RSV 10
QUIDEL CORP.                      510(k) NO: K101918(TRADITIONAL)

ATTN: JENNIFER S HANKARD          PHONE NO : 858 552 7910   
10165 MCKELLAR CT.                SE DECISION MADE: 24-SEP-10
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FDI GLUCOSE CONTROL SOLUTIONS
FUJIREBIO DIAGNOSTICS, INC        510(k) NO: K102260(TRADITIONAL)

ATTN: KENT  PRUETT                PHONE NO : 830 372 1391   
940 CROSSROADS BLVD.              SE DECISION MADE: 24-SEP-10
SEGUIN TX 78155                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITOMATRIX
ORTHOVITA, INC.                   510(k) NO: K091618(TRADITIONAL)

ATTN: DEBORAH L JACKSON           PHONE NO : 610 407 5210   
45 GREAT VALLEY PKWY.             SE DECISION MADE: 27-SEP-10
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW CIRCULAR FIXATION SYSTEM
SMITH & NEPHEW, INC.              510(k) NO: K093047(TRADITIONAL)

ATTN: SHEREEN  MYERS              PHONE NO : 901 399 6325   
1450 EAST BROOKS RD.              SE DECISION MADE: 27-SEP-10
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERCU-PRO GUIDEWIRE
CARDIOSOLUTIONS INC               510(k) NO: K094062(TRADITIONAL)

ATTN: MICHELE  LUCEY              PHONE NO : 781 344 0801   
75 MILL STREET                    SE DECISION MADE: 27-SEP-10
STOUGHTON MA 02072                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATEK SURGICAL GOWNS
HANGZHOU ATEK MEDICAL & TEXTILE CO510(k) NO: K100971(TRADITIONAL)

ATTN: GLEN  FEYE                  PHONE NO : 619 517 1762   
1340 WEST PENNSYLVANIA AVENUE     SE DECISION MADE: 27-SEP-10
SAN DIEGO CA 92103                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIRECT CROWN NATURAL 1
CANDULOR USA, INC.                510(k) NO: K101814(TRADITIONAL)

ATTN: DONNA MARIE  HARTNETT       PHONE NO : 716 691 0010   
7462 N. FIGUEROA STREET SUITE 104 SE DECISION MADE: 27-SEP-10
LOS ANGELES CA 90041              510(k) STATEMENT

DEVICE: CONSTRUX MINI PEEK SPACER SYSTEM
ORTHOFIX INC.                     510(k) NO: K101812(TRADITIONAL)

ATTN: RUSSELL  JOHNSON            PHONE NO : 972 529 3177   
1720 BRAY CENTRAL DR.             SE DECISION MADE: 27-SEP-10
MCKINNEY TX 75069                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VESSEL GUARDIAN
LEXION MEDICAL, LLC.              510(k) NO: K102136(TRADITIONAL)

ATTN: BERNARD  HORWATH            PHONE NO : 651 635 0000   
5000 TOWNSHIP PKWY                SE DECISION MADE: 27-SEP-10
ST. PAUL MN 55110                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
TANGSHAN YONKSHUN GLOVE, CO., LTD 510(k) NO: K100421(TRADITIONAL)

ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
ROM 1606 BLDG 1 JIANXIANG YUAN NO.SE DECISION MADE: 27-SEP-10
ZHO, BEIJING    CH 100083         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES
HONG DI PLASTIC PRODUCTS CO, LTD. 510(k) NO: K102098(TRADITIONAL)

ATTN: JIE  LIU                    PHONE NO : 909 590 1611   
3973 SCHAEFER AVE.                SE DECISION MADE: 27-SEP-10
CHINO CA 91710                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK           510(k) NO: K091445(TRADITIONAL)

ATTN: LEE  GRANT                  PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 27-SEP-10
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINI MAXLOCK EXTREME PLATING SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K101962(TRADITIONAL)

ATTN: DEREK  LEWIS                PHONE NO : 330 869 9562   
1065 MEDINA ROAD SUITE 500        SE DECISION MADE: 27-SEP-10
MEDINA OH 44256                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712
ENCORE MEDICAL, L.P.              510(k) NO: K091956(TRADITIONAL)

ATTN: ELIZABETH  ONDERLINDE       PHONE NO : 512 834 6302   
9800 METRIC BLVD.                 SE DECISION MADE: 28-SEP-10
AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
KAMIYA BIOMEDICAL CO.             510(k) NO: K093137(TRADITIONAL)

ATTN: SHAWN  KAPLAN               PHONE NO : 206 575 8068   
12779 GATEWAY DR.                 SE DECISION MADE: 28-SEP-10
SEATTLE WA 98168                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)
SONOMA ORTHOPEDIC PRODUCTS, INC.  510(k) NO: K100112(TRADITIONAL)

ATTN: CARLOS  GONZALEZ            PHONE NO : 707 526 1335   
650 LARKFIELD CENTER SUITE C      SE DECISION MADE: 28-SEP-10
SANTA ROSA CA 95403               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
POLYMEDCO, INC.                   510(k) NO: K100550(TRADITIONAL)

ATTN: HELEN  LANDICHO             PHONE NO : 206 262 7363   
510 FURNACE DOCK RD.              SE DECISION MADE: 28-SEP-10
CORTLANDT MANOR NY 10567          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUXATEMP ULTRA /STAR
DMG USA, INC.                     510(k) NO: K101710(ABBREVIATED)

ATTN: PAMELA  PAPINEAU            PHONE NO : 978 772 3552   
5 WHITCOMB AVE.                   SE DECISION MADE: 28-SEP-10
AYER MA 01432                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH
GLAXOSMITHKLINE CONSUMER HEALTHCAR510(k) NO: K101477(TRADITIONAL)

ATTN: WENDY  MCMANUS              PHONE NO : 973 889 4415   
1500 LITTLETON ROAD               SE DECISION MADE: 28-SEP-10
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITEK 2 YEAST CASPOFUNGIN
BIOMERIEUX, INC.                  510(k) NO: K101566(TRADITIONAL)

ATTN: NANCY  WEAVER               PHONE NO : 314 731 8695   
595 ANGLUM RD.                    SE DECISION MADE: 28-SEP-10
HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APEX KNEE MODULAR  TIBIA SYSTEM
OMNLIFE SCIENCE                   510(k) NO: K101994(TRADITIONAL)

ATTN: RADHIKA  TAUNTON            PHONE NO : 774 226 1852   
50 O'CONNELL WAY                  SE DECISION MADE: 28-SEP-10
EAST TAUNTON MA 02718             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS
ALMA LASERS, INC.                 510(k) NO: K102716(SPECIAL)

ATTN: TATIANA  EPSTEIN            PHONE NO : 224 377 2011   
485 HALF DAY RD. SUITE #100       SE DECISION MADE: 28-SEP-10
BUFFALO GROVE IL 60089            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DOCTOR SURGERY DIODE LASERS FAMILY
LAMBDA S.P.A.                     510(k) NO: K102036(ABBREVIATED)

ATTN: BOSCHI  ALESSANDRO          PHONE NO : 390 444 349165
VIA DEL'IMPRESA 1                 SE DECISION MADE: 28-SEP-10
BRENDOLA, VICENZA    IT 36040     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FAT CONCENTRATION SYSTEM
BIOMET, INC.                      510(k) NO: K100114(TRADITIONAL)

ATTN: LONNIE  WITHAM              PHONE NO : 574 371 3095   
56 EAST BELL DR. P.O. BOX 587     SE DECISION MADE: 29-SEP-10
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRIT-LINE ANEMIA MANAGEMENT SOFTWARE
HEMA METRICS, LLC                 510(k) NO: K093834(TRADITIONAL)

ATTN: TERRY  LANIER               PHONE NO : 801 389 1947   
136 W. 2ND ST.                    SE DECISION MADE: 29-SEP-10
OGDEN UT 84404                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EBERLE SHAVER SYSTEM ACCESSORIES
EFS EBERLE FEINWERKTECHNISCHE SYST510(k) NO: K092977(TRADITIONAL)

ATTN: GERALD  GOIGITZER           PHONE NO : 954 217 8780   
731-733 SHOTGUN ROAD              SE DECISION MADE: 29-SEP-10
FT. LAUDERDALE FL 33326           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEPUY UNIVERSAL GRIPTION TF CONES
DEPUY ORTHOPAEDICS, INC.          510(k) NO: K100391(TRADITIONAL)

ATTN: DAWN  SINCLAIR, MA          PHONE NO : 574 372 5023   
700 ORTHOPAEDIC DR.               SE DECISION MADE: 29-SEP-10
WARSAW IN 46581 0988              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: C2000 POWERED WHEELCHAIR
OTTO BOCK HEALTH CARE, LP         510(k) NO: K101524(TRADITIONAL)

ATTN: WILLIAM  KABITZ             PHONE NO : 763 253 5610   
TWO CARLSON PARKWAY NORTH SUITE 10SE DECISION MADE: 29-SEP-10
MINNEAPOLIS MN 55447              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RELAY POWER WHEELCHAIR
DALTON INSTRUMENT CORP.           510(k) NO: K101611(TRADITIONAL)

ATTN: JENNIFER  YU                PHONE NO : 469 522 1200   
3788 ARAPAHO RD                   SE DECISION MADE: 29-SEP-10
ADDIISON TX 75001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM
LDR SPINE USA                     510(k) NO: K102265(SPECIAL)

ATTN: BECKINAM  NOWATZKE          PHONE NO : 512 344 3407   
4030 WEST BRAKER LANE SUITE 360   SE DECISION MADE: 29-SEP-10
AUSTIN TX 78759                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)
SILMET LTD.                       510(k) NO: K101869(TRADITIONAL)

ATTN: SHARON  CHAPLIK             PHONE NO : 972 353 31474
12 HASADNA                        SE DECISION MADE: 29-SEP-10
OR YEHUDA    IS 60200             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMSINO I.V. ADMINISTRATION AND EXTENSION SETS
AMSINO INTERNATIONAL, INC.        510(k) NO: K101958(SPECIAL)

ATTN: JESUS  FARINAS              PHONE NO : 909 626 5888   
855 TOWNE CENTER DR.              SE DECISION MADE: 29-SEP-10
POMONA CA 91767                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRYOBALLOON ABLATION SYSTEM
C2 THERAPEUTICS                   510(k) NO: K101825(TRADITIONAL)

ATTN: PETER  GARCIA-MEZA          PHONE NO : 650 521 5304   
303 CONVENTION WAY SUITE 1        SE DECISION MADE: 29-SEP-10
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EP NAVIGATOR R3
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K101311(TRADITIONAL)
ATTN: LYNN  HARMER                PHONE NO : 425 487 7312   
22100 BOTHELL EVERETT HWY. P.O. BOSE DECISION MADE: 30-SEP-10
BOTHELL WA 98041 3003             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE
GIVEN IMAGING LTD.                510(k) NO: K101200(TRADITIONAL)
ATTN: TIM  THOMAS                 PHONE NO : 972 490 97936
SHAAR YOKNEAM (HERMON BUILDING NEWSE DECISION MADE: 30-SEP-10
YOKNEAM      (P.O.BOX 258)    IS 2510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
SONOSCAPE COMPANY LIMITED         510(k) NO: K101337(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 164 264467
5D, #19 LANE 999, ZHONGSHAN ROAD 9SE DECISION MADE: 30-SEP-10
SHANGHAI    CH 20030              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TSRH(R) SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK           510(k) NO: K101772(TRADITIONAL)
ATTN: LILA  JOE                   PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 30-SEP-10
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM
SPINE SMITH PARTNERS L.P.         510(k) NO: K102090(SPECIAL)
ATTN: LAURA  LEBOEUF              PHONE NO : 512 637 2068   
93 RED RIVER                      SE DECISION MADE: 30-SEP-10
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0
PHILIPS MEDICAL SYSTEMS           510(k) NO: K102495(SPECIAL)
ATTN: THERESA  POOLE              PHONE NO : 978 659 7621   
3000 MINUTEMEN RD.                SE DECISION MADE: 30-SEP-10
ANDOVER MA 01810 1099             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K102156(SPECIAL)
ATTN: DEREK  LEWIS                PHONE NO : 330 869 9562   
1065 MEDINA ROAD SUITE 500        SE DECISION MADE: 30-SEP-10
MEDINA OH 44256                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: P200MAAF
OPTOS PLC                         510(k) NO: K102492(SPECIAL)
ATTN: HOWARD M HOLSTEIN           PHONE NO : 202 637 5815   
555 THIRTEENTH ST. N.W. COLUMBIA SSE DECISION MADE: 30-SEP-10
WASHINGTON DC 20004 1109          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CALYPSO SYSTEM WITH DYNAMIC EDGE GATING
CALYPSO MEDICAL TECHNOLOGIES INC  510(k) NO: K102373(SPECIAL)
ATTN: ED  VERTATSCHITSCH          PHONE NO : 206 774 4205   
2101 FOURTH AVE SUITE 500         SE DECISION MADE: 30-SEP-10
SEATTLE WA 98121                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRIMALOK FACET FIXATION SYSTEM
OSTEOMED L.P.                     510(k) NO: K102438(TRADITIONAL)
ATTN: KAREN E WARDEN              PHONE NO : 440 729 8457   
8202 SHERMAN ROAD                 SE DECISION MADE: 30-SEP-10
CHESTERLAND OH 44026              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZOLL PROPAQ MD
ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K102468(SPECIAL)
ATTN: PAUL  DIAS                  PHONE NO : 978 421 9413   
269 MILL ROAD                     SE DECISION MADE: 30-SEP-10
CHELMSFORD MA 01824 4105          510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   192                                     
                                                 TOTAL WITH SUMMARIES        188                                     
                                                 TOTAL WITH STATEMENTS        4
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