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U.S. Department of Health and Human Services

Medical Devices

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June 2011 510(k) Clearances

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


DEVICE: INVADER FACTOR V
HOLOGIC, INC.                     510(k) NO: K100980(TRADITIONAL)
ATTN: RANDALL J COVILL            PHONE NO : 508 263 8853   
250 CAMPUS DRIVE                  SE DECISION MADE: 01-JUN-11
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONNEX VITAL SIGNS MONITOR 6000 SERIES
WELCH ALLYN, INC.                 510(k) NO: K110516(SPECIAL)
ATTN: FRED  SCHWEITZER            PHONE NO : 315 554 4001   
4341 STATE ST. RD. P.O. BOX 220   SE DECISION MADE: 01-JUN-11
SKANEATELES FALLS NY 13153 0220   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JETSTREAM G3 (R) SF 1.6 SYSTEM
PATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K111229(SPECIAL)
ATTN: CYNDY  ADAMS                PHONE NO : 425 636 4047   
10801 120TH AVENUE NE             SE DECISION MADE: 01-JUN-11
KIRKLAND WA 98033                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIS ANTERIOR CERVICAL PLATING SYSTEM
LIFE SPINE                        510(k) NO: K103423(TRADITIONAL)
ATTN: RANDY  LEWIS                PHONE NO : 847 884 6117   
2401 W. HASSELL RD. SUITE 1535    SE DECISION MADE: 01-JUN-11
HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: H-WAVE
ELECTRONIC WAVEFORM LABORATORY, IN510(k) NO: K103738(SPECIAL)
ATTN: RYAN P HEANEY               PHONE NO : 800 874 9283   
16168 BEACH BLVD., SUITE 232      SE DECISION MADE: 01-JUN-11
HUNTINGTON BEACH CA 92647         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIT, PHACOFRAGMENTATION
ABBOTT MEDICAL OPTICS INC         510(k) NO: K103023(ABBREVIATED)
ATTN: EVELYN  DE LA VEGA          PHONE NO : 714 247 8487   
1700 E. ST. ANDREW PLACE          SE DECISION MADE: 01-JUN-11
SANTA ANA CA 92705                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
RESPIRONICS, INC.                 510(k) NO: K110398(ABBREVIATED)
ATTN: JOSEPH E OLSAVSKY           PHONE NO : 724 387 7562   
1740 GOLDEN MILE HIGHWAY          SE DECISION MADE: 01-JUN-11
MONROEVILLE PA 15146              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INVADER FACTOR II
HOLOGIC, INC.                     510(k) NO: K100943(TRADITIONAL)
ATTN: RANDALL  COVILL             PHONE NO : 508 263 8853   
250 CAMPUS DRIVE                  SE DECISION MADE: 02-JUN-11
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WATCH-PAT 200S-3 (WP200S-3)
ITAMAR MEDICAL LTD                510(k) NO: K102567(TRADITIONAL)
ATTN: JONATHAN  KAHN              PHONE NO : 202 637 5794   
555 THIRTEENTH STREET, NW         SE DECISION MADE: 02-JUN-11
WASHINGTON DC 20004 1109          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER
ABBOTT VASCULAR                   510(k) NO: K110617(TRADITIONAL)
ATTN: SUZANNE  REDMAN             PHONE NO : 951 914 3243   
26531 YNEZ ROAD                   SE DECISION MADE: 02-JUN-11
TEMECULA CA 92591                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALARA T210 COMPUTED RADIOGRAPHY SYSTEM
ALARA, INC.                       510(k) NO: K102479(TRADITIONAL)
ATTN: CHRISTOPHER  MITCHELL       PHONE NO : 510 315 5200   
47505 SEABRIDGE DRIVE             SE DECISION MADE: 02-JUN-11
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AOS ORION IR-192 SOURCE CABLE
ALPHA-OMEGA SERVICES, INC.        510(k) NO: K102811(TRADITIONAL)
ATTN: BOB A ROBNETT               PHONE NO : 562 804 0604   
9156 ROSE ST                      SE DECISION MADE: 02-JUN-11
BELLFLOWER CA 90706               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAMPAX C PLASTIC TAMPONS, UNSCENTED
THE PROCTER & GAMBLE CO.          510(k) NO: K110669(SPECIAL)
ATTN: KATHLEEN  BLIESZNER         PHONE NO : 513 634 3168   
6110 CENTER HILL AVE.             SE DECISION MADE: 02-JUN-11
CINCINNATI OH 45224               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HET BIPOLAR ELECTROCAUTERY FORCEPS
HET SYSTEMS, LLC                  510(k) NO: K110143(TRADITIONAL)
ATTN: HOWARD L SCHRAYER           PHONE NO : 609 924 9510   
1502 E 14TH STREET SUITE 2        SE DECISION MADE: 02-JUN-11
BROOKLYN NY 11230                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APTUS CANNULATED COMPRESSION SCREWS
MEDARTIS AG                       510(k) NO: K110658(TRADITIONAL)
ATTN: KEVIN A THOMAS              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL, SUITE 200   SE DECISION MADE: 02-JUN-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST
RESPIRONICS NOVAMETRIX, LLC       510(k) NO: K103578(TRADITIONAL)
ATTN: KEVIN  MADER                PHONE NO : 203 697 6466   
5 TECHNOLOGY DRIVE                SE DECISION MADE: 02-JUN-11
WALLINGFORD CT 06492              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MYLABGOLD
ESAOTE                            510(k) NO: K110688(TRADITIONAL)
ATTN: ALLISON  SCOTT              PHONE NO : 317 569 9500   
11460 N. MERIDIAN ST., STE. 150   SE DECISION MADE: 02-JUN-11
CARMEL IN 46032                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: BRIDGEPOINT  SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM
ALPHATEC SPINE, INC.              510(k) NO: K103205(TRADITIONAL)
ATTN: OLGA  LEWIS                 PHONE NO : 760 494 6717   
2051 PALOMAR AIRPORT ROAD SUITE 10SE DECISION MADE: 02-JUN-11
CARLSBAD CA 92011                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K103548(ABBREVIATED)
ATTN: SANDRA D WHITE              PHONE NO : 508 660 4553   
333 CONEY  STREET                 SE DECISION MADE: 02-JUN-11
EAST WALPOLE MA 02032             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F
BOSTON SCIENTIFIC CORP.           510(k) NO: K111252(SPECIAL)
ATTN: HOLLY  RAMIREZ              PHONE NO : 763 494 2113   
ONE SCIMED PLACE                  SE DECISION MADE: 02-JUN-11
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMNI II PATIENT MONITOR
INFINIUM MEDICAL                  510(k) NO: K103737(SPECIAL)
ATTN: JOHN  OBRIEN                PHONE NO : 813 645 2855   
962 ALLEGRO LN.                   SE DECISION MADE: 02-JUN-11
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REGUIS SIGMA
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K103703(TRADITIONAL)
ATTN: RUSSELL  MUNVES             PHONE NO : 212 497 8208   
140 EAST 45TH ST., 25TH FLOOR TWO SE DECISION MADE: 02-JUN-11
NEW YORK NY 10017                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IGX PLEX CELIAC QUALITATIVE ASSAY
SQI DIAGNOSTICS SYSTEMS           510(k) NO: K102490(TRADITIONAL)
ATTN: KATE  SMITH                 PHONE NO : 416 674 9500
36 METEOR DR.                     SE DECISION MADE: 02-JUN-11
TORONTO, ONTARIO    CA M9W 1A4    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TORNIER INSITE FT SUTURE ANCHOR
TORNIER, INC.                     510(k) NO: K110773(TRADITIONAL)
ATTN: BRAHIM  HADRI               PHONE NO : 978 232 9997   
100 CUMMINGS CENTER, SUITE 444C   SE DECISION MADE: 02-JUN-11
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRACTORA
INVASIX LTD.                      510(k) NO: K102461(TRADITIONAL)
ATTN: AMIR  WALDMAN               PHONE NO : 972 547 404616
APOLO BUILDING POB 533            SE DECISION MADE: 02-JUN-11
YOKNEAM ILLIT    IS 20692         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)...
COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K111442(SPECIAL)
ATTN: ROBERT  ZOTT                PHONE NO : 203 492 6013   
60 Middletown Ave                 SE DECISION MADE: 03-JUN-11
North Haven CT 06473              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISCOVERY NM 630
GE HEALTHCARE                     510(k) NO: K111445(TRADITIONAL)
ATTN: TAL  BRESLER-STRAMER        PHONE NO : 972 485 63666
4 HAYOZMA STREET                  SE DECISION MADE: 03-JUN-11
TIRAT HACARMEL    IS 30200        510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CARDIO XP
BIONET CO., LTD.                  510(k) NO: K102767(TRADITIONAL)
ATTN: MARC  GOODMAN               PHONE NO : 714 258 4646   
5405 ALTON PARKWAY, SUITE A530    SE DECISION MADE: 03-JUN-11
IRVINE CA 92604                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IPLAN
BRAINLAB AG                       510(k) NO: K101627(TRADITIONAL)
ATTN: ALEXANDER  SCHWIERSCH       PHONE NO : 49 89 9915680
KAPELLENSTRASSE 12                SE DECISION MADE: 03-JUN-11
FELDKIRCHEN    GM 85622           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OWL CANNULAE
DIROS TECHNOLOGY, INC.            510(k) NO: K102566(TRADITIONAL)
ATTN: GEORGE  DARMOS              PHONE NO : 905 415 3440
232 HOOD ROAD                     SE DECISION MADE: 03-JUN-11
MARKHAM, ONTARIO    CA L3R 3K8    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUGLUE-10
3M ESPE AG                        510(k) NO: K110508(TRADITIONAL)
ATTN: DESI W SOEGIARTO            PHONE NO : 498 152 7001169
ESPE PLATZ                        SE DECISION MADE: 03-JUN-11
SEEFELD, BAVARIA    GM D-82229    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40
BIO-MEDICAL RESEARCH, LTD.        510(k) NO: K102614(TRADITIONAL)
ATTN: ANNE-MARIE  KEENAN          PHONE NO : 353 917 74316
BMR HOUSE PARKMORE BUSINESS PARK, SE DECISION MADE: 03-JUN-11
GALWAY    EI EI                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
SONOSITE,INC.                     510(k) NO: K110645(TRADITIONAL)
ATTN: JESSICA R STENBERG          PHONE NO : 425 951 1432   
21919 30TH DRIVE SE.              SE DECISION MADE: 03-JUN-11
BOTHELL WA 98021 3904             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EMULSION SB
PRUGEN IP HOLDINGS, INC           510(k) NO: K110732(TRADITIONAL)
ATTN: ROBERT L KNECHTEL           PHONE NO : 480 585 0122   
8711 E PINNACLE PEAK ROAD SUITE C-SE DECISION MADE: 03-JUN-11
SCOTTSDALE AZ 85255               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMSCO WARMING CABINET
STERIS CORPORATION                510(k) NO: K110769(SPECIAL)
ATTN: ROBERT F SULLIVAN           PHONE NO : 440 392 7695   
5960 HEISLEY                      SE DECISION MADE: 03-JUN-11
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BILLY BOY MALE LATEX CONDOM
MAPA GMBH                         510(k) NO: K111093(TRADITIONAL)
ATTN: GERMAN  FRANK               PHONE NO : 494 281 730213
INDUSTRIESTRASSE 21-25            SE DECISION MADE: 03-JUN-11
ZEVEN    GM 27404                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ACE STAPLER AND CARTRIDGE
BAROSENSE, INC                    510(k) NO: K110829(SPECIAL)
ATTN: SHEILA  STEVENS, PHD        PHONE NO : 650 362 6000   
250 CHESAPEAKE DRIVE              SE DECISION MADE: 03-JUN-11
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISTAND
OPTOVUE, INC.                     510(k) NO: K103266(TRADITIONAL)
ATTN: JOHN J TALARICO             PHONE NO : 510 623 8868   
45531 NORTHPORT LOOP W.           SE DECISION MADE: 03-JUN-11
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUMINOS AGILE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K111292(SPECIAL)
ATTN: PATRICIA D JONES            PHONE NO : 610 484 3536   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 03-JUN-11
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHO EASY PIN
FORESTADENT BERNHARD FORSTER GMBH 510(k) NO: K110275(TRADITIONAL)
ATTN: TANYA  O'BRIEN              PHONE NO : 813 645 2855   
962 ALLEGRO LANE                  SE DECISION MADE: 03-JUN-11
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS
ADVANCED STERILIZATION PRODUCTS   510(k) NO: K103210(TRADITIONAL)
ATTN: NANCY  CHU                  PHONE NO : 949 453 6435   
33 TECHNOLOGY DR.                 SE DECISION MADE: 06-JUN-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
PPP MEDICAL AND SAFETY PRODUCTS CO510(k) NO: K110972(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
ROOM 1606 BUILDING 1 JIAN XIAN YUASE DECISION MADE: 06-JUN-11
RD. HAI DI,  BEIJING    CH 100083 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARTEMP
ULTRADENT PRODUCTS, INC.          510(k) NO: K111017(TRADITIONAL)
ATTN: DIANE  ROGERS               PHONE NO : 801 553 4491   
505 WEST 10200 SOUTH              SE DECISION MADE: 06-JUN-11
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEHIND EAR GENTLE TOUCH THERMOMETER
KAZ, INC.                         510(k) NO: K103839(ABBREVIATED)
ATTN: RAJ S KASBEKAR              PHONE NO : 508 490 7280   
250 TURNPIKE ROD                  SE DECISION MADE: 06-JUN-11
SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE
TERUMO EUROPE N.V.                510(k) NO: K110527(TRADITIONAL)
ATTN: M. J AERTS                  PHONE NO : 32 016 381211
INTERLEUVENLAAN 40                SE DECISION MADE: 06-JUN-11
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM
DENTSPLY INTERNATIONAL, INC.      510(k) NO: K110753(TRADITIONAL)
ATTN: HELEN  LEWIS                PHONE NO : 717 849 4229   
221 WEST PHILADELPHIA ST. SUITE 60SE DECISION MADE: 06-JUN-11
YORK PA 17404                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLUE POWDERFREE NITRILE EXAMINATION GLOVE
PT. MEDISAFE TECHNOLOGIES         510(k) NO: K102623(TRADITIONAL)
ATTN: ANIL  TANEJA                PHONE NO : 626 130 007134
JL.BATANG KUIS GG.TAMBAK REJO DESASE DECISION MADE: 06-JUN-11
MEDAN, NORTH SUMATERA    ID 20362 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
SAC, LLC DBA PINNACLE MEDICAL SURG510(k) NO: K101733(TRADITIONAL)
ATTN: DAVE  STRAIN                PHONE NO : 407 745 1027   
P.O. BOX 782108                   SE DECISION MADE: 06-JUN-11
ORLANDO FL 32878 2108             510(k) STATEMENT

DEVICE: MINI VARIABLE SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K111041(SPECIAL)
ATTN: DEREK  LEWIS                PHONE NO : 330 869 9562   
1065 MEDINA ROAD SUITE 500        SE DECISION MADE: 06-JUN-11
MEDINA OH 44256                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRUBLUE NASAL MASK
RESPIRONICS, INC.                 510(k) NO: K110405(SPECIAL)
ATTN: MICHELLE  BRINKER           PHONE NO : 724 387 4146   
1001 MURRY RIDGE LN.              SE DECISION MADE: 06-JUN-11
MURRYSVILLE PA 15668              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC
DYNAREX CORPORATION               510(k) NO: K103086(TRADITIONAL)
ATTN: DANIEL  CONSAGA             PHONE NO : 845 365 8200   
10 GLENSHAW ST.                   SE DECISION MADE: 07-JUN-11
ORANGEBURG NY 10962               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ILLUMINATING SINUS SEEKER
ENTELLUS MEDICAL, INC.            510(k) NO: K110158(TRADITIONAL)
ATTN: KAREN E PETERSON            PHONE NO : 763 463 7056   
6705 WEDGWOOD COURT NORTH         SE DECISION MADE: 07-JUN-11
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG
CARDINAL HEALTH, INC.             510(k) NO: K110272(TRADITIONAL)
ATTN: TATYANA  BOGDAN             PHONE NO : 847 887 2325   
1430  WAUKEGAN ROAD               SE DECISION MADE: 08-JUN-11
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA
BUSSE HOSPITAL DISPOSABLES        510(k) NO: K110883(TRADITIONAL)
ATTN: MUHAMAD  ANSARI             PHONE NO : 631 435 4711   
75 ARKAY DRIVE                    SE DECISION MADE: 08-JUN-11
HAUPPAUGE NY 11788                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE
MIDWEST REPROCESSING CENTER LLC   510(k) NO: K111007(TRADITIONAL)
ATTN: SCOTT  SENNER               PHONE NO : 205 314 3920   
434 INDUSTRIAL LANE               SE DECISION MADE: 08-JUN-11
BIRMINGHAM AL 35211               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030)
EIZO GMBH                         510(k) NO: K103724(ABBREVIATED)
ATTN: GUENTER M VOLZ              PHONE NO : 49 721 20321282
SIEMENSALLEE 84                   SE DECISION MADE: 08-JUN-11
KARLSRUHE    GM 76187             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PACEART OPTIMA SYSTEM SOFTWARE
MEDTRONIC, INC.                   510(k) NO: K110693(TRADITIONAL)
ATTN: RACHEL U LIBI               PHONE NO : 763 526 1668   
8200 CORAL SEA STREET             SE DECISION MADE: 08-JUN-11
MOUNDS VIEW MN 55304              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO
ETHICON ENDO-SURGERY, LLC         510(k) NO: K111111(TRADITIONAL)
ATTN: LINDA  HILL                 PHONE NO : 513 337 7623   
4545 CREEK ROAD                   SE DECISION MADE: 08-JUN-11
CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMESH TACKER
EASYLAP LTD.                      510(k) NO: K110728(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 08-JUN-11
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
MEDYSSEY CO., LTD.                510(k) NO: K110284(SPECIAL)
ATTN: PATRICK  MOORE              PHONE NO : 801 266 4811   
6170 SOUTH 380 WEST SUITE 200     SE DECISION MADE: 08-JUN-11
MURRAY UT 84107                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTIPURPOSE DRAINAGE CATHETER
NAVILYST MEDICAL, INC.            510(k) NO: K111315(SPECIAL)
ATTN: WANDA  CARPINELLA           PHONE NO : 508 658 7929   
26 FOREST STREET                  SE DECISION MADE: 08-JUN-11
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANCK USA, INC. 510(k) NO: K110070(TRADITIONAL)
ATTN: LILA  JOE                   PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 08-JUN-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT
EXACTECH, INC.                    510(k) NO: K111379(SPECIAL)
ATTN: GRAHAM L CUTHBERT           PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 08-JUN-11
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
MEDTRONIC INC.                    510(k) NO: K111339(SPECIAL)
ATTN: AMRA  RACIC                 PHONE NO : 763 514 9838   
8200 CORAL SEA STREET NE          SE DECISION MADE: 08-JUN-11
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ERKA. PERFECT-ANEROID
ERKA KALLMEYER MEDIZINTECHNIK GMBH510(k) NO: K103637(TRADITIONAL)
ATTN: JAN  WEISS                  PHONE NO : 498 041 80090
IM FARCHET 15                     SE DECISION MADE: 08-JUN-11
BAD TOELZ, BAVARIA    GM 83646    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: BIOGRAPH MMR
SIEMENS MEDICAL SOLUTIONS USA INC.510(k) NO: K103429(TRADITIONAL)
ATTN: ALAINE  MEDIO               PHONE NO : 865 218 2703   
810 INNOVATION DRIVE              SE DECISION MADE: 08-JUN-11
KNOXVILLE TN 37932                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AEROVENT PLUS CHC
MONAGHAN MEDICAL CORPORATION      510(k) NO: K110273(TRADITIONAL)
ATTN: CARI J REIL                 PHONE NO : 518 561 7330   
5 LATOUR AVENUE, SUITE 1600       SE DECISION MADE: 09-JUN-11
PLATTSBURGH NY 12901              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K-PACK II NEEDLE- 27G & 30G THIN WALL
TERUMO EUROPE N.V.                510(k) NO: K110850(SPECIAL)
ATTN: M.J.  AERTS                 PHONE NO : 320 163 81211
INTERLEUVENLAAN 40                SE DECISION MADE: 09-JUN-11
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
VITAL DIAGNOSTICS (MANUFACTURING) 510(k) NO: K110394(ABBREVIATED)
ATTN: MELITA  LAMBIRIS            PHONE NO : 613 879 36300
189-199 BROWNS RD                 SE DECISION MADE: 09-JUN-11
NOBLE PARK, VICTORIA    AS 3174   510(k) STATEMENT

DEVICE: SAFEPORT MANIFOLD (TM) (OR STOPCOCK)
ELCAM MEDICAL A.C.A.L.            510(k) NO: K111016(SPECIAL)
ATTN: NATASHA  EVRONYAN           PHONE NO : 972 469 88821
KIBBUTZ BAR-AM                    SE DECISION MADE: 09-JUN-11
D.N. MEROM HAGALIL    IS 13860    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENGAGE/ENGAGE TR INTRODUCERS
ST. JUDE MEDICAL                  510(k) NO: K111092(SPECIAL)
ATTN: VENKATA  DAMARAJU           PHONE NO : 651 756 3259   
14901 DEVEAU PL.                  SE DECISION MADE: 09-JUN-11
MINNETONKA MN 55345 2126          510(k) STATEMENT

DEVICE: ATRICURE DISSECTOR
ATRICURE, INC.                    510(k) NO: K111020(SPECIAL)
ATTN: JAMES L LUCKY               PHONE NO : 513 755 4100   
6217 CENTRE PARK DRIVE            SE DECISION MADE: 09-JUN-11
WEST CHESTER OH 45069             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KJ MASK
KJ MEDITECH CO., LTD              510(k) NO: K103019(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 869 3080   
951 STARBUCK ST. UNIT J           SE DECISION MADE: 09-JUN-11
FULLERTON CA 92833                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS  SHBG CALCHECK 5
ROCHE DIAGNOSTICS                 510(k) NO: K111349(TRADITIONAL)
ATTN: KELLY  FRENCH               PHONE NO : 317 521 3208   
9115 HAGUE ROAD PO BOX 50416      SE DECISION MADE: 09-JUN-11
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS
CARDIAC SCIENCE CORPORATION       510(k) NO: K102496(SPECIAL)
ATTN: KATHLEEN  ROBERTS           PHONE NO : 949 797 3844   
3303 MONTE VILLA PKWY.            SE DECISION MADE: 09-JUN-11
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE
DMC MEDICAL LTD.                  510(k) NO: K103736(TRADITIONAL)
ATTN: TRACY  BEST                 PHONE NO : 801 498 0067   
944 NORTH MAIN STREET             SE DECISION MADE: 10-JUN-11
BOUNTIFUL UT 84010                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDIT MICROCV IMMUNOASSAY LINEARITY SET
AALTO SCIENTIFIC LTD.             510(k) NO: K103601(TRADITIONAL)
ATTN: DESSI  LYAKOV               PHONE NO : 760 431 7922   
1959 KELLOGG AVE.                 SE DECISION MADE: 10-JUN-11
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRESSURE MANOMETER
NEOFORCE GROUP INC                510(k) NO: K110119(TRADITIONAL)
ATTN: MONICA  FERRANTE            PHONE NO : 215 672 6800   
35 COMMERCE DRIVE                 SE DECISION MADE: 10-JUN-11
IVYLAND PA 18974                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER
CREGANNA-TACTX MEDICAL            510(k) NO: K110133(TRADITIONAL)
ATTN: DENNIS  WONG                PHONE NO : 408 364 7106   
1353 DELL AVENUE                  SE DECISION MADE: 10-JUN-11
CAMPBELL CA 95008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03
VEGA TECHNOLOGIES, INC.           510(k) NO: K102625(TRADITIONAL)
ATTN: JOSEPH  LU                  PHONE NO : 886 225 416996
11F-13, 100 CHANG-CHUN RD.        SE DECISION MADE: 10-JUN-11
TAIPEI    TW 104                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEFENDO Y-OPSY IRRIGATOR
BYRNE MEDICAL INCORPORATED        510(k) NO: K110088(TRADITIONAL)
ATTN: JOHN  WILLIS                PHONE NO : 936 521 4240   
3150 Pollok Drive                 SE DECISION MADE: 10-JUN-11
Conroe TX 77303                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CUSA NXT EXTENDED LENGTH TIP
INTEGRA RADIONICS, INC.           510(k) NO: K102258(TRADITIONAL)
ATTN: KEVIN J O'CONNELL           PHONE NO : 781 565 1227   
22 TERRY AVENUE                   SE DECISION MADE: 10-JUN-11
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA  COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS
SHENZHEN ENVISEN INDUSTRY CO. LIMI510(k) NO: K103584(TRADITIONAL)
ATTN: STEPHEN H GORSKI            PHONE NO : 262 594 2114   
S65 W35739 PIPER ROAD             SE DECISION MADE: 10-JUN-11
EAGLE WI 53119                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT
ASTRA TECH, INC.                  510(k) NO: K110640(TRADITIONAL)
ATTN: BETSY A BROWN               PHONE NO : 847 560 4406   
8944 TAMAROA TERR.                SE DECISION MADE: 10-JUN-11
SKOKIE IL 60076                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
JIANGSU DONGLING PLASTIC & RUBBER 510(k) NO: K110247(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
ROOM 1606 BUILDING 1,JIAN XIAN YUASE DECISION MADE: 10-JUN-11
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR
JIANGSU DONGLING PLASTIC & RUBBER 510(k) NO: K110248(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
ROOM 1606 BUILDING 1,JIAN XIAN YUASE DECISION MADE: 10-JUN-11
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTODELFIA NEONATAL IRT KIT
WALLAC OY, A SUBSIDIARY OF PERKINE510(k) NO: K110274(TRADITIONAL)
ATTN: SUSAN K HAMANN              PHONE NO : 781 663 5872   
940 WINTER STREET                 SE DECISION MADE: 10-JUN-11
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABBOTT ARCHITECT LH CALIBRATORS
ABBOTT LABORATORIES               510(k) NO: K111023(TRADITIONAL)
ATTN: JOHN  RIZOS                 PHONE NO : 847 935 1813   
100 ABBOTT PARK ROAD DEPT 9V6, AP5SE DECISION MADE: 10-JUN-11
ABBOTT PARK IL 60064              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAVIGATOR APPLICATIONS SUITE
GE HEALTHCARE FINLAND OY          510(k) NO: K102389(SPECIAL)
ATTN: MONICA  MORRISON            PHONE NO : 608 221 1551   
PO BOX 7550                       SE DECISION MADE: 10-JUN-11
MADISON WI 53707 7550             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
ANGIODYNAMICS, INC.               510(k) NO: K110936(TRADITIONAL)
ATTN: DAVID A GREER               PHONE NO : 518 795 1676   
14 PLAZA DRIVE                    SE DECISION MADE: 10-JUN-11
LATHAM NY 12110                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TEMPOCEM
DMG USA, INC.                     510(k) NO: K110759(ABBREVIATED)
ATTN: PAMELA  PAPINEAU            PHONE NO : 978 772 3552   
5 WHITCOMB AVE.                   SE DECISION MADE: 10-JUN-11
AYER MA 01432                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
PPP MEDICAL AND SAFETY PRODUCTS CO510(k) NO: K110969(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 86 10 82387441
ROOM 1606 BUILDING 1 JIAN XIAN YUASE DECISION MADE: 10-JUN-11
RD. HAI DI BEIJING    CH 100083   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)
MEDSHAPE SOLUTIONS, INC           510(k) NO: K111471(SPECIAL)
ATTN: JACK C GRIFFIS, III         PHONE NO : 404 249 9155   
1575 NORTHSIDE DRIVE NW SUITE 440 SE DECISION MADE: 10-JUN-11
ATLANTA GA 30318                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT
ASTRA TECH, INC.                  510(k) NO: K110356(TRADITIONAL)
ATTN: BETSY A BROWN               PHONE NO : 547 560 4406   
8944 TAMAROA TERR.                SE DECISION MADE: 10-JUN-11
SKOKIE IL 60076                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)
INFIMED, INC.                     510(k) NO: K111344(SPECIAL)
ATTN: CATHERINE  MULCAHY          PHONE NO : 315 453 4545   
121 METROPOLITAN DR.              SE DECISION MADE: 10-JUN-11
LIVERPOOL NY 13088                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAX PULSE SYSTEM
MEDICORE CO., LTD.                510(k) NO: K110374(TRADITIONAL)
ATTN: YOO  BYUNG-KUK              PHONE NO : 822 205 62650
3F, SAMWOO B/D, 339-2, JAMSIL DONGSE DECISION MADE: 13-JUN-11
SEOUL    KS                       510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11
ETHICON ENDO-SUGERY, LLC          510(k) NO: K101990(TRADITIONAL)
ATTN: DONOVAN  MAY                PHONE NO : 513 337 7981   
4545 CREEK RD.                    SE DECISION MADE: 13-JUN-11
CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MECTALIF
MEDACTA INTERNATIONAL             510(k) NO: K110927(TRADITIONAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 437 7085   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 13-JUN-11
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
SPINEOLOGY, INC.                  510(k) NO: K110933(TRADITIONAL)
ATTN: BRYAN  BECKER               PHONE NO : 651 256 8534   
7800 3RD ST N., SUITE 600         SE DECISION MADE: 13-JUN-11
ST. PAUL MN 55128                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
SOLCO BIOMEDICAL CO., LTD.        510(k) NO: K102458(SPECIAL)
ATTN: SAEYOUNG  AHN               PHONE NO : 301 602 4014   
9700 GREAT SENECA HWY SUITE 302   SE DECISION MADE: 13-JUN-11
ROCKVILLE MD 20850                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
TZ MEDICAL, INC.                  510(k) NO: K102507(ABBREVIATED)
ATTN: JOHN  LUBISICH              PHONE NO : 503 639 0282   
7272 SW DURHAM RD., #800          SE DECISION MADE: 13-JUN-11
PORTLAND OR 97224                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPACELABS PATHFINDER SL HOLTER ANALYZER
SPACELABS HEALTHCARE LTD.         510(k) NO: K110001(TRADITIONAL)
ATTN: THOMAS  KROENKE             PHONE NO : 303 956 4232   
PO BOX 3018                       SE DECISION MADE: 14-JUN-11
NEDERLAND CO 80466                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYDROFIX SURGICAL SHEET
MIMEDX GROUP, INC                 510(k) NO: K100313(TRADITIONAL)
ATTN: SALLY  THORSEN              PHONE NO : 678 384 6720   
811 LIVINGSTON COURT SE SUITE B   SE DECISION MADE: 14-JUN-11
MARIETTA GA 30067                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TEMPFLEX
KERR CORPORATION                  510(k) NO: K110747(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602   
1717 WEST COLLINS AVENUE          SE DECISION MADE: 14-JUN-11
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
TORNIER, INC.                     510(k) NO: K110599(TRADITIONAL)
ATTN: BRAHIM  HADRI               PHONE NO : 978 232 9997   
7701 FRANCE AVE SOUTH SUITE 600   SE DECISION MADE: 14-JUN-11
EDINA MN 55435                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADDITIVE CAP
BAXTER HEALTHCARE CORP.           510(k) NO: K111217(TRADITIONAL)
ATTN: NANETTE  HEDDEN             PHONE NO : 847 270 4871   
1620 WAULKEGAN RD.                SE DECISION MADE: 14-JUN-11
MCGAW PARK IL 60085 6730          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
COOK, INC.                        510(k) NO: K111244(SPECIAL)
ATTN: MIRONDA  CARPENTER          PHONE NO : 812 339 2235   
750 DANIELS WAY P.O. BOX 489      SE DECISION MADE: 14-JUN-11
BLOOMINGTON IN 47402              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENTELLUS MEDICAL SINUS GUIDEWIRE
ENTELLUS MEDICAL, INC.            510(k) NO: K110739(TRADITIONAL)
ATTN: KAREN E PETERSON            PHONE NO : 763 463 7056   
6705 WEDGWOOD COURT NORTH         SE DECISION MADE: 14-JUN-11
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EV1000 CLINICAL PLATFORM
EDWARDS LIFESCIENCES              510(k) NO: K110597(TRADITIONAL)
ATTN: MARGUERITE  THOMLINSON      PHONE NO : 949 756 4386   
ONE EDWARDS WAY                   SE DECISION MADE: 14-JUN-11
IRVINE CA 92614                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AEU-26L ELCTRONIC ENDODONTIC SYSTEM
ASEPTICO, INC.                    510(k) NO: K111078(ABBREVIATED)
ATTN: GRANT  RAMALEY              PHONE NO : 425 487 3157   
8333 216TH ST., S.E.              SE DECISION MADE: 14-JUN-11
WOODINVILLE WA 98072              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES
COMFORT RUBBER GLOVES INDUSTRIES S510(k) NO: K110297(TRADITIONAL)
ATTN: TAN  KENG BENG              PHONE NO : 605 847 2777
LOT 821, JALAN MATANG             SE DECISION MADE: 15-JUN-11
TAIPING, PERAK    MY 34750        510(k) STATEMENT

DEVICE: PONTO PRO POWER
OTICON MEDICAL AB                 510(k) NO: K103594(TRADITIONAL)
ATTN: ULRIKA  NIELSEN             PHONE NO : 463 174 86100
EKONOMIV 2                        SE DECISION MADE: 15-JUN-11
GOTHENBURG, ASKIM    SW SE-436 33 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOSPINE VBR SYSTEM
AESCULAP IMPLANT SYSTEMS, LLC     510(k) NO: K110864(TRADITIONAL)
ATTN: LISA  BOYLE                 PHONE NO : 610 984 9274   
3773 CORPORATE PARKWAY            SE DECISION MADE: 15-JUN-11
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISENSIA, VISENSIA WITH ALERT
OBS MEDICAL                       510(k) NO: K110953(SPECIAL)
ATTN: CHRIS  WEATHERALL           PHONE NO : 013 677 10208
ROSEMARY HOUSE 31 CHURCH GREEN STASE DECISION MADE: 15-JUN-11
IN THE VALE  OXFORD    UK SN7 8HU 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MD301C4 29.8" DIAGNOSTIC IMAGING LCD MONITOR, L309TY
NEC DISPLAY SOLUTIONS, LTD.       510(k) NO: K111237(TRADITIONAL)
ATTN: ANGUS  HSU                  PHONE NO : 886 226 037288
1F, NO. 181, SEC. 2 WUNHUA 1ST ROASE DECISION MADE: 15-JUN-11
NEW TAIPEI CITY    TW 2447        510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS
NOBEL BIOCARE USA LLC             510(k) NO: K110171(SPECIAL)
ATTN: HERBERT  CRANE              PHONE NO : 714 282 4800   
22715 SAVI RANCH PARKWAY          SE DECISION MADE: 15-JUN-11
YORBA LINDA CA 92887              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AZUR DETACHABLE 35 PLATINUM COIL SYSTEM
MICROVENTION, INC.                510(k) NO: K111307(TRADITIONAL)
ATTN: LARAINE  PANGELINA          PHONE NO : 714 247 8150   
1311 VALENCIA AVE                 SE DECISION MADE: 15-JUN-11
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLONOSCOPY ASSISTANT
STI MEDICAL SYSTEMS, LLC          510(k) NO: K102949(TRADITIONAL)
ATTN: ROLF  WOLTERS               PHONE NO : 808 540 4728   
99-193 AIEA HEIGHTS DRIVE         SE DECISION MADE: 15-JUN-11
AIEA HI 96701                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT
ARVIK ENTERPRISES/ MINI LAP TECHNO510(k) NO: K102274(TRADITIONAL)
ATTN: CURTIS  RAYMOND             PHONE NO : 203 922 0105   
80 SHELTON TECHNOLOGY CENTER      SE DECISION MADE: 15-JUN-11
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301
AG DIGITAL TECHNOLOGY CORP.       510(k) NO: K101641(TRADITIONAL)
ATTN: JENNIFER  REICH             PHONE NO : 928 863 8140   
2904 N. BOLDT DRIVE               SE DECISION MADE: 16-JUN-11
FLAGSTAFF AZ 86001                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GUARDACARE
HEMCON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K103641(TRADITIONAL)
ATTN: KEVIN  HAWKINS              PHONE NO : 503 245 0459   
10575 SW CASCADE AVENUE SUITE 130 SE DECISION MADE: 16-JUN-11
PORTLAND OR 97223 4363            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENCOR ENSPIRE BREAST BIOPSY SYSTEM
C.R. BARD, INC.                   510(k) NO: K111100(SPECIAL)
ATTN: JUSTIN  LOVELACE            PHONE NO : 480 638 2915   
1415 WEST 3RD ST.                 SE DECISION MADE: 16-JUN-11
TEMPE AZ 85281 1740               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TULA IONTOPHORESIS SYSTEM
ACCLARENT, INC.                   510(k) NO: K110636(TRADITIONAL)
ATTN: GURVINDER  SINGH NANDA      PHONE NO : 650 687 5414   
1525-B O'BRIEN DR.                SE DECISION MADE: 16-JUN-11
MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELTA WOUND CLEANSER
SWISS AMERICAN PRODUCTS, INC.     510(k) NO: K103713(TRADITIONAL)
ATTN: ERIC  LUO                   PHONE NO : 972 385 2900   
2055 LUNA RD., STE. 126           SE DECISION MADE: 16-JUN-11
CARROLLTON TX 75006               510(k) STATEMENT

DEVICE: APEX K1 HIP STEM
OMNILIFE SCIENCE INC.             510(k) NO: K110947(SPECIAL)
ATTN: RADHIKA  PONDICHERRY        PHONE NO : 774 226 1852   
50 O'CONNELL WAY                  SE DECISION MADE: 16-JUN-11
EAST TAUNTON MA 02718             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC
FIAB S.P.A.                       510(k) NO: K103783(TRADITIONAL)
ATTN: ALBERTO  CALABRO            PHONE NO : 39 055 8497943
VIA COSTOLI, 4                    SE DECISION MADE: 16-JUN-11
VICCHIO     FLORENCE    IT 50039  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
PREMIER MEDICAL GLOVES FACTORY    510(k) NO: K111297(TRADITIONAL)
ATTN: LIANG  ZHAO                 PHONE NO : 865 362 197069
NO. 8-2, XING'AN RD., DONGCHENG, LSE DECISION MADE: 16-JUN-11
WEIFANG, SHANDONG    CH 262600    510(k) STATEMENT

DEVICE: BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX
GE MEDICAL SYSTEMS, LLC           510(k) NO: K103476(TRADITIONAL)
ATTN: NIDHI  CHAUDHARY            PHONE NO : 414 721 2899   
3000 N GRANDVIEW BLVD.            SE DECISION MADE: 16-JUN-11
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAXFIRE MARXMEN MENISCAL REPAIR DEVICE
BIOMET SPORTS MEDICINE            510(k) NO: K111564(SPECIAL)
ATTN: ELIZABETH  WRAY             PHONE NO : 574 371 1176   
56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 16-JUN-11
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
JIANGSU ALFA GLOVE CO., LTD       510(k) NO: K111459(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 86 108 2387441
RM.1606, BLDG.1 JIANXIANG YUAN NO.SE DECISION MADE: 16-JUN-11
HAI DIAN DISTRICT, BEIJING    CH 1510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDLINE EPIDURAL AND SPINAL NEEDLES
MEDLINE, INDUSTRIES, INC.         510(k) NO: K110194(TRADITIONAL)
ATTN: MATT  CLAUSEN               PHONE NO : 847 643 4785   
ONE MEDLINE PLACE                 SE DECISION MADE: 17-JUN-11
MUNDELEIN IL 60060                510(k) STATEMENT

DEVICE: TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
CAREFUSION 209, INC.              510(k) NO: K111131(SPECIAL)
ATTN: GLEN  HERMANSON             PHONE NO : 608 829 8606   
1850 Deming Way                   SE DECISION MADE: 17-JUN-11
Middleton WI 53562                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIT CHECKER ADVANCED
GC AMERICA, INC.                  510(k) NO: K110871(TRADITIONAL)
ATTN: MARK  HEISS                 PHONE NO : 708 897 4042   
3737 WEST 127TH ST.               SE DECISION MADE: 17-JUN-11
ALSIP IL 60803                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE
SMART MEDICAL SYSTEMS, LTD.       510(k) NO: K110291(SPECIAL)
ATTN: ADVA  YOSELZON              PHONE NO : 972 974 44478
10 HAYETSIRA STREET               SE DECISION MADE: 17-JUN-11
RAANANA    IS 43663               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRISMAFLEX
GAMBRO RENAL PRODUCTS, INC.       510(k) NO: K110823(TRADITIONAL)
ATTN: KAE  MILLER                 PHONE NO : 303 222 6724   
14143 DENVER WEST PARKWAY SUITE 40SE DECISION MADE: 17-JUN-11
LAKEWOOD CO 80401                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIXTEMP C&B
EXACTA DENTAL DIRECT, INC         510(k) NO: K102917(TRADITIONAL)
ATTN: RICHARD  KEEN               PHONE NO : 203 329 2700   
1151 HOPE STREET                  SE DECISION MADE: 17-JUN-11
STAMFORD CT 06907 1659            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM
ORTHOPEDIATRICS, CORP             510(k) NO: K111086(TRADITIONAL)
ATTN: MARK  FOX                   PHONE NO : 574 268 6379   
2850 FRONTIER DRIVE               SE DECISION MADE: 17-JUN-11
WARSAW IN 46582                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAFETYMATE TALKING FIRST AID
SAFETYMATE, INC.                  510(k) NO: K110625(TRADITIONAL)
ATTN: SHARON  COHEN, PH.D         PHONE NO : 949 722 1121   
1633 MONROVIA AVE                 SE DECISION MADE: 17-JUN-11
COSTA MCSA CA 92627               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CENTRIMAG RETURN CANNULA KIT
LEVITRONIX LLC.                   510(k) NO: K110980(TRADITIONAL)
ATTN: LYDIA  SAKAKEENY            PHONE NO : 781 466 6553   
45 FIRST AVE.                     SE DECISION MADE: 20-JUN-11
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908
EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K110509(TRADITIONAL)
ATTN: JAY  MANSOUR                PHONE NO : 678 908 8180   
845 ARONSON LAKE COURT            SE DECISION MADE: 20-JUN-11
ROSWELL GA 30075                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMATE STERILE ACUPUNCTURE NEEDLE
BIOMATE MEDICAL DEVICES TECHNOLOGY510(k) NO: K103061(TRADITIONAL)
ATTN: MICHAEL  LEE                PHONE NO : 886 228 096995
NO.45, MINSHENG RD. DANSHUI TOWN  SE DECISION MADE: 20-JUN-11
TAIPEI COUNTY    TW 251           510(k) STATEMENT

DEVICE: BIODESIGN NIPPLE RECONSTRUCTION CYLINDER
COOK BIOTECH, INC.                510(k) NO: K110402(TRADITIONAL)
ATTN: PERRY W GUINN               PHONE NO : 765 497 3355   
1425 INNOVATION PLACE             SE DECISION MADE: 20-JUN-11
WEST LAFAYETTE IN 47906 1000      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
IND DIAGNOSTICS INC.              510(k) NO: K110889(TRADITIONAL)
ATTN: KAI  LOU                    PHONE NO : 604 522 1619
1629 FOSTERS WAY                  SE DECISION MADE: 20-JUN-11
DELTA, BRITISH COLUMBIA    CA V3M 510(k) STATEMENT

DEVICE: CENTRIMAG DRAINAGE CANNULA KIT
LEVITRONIX LLC                    510(k) NO: K110983(TRADITIONAL)
ATTN: LYDIA  SAKAKEENY            PHONE NO : 781 466 6553   
45 FIRST AVE.                     SE DECISION MADE: 20-JUN-11
Waltham MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUVASIVE LONG LATERAL SPINAL SYSTEM
NUVASIVE, INC.                    510(k) NO: K111410(SPECIAL)
ATTN: ELIAS  KETCHUM              PHONE NO : 858 320 4588   
7475 LUSK BLVD                    SE DECISION MADE: 20-JUN-11
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT
ASTRA TECH AB                     510(k) NO: K101005(SPECIAL)
ATTN: LINDA  SCHULZ               PHONE NO : 858 792 1235   
11234 EL CAMINO REAL, SUITE 200   SE DECISION MADE: 21-JUN-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TENSCARE ITOUCH SURE MODEL ITS
TENSCARE LTD.                     510(k) NO: K103698(TRADITIONAL)
ATTN: ANDREW  BROWN               PHONE NO : 441 367 723434
9 BLENHEIM ROAD                   SE DECISION MADE: 21-JUN-11
EPSOM, SURREY    UK KT19 9BE      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH
ELITECHGROUP                      510(k) NO: K110830(TRADITIONAL)
ATTN: DEBRA K HUTSON              PHONE NO : 425 482 5174   
21720 23RD DR SE SUITE 150        SE DECISION MADE: 21-JUN-11
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
SONITUS MEDICAL INC               510(k) NO: K110831(TRADITIONAL)
ATTN: ROBERT J CHIN, PH.D.        PHONE NO : 650 593 5225   
25 HARTFORD AVENUE                SE DECISION MADE: 21-JUN-11
SAN CARLOS CA 94070               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
ORTHOFIX INC.                     510(k) NO: K110805(SPECIAL)
ATTN: MARY  BIGGERS               PHONE NO : 972 824 4624   
3451 PLANO PARKWAY                SE DECISION MADE: 21-JUN-11
LEWISVILLE TX 75056               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE
GALIL MEDICAL LTD.                510(k) NO: K110946(SPECIAL)
ATTN: LYNNE  DAVIES               PHONE NO : 651 287 5098
YOKNEAM GATE, 1 TAVOR BLDG.       SE DECISION MADE: 21-JUN-11
YOKNEAM    IS 20692               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CT-GUIDE NEEDLE GUIDANCE SYSTEM
ACTIVIEWS LTD                     510(k) NO: K110812(TRADITIONAL)
ATTN: JOHN J SMITH                PHONE NO : 202 637 3638   
555 THIRTEENTH STREET, NW         SE DECISION MADE: 21-JUN-11
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANASCIENT BREATH MONITOR
INVOY TECHNOLOGIES, LLC           510(k) NO: K110810(TRADITIONAL)
ATTN: LUBNA M AHMAD               PHONE NO : 602 721 0377   
1820 E.RAY ROAD                   SE DECISION MADE: 21-JUN-11
CHANDLER AZ 85225                 510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: QLAB 8.1 QUANTIFICATION SOFTWARE
PHILIPS ULTRASOUND, INC.          510(k) NO: K110414(TRADITIONAL)
ATTN: NANCY  BURKE                PHONE NO : 425 487 7371   
22100 BOTHELL EVERETT HWY.        SE DECISION MADE: 21-JUN-11
BOTHELL WA 98041                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042
EPS BIO TECHNOLOGY CORP.          510(k) NO: K102345(SPECIAL)
ATTN: Y.C.  LEI                   PHONE NO : 886 3 6686868
NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 21-JUN-11
HSINCHU CITY    TW 30077          510(k) STATEMENT

DEVICE: UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION
DEPUY ORTHOPAEDICS, INC.          510(k) NO: K111444(SPECIAL)
ATTN: SUZANA  OTANO               PHONE NO : 305 269 6386   
700 ORTHOPAEDIC DRIVE             SE DECISION MADE: 22-JUN-11
WARSAW IN 46581 0988              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROSCAN MICROSTEP
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K111394(TRADITIONAL)
ATTN: SHANNON  POPSON             PHONE NO : 916 374 3330   
1584 ENTERPRISE BLVD              SE DECISION MADE: 22-JUN-11
WEST SACRAMENTO CA 95691          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APEX PS KNEE SYSTEM - PS-C INSERT
OMNILIFE SCIENCE INC.             510(k) NO: K111184(SPECIAL)
ATTN: RADHIKA  PONDICHERRY        PHONE NO : 774 226 1852   
50 O'CONNELL WAY                  SE DECISION MADE: 22-JUN-11
EAST TAUNTON MA 02718             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALEUTIAN SPACER SYSTEM
K2M, INC.                         510(k) NO: K110843(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR. SE, SUITE F1       SE DECISION MADE: 22-JUN-11
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE PICC WAND (R) PEELABLE SAFETY INTRODUCER
ACCESS SCIENTIFIC, INC.           510(k) NO: K111138(SPECIAL)
ATTN: ALBERT  MISAJON             PHONE NO : 858 259 8333   
12526 HIGH BLUFF DRIVE SUITE 360  SE DECISION MADE: 22-JUN-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS
SMITH & NEPHEW, INC.              510(k) NO: K110647(TRADITIONAL)
ATTN: LAURA  REYNOLDS             PHONE NO : 727 329 7702   
970 LAKE CARILLON DR.             SE DECISION MADE: 22-JUN-11
ST. PETERSBURG FL 33716           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PALOMAR ICON (TM) AESTHETIC SYSTEM
PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K110907(TRADITIONAL)
ATTN: SHARON  TIMBERLAKE          PHONE NO : 781 993 2414   
15 NETWORK DRIVE                  SE DECISION MADE: 22-JUN-11
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORELEADER ALGIPLASTER MODEL AP 050501
CORELEADER BIOTECH CO., LTD.      510(k) NO: K102942(TRADITIONAL)
ATTN: IAN  LI                     PHONE NO : 886 226 968880
19F NO. 100, SEC 1 SINTAI 5TH RD, SE DECISION MADE: 22-JUN-11
TAIPEI, TAIWAN    TW 22102        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGIVISION INC. CLEARPOINT SYSTEM
SURGI-VISION, INC.                510(k) NO: K111073(TRADITIONAL)
ATTN: EDWARD  WADDELL             PHONE NO : 949 900 6833   
5 MUSICK                          SE DECISION MADE: 22-JUN-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE SENSITITRE AIM
TREK DIAGNOSTIC SYSTEMS           510(k) NO: K103456(TRADITIONAL)
ATTN: CYNTHIA C KNAPP             PHONE NO : 216 351 8735   
982 KEYNOTE CIRCLE                SE DECISION MADE: 22-JUN-11
CLEVELAND OH 44131                510(k) STATEMENT

DEVICE: CUTERA QSWITCH LASER SYSTEM
CUTERA, INC.                      510(k) NO: K102954(TRADITIONAL)
ATTN: CONNIE  HOY                 PHONE NO : 415 657 5592   
3240 BAYSHORE BLVD                SE DECISION MADE: 22-JUN-11
BRISBANE CA 94005                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
AALTO SCIENTIFIC LTD.             510(k) NO: K100716(TRADITIONAL)
ATTN: DESSI  LYAKOV               PHONE NO : 760 431 7922   
1959 KELLOGG AVE.                 SE DECISION MADE: 23-JUN-11
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WART FREEZE
KONINKLIJKE UTERMOHLEN NV         510(k) NO: K101049(TRADITIONAL)
ATTN: SHIRLEY  FURESZ             PHONE NO : 905 689 3980
4 INNOVATION DRIVE                SE DECISION MADE: 23-JUN-11
DUNDAS, ONTARIO    CA L9H 7P3     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACTIVE WASTE GAS SCAVENGER
G. DUNDAS CO.,INC.                510(k) NO: K110930(SPECIAL)
ATTN: MICHELLE  NORRIE            PHONE NO : 253 631 8008   
24301 ROBERTS DR.                 SE DECISION MADE: 23-JUN-11
BLACK DIAMOND WA 98010            510(k) STATEMENT

DEVICE: SURGICAL PROCEDURE PACKS
OMNIA SPA                         510(k) NO: K110724(TRADITIONAL)
ATTN: JAMIE  AUSTIN               PHONE NO : 317 569 9500   
11460 N MERIDIAN STREET SUITE 150 SE DECISION MADE: 23-JUN-11
CARMEL IN 46032                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INOMAX DS(IR) (DELIVERY SYSTEM)
INO THERAPEUTICS LLC/DBA IKARIA   510(k) NO: K110635(SPECIAL)
ATTN: LARRY  LEPLEY               PHONE NO : 608 226 3415   
2902 Dairy Dr                     SE DECISION MADE: 23-JUN-11
MADISON WI 53718                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISTA DIGITAL OPTHALMOSCOPE
EYEQUICK.LLC                      510(k) NO: K102412(TRADITIONAL)
ATTN: MARC  ELLMAN MD             PHONE NO : 915 490 1766   
1400 COMMON DRIVE                 SE DECISION MADE: 23-JUN-11
EL PASO,TX TX 79936               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STAT-MAT MINOR
MACPHERSON MEDICAL, INC.          510(k) NO: K110500(TRADITIONAL)
ATTN: HOWARD  HOLSTEIN            PHONE NO : 202 637 5813   
555 13TH STREET, NW COLUMBIA SQUARSE DECISION MADE: 23-JUN-11
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CUROS PORT PROTECTOR
IVERA MEDICAL                     510(k) NO: K110826(ABBREVIATED)
ATTN: DON  CANAL                  PHONE NO : 888 861 8228   
2731 Loker Avenue West            SE DECISION MADE: 23-JUN-11
Carlsbad CA 92010                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL
LIN-ZHI INTERNATIONAL, INC.       510(k) NO: K110239(TRADITIONAL)
ATTN: BERNICE  LIN                PHONE NO : 408 732 3856   
670 ALMANOR AVENUE                SE DECISION MADE: 23-JUN-11
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOUND SURGICAL VASER 2.1 LIPO SYSTEM
SOUND SURGICAL TECHNOLOGIES LLC.  510(k) NO: K110306(TRADITIONAL)
ATTN: STEPHEN C SMITH             PHONE NO : 720 240 2970   
357 S. MCCASLIN BLVD. #100        SE DECISION MADE: 23-JUN-11
LOUISVILLE CO 80027               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CENTURION PRESSURE INJECTABLE EXTENSION SET
CENTURION MEDICAL PRODUCTS CORPORA510(k) NO: K103562(ABBREVIATED)
ATTN: MATTHEW K PRICE             PHONE NO : 517 546 5400   
100 CENTURION WAY                 SE DECISION MADE: 23-JUN-11
WILLIAMSTON MI 48895              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE
NOBEL BIOCARE AB                  510(k) NO: K111581(SPECIAL)
ATTN: HERBERT  CRANE              PHONE NO : 714 282 4800   
22715 SAVI  RANCH PARKWAY         SE DECISION MADE: 23-JUN-11
YORBA LINDA CA 92887              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: METAL OPAQUER
APEX DENTAL MATERIALS, INC.       510(k) NO: K110859(TRADITIONAL)
ATTN: CHRIS  KULTON               PHONE NO : 847 719 1133   
330 TELSER ROAD                   SE DECISION MADE: 23-JUN-11
LAKE ZURICH IL 60047              510(k) STATEMENT

DEVICE: AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
MEDTRONIC, INC.                   510(k) NO: K111657(SPECIAL)
ATTN: LISA  STONE                 PHONE NO : 763 514 9866   
8200 CORAL SEA STREET NE          SE DECISION MADE: 23-JUN-11
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE THYROID COLLAR
BLOXR CORPORATION                 510(k) NO: K110900(TRADITIONAL)
ATTN: RAI  CHOWDHARY              PHONE NO : 385 646 7425   
2116 LAKE CITY                    SE DECISION MADE: 24-JUN-11
SALT LAKE CITY UT 84109           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIBERECT PENILE VIBRATORY STIMULATION DEVICE
REFLEXONIC, LLC                   510(k) NO: K110566(TRADITIONAL)
ATTN: CAROLINE  TONTINI           PHONE NO : 512 327 9997   
611 WEST 5TH STREET THIRD FLOOR   SE DECISION MADE: 24-JUN-11
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS)
SSC SURAT THANI                   510(k) NO: K111133(ABBREVIATED)
ATTN: WILLIAM E HARRIS , III      PHONE NO : 727 787 7250   
13900 49TH STREET NORTH           SE DECISION MADE: 24-JUN-11
CLEARWATER FL 33762               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IBAG
FUTURE PATH MEDICAL, LLC          510(k) NO: K110518(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 24-JUN-11
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOPSY HANDY, MRI BIOPSY HANDY
SOMATEX MEDICAL TECHNOLOGIES GMBH 510(k) NO: K102771(TRADITIONAL)
ATTN: SUSANNE  RAAB               PHONE NO : 617 547 0628   
1480 CAMBRIDGE STREET             SE DECISION MADE: 24-JUN-11
CAMBRIDGE MA 02139                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: F10
MEDIANA CO., LTD.                 510(k) NO: K110630(TRADITIONAL)
ATTN: AMY  M.H. KIM               PHONE NO : 823 374 25400
1650-1 DONGHWA-RI MUNMAK-CUP      SE DECISION MADE: 24-JUN-11
WONJU-CITY, GANGWON-DO    KS 220-8510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EPIDUCER LEAD DELIVERY SYSTEM
ST. JUDE MEDICAL                  510(k) NO: K110609(TRADITIONAL)
ATTN: RASHMI  MOZA                PHONE NO : 972 309 8055   
6901 PRESTON ROAD                 SE DECISION MADE: 24-JUN-11
PLANO TX 75024                    510(k) STATEMENT

DEVICE: MONACO RTP SYSTEM
COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K110730(TRADITIONAL)
ATTN: KATHRYN  STINSON            PHONE NO : 314 933 0003   
13723 RIVERPORT DR SUITE 100      SE DECISION MADE: 24-JUN-11
MARYLAND HEIGHTS MO 63043         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT
VANDUZEN DBA MEDCAD               510(k) NO: K110684(TRADITIONAL)
ATTN: DIANE  RUTHERFORD           PHONE NO : 972 480 9554   
1201 RICHARDSON SUITE 280         SE DECISION MADE: 24-JUN-11
RICHARDSON TX 75080               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MERIT MEDICAL 20 ML SYRINGE
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K111091(SPECIAL)
ATTN: MICHAELA  RIVKOWICH         PHONE NO : 801 208 4196   
1600 WEST MERIT PKWY.             SE DECISION MADE: 24-JUN-11
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSI
DIACOUSTIC MEDICAL DEVICES (PTY) L510(k) NO: K110704(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 888 729 9674   
1468 HARWELL AVENUE               SE DECISION MADE: 24-JUN-11
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
SMITH & NEPHEW, INC.              510(k) NO: K110545(TRADITIONAL)
ATTN: ELIZABETH  LAVELLE          PHONE NO : 508 261 3607   
150 MINUTEMAN RD.                 SE DECISION MADE: 24-JUN-11
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY
VASOMEDICAL, INC.                 510(k) NO: K111096(SPECIAL)
ATTN: RICHARD E GORDON            PHONE NO : 516 508 5821   
180 LINDEN AVE.                   SE DECISION MADE: 24-JUN-11
WESTBURY NY 11590                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INOMAX DSIR (DELIVERY SYSTEM)
INO THERAPEUTICS                  510(k) NO: K110344(SPECIAL)
ATTN: LARRY  LEPLEY               PHONE NO : 608 226 3415   
2902 DAIRY DRIVE                  SE DECISION MADE: 24-JUN-11
MADISON WI 53718                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CX50 DIAGNOSTIC ULTRASOUND SYSTEM
PHILIPS ULTRASOUND, INC.          510(k) NO: K111513(TRADITIONAL)
ATTN: PENNY  GRECO                PHONE NO : 978 659 4615   
3000  MINUTEMAN ROAD              SE DECISION MADE: 24-JUN-11
ANDOVER MA 01810 6302             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SUREFIRE INFUSION CATHETER SYSTEM
SUREFIRE MEDICAL, INC             510(k) NO: K110459(TRADITIONAL)
ATTN: CHERYL  HASTINGS            PHONE NO : 303 883 5554   
8601 TURNPIKE DR SUITE 206        SE DECISION MADE: 24-JUN-11
WESTMINISTER CO 80031             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUPRIS RETROPUBIC SLING SYSTEM
COLOPLAST A/S                     510(k) NO: K111233(SPECIAL)
ATTN: TIM  CRABTREE               PHONE NO : 612 302 4922   
1601 WEST RIVER ROAD N            SE DECISION MADE: 24-JUN-11
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPAX VOLUME VIEWING
AGFA HEALTHCARE N.V.              510(k) NO: K111638(TRADITIONAL)
ATTN: KOEN  COBBAERT              PHONE NO : 323 444 7539
SEPTESTRAAT 27                    SE DECISION MADE: 24-JUN-11
MORTSEL    BE B 2640              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K103520(TRADITIONAL)
ATTN: DARYL  RICHARDSON           PHONE NO : 949 250 5036   
ONE EDWARDS WAY                   SE DECISION MADE: 24-JUN-11
IRVINE CA 92614                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272  BLOOD GLUCOSE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K101509(TRADITIONAL)
ATTN: TELING  HSU                 PHONE NO : 886 266 258188
3F,5F, NO.127 WUGONG 2ND RD, WUGU SE DECISION MADE: 27-JUN-11
TAIPEI COUNTY    TW 24888         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONSENSUS KNEE SYSTEM
CONSENSUS ORTHOPEDICS, INC.       510(k) NO: K110950(TRADITIONAL)
ATTN: MATTHEW M HULL              PHONE NO : 916 355 7156   
1115 WINDFIELD WAY, SUITE 100     SE DECISION MADE: 27-JUN-11
EL DORADO HILLS CA 95762          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROFLU+ ASSAY
GEN-PROBE PRODESSE, INC           510(k) NO: K110968(TRADITIONAL)
ATTN: KAREN  HARRINGTON           PHONE NO : 262 953 8415   
W229 N1870 WESTWOOD DR            SE DECISION MADE: 27-JUN-11
WAUKESHA WI 53186                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APEX ARC HIP STEM
OMNILIFE SCIENCE INC.             510(k) NO: K111193(SPECIAL)
ATTN: RADHIKA  PONDICHERRY        PHONE NO : 774 226 1852   
50 O'CONNELL WAY                  SE DECISION MADE: 27-JUN-11
EAST TAUNTON MA 02718             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATIENT MONITOR
CONTEC MEDICAL SYSTEM CO., LTD.   510(k) NO: K101692(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 164 264467
SUITE 8D , ZHONGXIN ZHONGSHAN MANSSE DECISION MADE: 28-JUN-11
ZHONG SHAN, SHANGHAI    CH 200030 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DRYTOUCH SUCTION STIMULATOR PROBE
NEUROVISION MEDICAL PRODUCTS, INC.510(k) NO: K110712(TRADITIONAL)
ATTN: CHRISTINE  VERGELY          PHONE NO : 805 866 6999   
2225 SPERRY AVE, SUITE 1000       SE DECISION MADE: 28-JUN-11
VENTURA CA 93003                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IVAS 2-10MM (10 GUAGE) BALLON CATHETER
STRYKER CORPORATION               510(k) NO: K103807(TRADITIONAL)
ATTN: MELISSA  KANN               PHONE NO : 269 324 7700   
4100 E. MILHAM AVE                SE DECISION MADE: 28-JUN-11
KALAMAZOO MI 49001                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITAL SERUM CONTROLS
VITAL DIAGNOSTICS (MANUFACTURING) 510(k) NO: K111063(TRADITIONAL)
ATTN: MELITA  LAMBIRIS            PHONE NO : 613 879 36300
189-190 BROWNS ROAD               SE DECISION MADE: 28-JUN-11
NOBLE PARK  VICTORIA    AU 3174   510(k) STATEMENT

DEVICE: APTUS FOOT 3.5 SYSTEM
MEDARTIS AG                       510(k) NO: K110908(TRADITIONAL)
ATTN: KEVIN A THOMAS              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL, SUITE 200   SE DECISION MADE: 28-JUN-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER
HIGHLAND INSTRUMENTS              510(k) NO: K110752(TRADITIONAL)
ATTN: LEO  BASTA                  PHONE NO : 617 834 9866   
755 WESTMINSTER STREET UNIT 120   SE DECISION MADE: 28-JUN-11
PROVIDENCE RI 02903               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIPOLAR HF DEVICE
AESCULAP, INC.                    510(k) NO: K110695(TRADITIONAL)
ATTN: LISA M BOYLE                PHONE NO : 610 984 9274   
3773 CORPORATE PARKWAY            SE DECISION MADE: 28-JUN-11
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HALIFAX BIOMEDICAL TANATLUM BEAD SET
HALIFAX BIOMEDICAL, INC.          510(k) NO: K103417(SPECIAL)
ATTN: ROBERT A POGGIE, PHD        PHONE NO : 973 738 6097   
3 ELIZABETH PLACE                 SE DECISION MADE: 28-JUN-11
LAKE HOPATCONG NJ 07849           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INDIKO
THERMO FISHER SCIENTIFIC OY       510(k) NO: K110035(TRADITIONAL)
ATTN: PAIVI  SORMUNEN             PHONE NO : 358 932 910762
RATASTIE 2                        SE DECISION MADE: 28-JUN-11
VANTAA    FI 01620                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDART DIODE LASER SYSTEM & ACCESSORIES
MEDART A/S                        510(k) NO: K110243(TRADITIONAL)
ATTN: JOANNE  DAVIES              PHONE NO : 441 792 798768
CLOS LLYN CWM                     SE DECISION MADE: 28-JUN-11
SWANSEA, WALES    UK SA6 8QY      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY
VASOMEDICAL, INC.                 510(k) NO: K111180(SPECIAL)
ATTN: RICHARD E GORDON            PHONE NO : 516 508 5821   
180 LINDEN AVE.                   SE DECISION MADE: 28-JUN-11
WESTBURY NY 11590                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
MEDTRONIC INC.                    510(k) NO: K111658(SPECIAL)
ATTN: LISA  STONE                 PHONE NO : 763 514 9866   
8200 CORAL SEA ST NE              SE DECISION MADE: 28-JUN-11
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM
MEDTEC, INC.                      510(k) NO: K111340(TRADITIONAL)
ATTN: JENNY  JONES                PHONE NO : 712 737 8688   
1401 8TH STREET SE                SE DECISION MADE: 28-JUN-11
ORANGE CITY IA 51041              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASICO SOFTIP INJECTOR SYSTEM
ASICO LLC                         510(k) NO: K103495(TRADITIONAL)
ATTN: RAVI  NALLAKRISHNAN         PHONE NO : 630 986 8032   
26 PLAZA DR.                      SE DECISION MADE: 29-JUN-11
WESTMONT IL 60559                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: THERMO SCIENTIFIC MAS OMNI-IMMUNE,  MAS OMNI IMMUNE PRO
MICROGENICS CORP.                 510(k) NO: K110616(TRADITIONAL)
ATTN: LISA  CHARTER               PHONE NO : 510 979 5142   
46360 FREMONT BLVD                SE DECISION MADE: 29-JUN-11
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT
COOPERVISION, INC.                510(k) NO: K110099(TRADITIONAL)
ATTN: SARAH  HARRINGTON           PHONE NO : 925 621 2458   
6150 STONERIDGE MALL ROAD SUITE 37SE DECISION MADE: 29-JUN-11
PLEASANTON CA 94588               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORIN MINIHIP FEMORAL STEM
CORIN USA                         510(k) NO: K111046(SPECIAL)
ATTN: LUCINDA  GERBER             PHONE NO : 813 977 4469   
10500 UNIVERSITY CENTER DRIVE SUITSE DECISION MADE: 29-JUN-11
TAMPA FL 33612                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WAVEGUARD (TM) EEG CAP
EEMAGINE MEDICAL IMAGING SOLUTIONS510(k) NO: K110223(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 29-JUN-11
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAX ORIENT SUCTION DEVICE FOR ELECTROCAUTERIZER
PACIFIC HOSPITAL SUPPLY CO., LTD  510(k) NO: K111672(TRADITIONAL)
ATTN: IRENE  LIN                  PHONE NO : 886 228 955050
4F, NO. 160, DAYE RD, BEITOU DIST.SE DECISION MADE: 29-JUN-11
TAIPEI    TW 112                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: OCTANE-C INTERBODY FUSION DEVICE SYSTEM
EXACTECH, INC.                    510(k) NO: K103655(TRADITIONAL)
ATTN: PATRICK  HUGHES             PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 30-JUN-11
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EZONO 3000
LIFE-TECH, INC.                   510(k) NO: K102813(TRADITIONAL)
ATTN: SKIP  RIMER                 PHONE NO : 281 491 6600   
13235 NORTH PROMENADE BLVD.       SE DECISION MADE: 30-JUN-11
STAFFORD TX 77477                 510(k) STATEMENT

DEVICE: SCANORA 3D
SOREDEX PALODEX GROUP OY          510(k) NO: K110839(TRADITIONAL)
ATTN: MATTI  TULIKOURA            PHONE NO : 358 400 609507
NAHKELANTIE 160                   SE DECISION MADE: 30-JUN-11
TUUSULA    FI FIN-04300           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE
MEDLINE INDUSTRIES, INC.          510(k) NO: K102177(ABBREVIATED)
ATTN: MATT  CLAUSEN               PHONE NO : 847 643 4785   
ONE MEDLINE PLACE                 SE DECISION MADE: 30-JUN-11
MUNDELEIN IL 60060                510(k) STATEMENT

DEVICE: ENTERPRISE ELECTROPHYSIOLOGY SYSTEM
NEURALYNX INC                     510(k) NO: K110967(TRADITIONAL)
ATTN: MIKE  JOHNSON               PHONE NO : 406 585 4542   
105 COMMERCIAL DRIVE              SE DECISION MADE: 30-JUN-11
BOZEMAN MT 59715 2217             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROVU (TM) DENTAL X-RAY SYSTEM
ADVANCED IMAGE SCIENCE, INC.      510(k) NO: K102573(TRADITIONAL)
ATTN: PAUL  ROCKWELL              PHONE NO : 408 879 2619   
1999 SOUTH BASOM AVENUE, SUITE 700SE DECISION MADE: 30-JUN-11
CAMPBELL CA 95008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S8 ASPEN WITH H4I PLUS
RESMED CORP.                      510(k) NO: K111148(SPECIAL)
ATTN: DAVID  D'CRUZ               PHONE NO : 858 836 5984   
9001 SPECTRUM CENTER BOULEVARD    SE DECISION MADE: 30-JUN-11
KEARNY MESA CA 92123              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...
TELEFLEX MEDICAL, INC.            510(k) NO: K111117(SPECIAL)
ATTN: SUZANNE  SCHORLE            PHONE NO : 610 378 0131   
2400 BERNVILLE ROAD               SE DECISION MADE: 30-JUN-11
READING PA 19605                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GMD UNIVERSAL URINARY INCONTINENCE SLING
GENERIC MEDICAL DEVICE, INC.      510(k) NO: K111219(TRADITIONAL)
ATTN: JEFF  MORGAN                PHONE NO : 253 208 3430   
PO BOX 818                        SE DECISION MADE: 30-JUN-11
OCEAN SHORES WA 98569             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE
NORITAKE CO., INC.                510(k) NO: K111107(TRADITIONAL)
ATTN: IVAN  WASSERMAN             PHONE NO : 202 585 6529   
700 12 STREET, N.W., SUITE 1100   SE DECISION MADE: 30-JUN-11
WASHINGTON DC 20005               510(k) STATEMENT

DEVICE: CLIO/CLIOSOFT
SOTA PRECISION OPTICS, INC.       510(k) NO: K110886(TRADITIONAL)
ATTN: BRIAN  KIM                  PHONE NO : 714 532 6100   
1073 NORTH BATAVIA ST. SUITE B    SE DECISION MADE: 30-JUN-11
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIROCCO THERMAL REGULATING SYSTEM
GALMAZ BIOTECH S.L.               510(k) NO: K102856(TRADITIONAL)
ATTN: CHRIS  ZANDER               PHONE NO : 651 315 8304   
1064 LABARGE                      SE DECISION MADE: 30-JUN-11
HUDSON WI 54016                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ZYSTON ARC INTERBODY SPACER
BIOMET SPINE (AKA EBI, LLC)       510(k) NO: K110650(TRADITIONAL)
ATTN: MARGARET F CROWE            PHONE NO : 973 299 9300   
100 INTERPACE PARKWAY             SE DECISION MADE: 30-JUN-11
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K111485(TRADITIONAL)
ATTN: ERIC  ELLIOTT               PHONE NO : 763 494 2671   
ONE SCIMED PLACE                  SE DECISION MADE: 30-JUN-11
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003
BRIDGEPOINT MEDICAL               510(k) NO: K111488(SPECIAL)
ATTN: JILL  MUNSINGER             PHONE NO : 763 225 8500   
2800 CAMPUS DR STE 50             SE DECISION MADE: 30-JUN-11
PLYMOUTH MN 55441                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FATHOM (TM) 14 STEERABLE GUIDEWIRE
BOSTON SCIENTIFIC CORP.           510(k) NO: K111498(TRADITIONAL)
ATTN: ERIC  ELLIOTT               PHONE NO : 763 494 2671   
ONE SCIMED PLACE                  SE DECISION MADE: 30-JUN-11
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GC AADVA BO AC ABUTMENTS
GC AMERICA, INC.                  510(k) NO: K103234(TRADITIONAL)
ATTN: CARL  JENKINS               PHONE NO : 847 234 7500   
10 E. SCRANTON AVENUE SUITE 201   SE DECISION MADE: 30-JUN-11
LAKE BLUFF IL 60044               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUSON
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K111674(TRADITIONAL)
ATTN: SHELLY  PEARCE              PHONE NO : 650 694 5988   
1230 SHOREBIRD WAY                SE DECISION MADE: 30-JUN-11
MOUNTAIN VIEW CA 94043 1344       510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW


                                                 TOTAL 510(k)s THIS PERIOD   240                                     
                                                 TOTAL WITH SUMMARIES        221                                     
                                                 TOTAL WITH STATEMENTS        19