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U.S. Department of Health and Human Services

Medical Devices

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August 2011 510(k) Clearances

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


DEVICE: IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K101572(TRADITIONAL)
ATTN: CLARE  SANTULLI             PHONE NO : 914 524 2701   
511 BENEDICT AVENUE               SE DECISION MADE: 01-AUG-11
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20
A PLUS MEDICAL                    510(k) NO: K110383(TRADITIONAL)
ATTN: THOMAS C LOESCHER           PHONE NO : 760 930 0425   
5431 AVENIDA ENCINAS SUITE G      SE DECISION MADE: 01-AUG-11
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH
SMITH & NEPHEW, INC.              510(k) NO: K110958(TRADITIONAL)
ATTN: LAURA  REYNOLDS             PHONE NO : 727 329 7702   
970 LAKE CARILLON DR. SUITE 110   SE DECISION MADE: 01-AUG-11
ST. PETERSBURG FL 33716           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CURE CATHETER
CURE MEDICAL LLC.                 510(k) NO: K110653(TRADITIONAL)
ATTN: ROBYN  SCOPIS               PHONE NO : 949 262 0411   
3722 AVENUE SAUSALITO             SE DECISION MADE: 01-AUG-11
IRVINE CA 92606                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)
INTRICON DATRIX CORPORATION       510(k) NO: K111160(TRADITIONAL)
ATTN: TANYA  O'BRIEN              PHONE NO : 813 645 2855   
962 ALLEGRO LANE                  SE DECISION MADE: 01-AUG-11
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BENELLI ACCESS DEVICE
VASCULAR SOLUTIONS, INC.          510(k) NO: K111334(TRADITIONAL)
ATTN: JENNIFER  RUETHER           PHONE NO : 763 646 4300   
6464 SYCAMORE COURT               SE DECISION MADE: 01-AUG-11
MINNEAPOLIS MN 55369              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K111745(SPECIAL)
ATTN: CLAY  ANSELMO               PHONE NO : 303 223 4303   
555 ZANG STREET SUITE 100         SE DECISION MADE: 01-AUG-11
LAKEWOOD CO 80228                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRIMEWIRE PRESTIGE PLUS
VOLCANO CORPORATION               510(k) NO: K111395(SPECIAL)
ATTN: MARILYN  POURAZAR           PHONE NO : 858 720 4116   
3661 VALLEY CENTER DR SUITE 200   SE DECISION MADE: 01-AUG-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYPHILIS HEALTH CHECK
DIAGNOSTICS DIRECT, LLC.          510(k) NO: K102400(TRADITIONAL)
ATTN: GARY  LEHNUS                PHONE NO : 570 620 0198   
150 CHERRY LANE RD                SE DECISION MADE: 01-AUG-11
EAST STROUDSBURG PA 18301         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS
A&D COMPANY, LTD.                 510(k) NO: K111686(SPECIAL)
ATTN: JERRY  WANG                 PHONE NO : 408 518 5113   
1756 AUTOMATION PARKWAY           SE DECISION MADE: 01-AUG-11
SAN JOSE CA 9513                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONOLITH I-MOVE
EDAP TMS FRANCE                   510(k) NO: K111808(TRADITIONAL)
ATTN: HOLSTEIN  HOWARD            PHONE NO : 202 637 5813   
COLUMBIA SQUARE 555 THIRTEENTH STRSE DECISION MADE: 01-AUG-11
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: B1P ADHESIVE
PENTRON CLINICAL                  510(k) NO: K111431(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602   
1717 WEST COLLINS AVENUE          SE DECISION MADE: 01-AUG-11
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: "UNITED" U2 XPE TOTAL KNEE SYSTEM
UNITED ORTHOPEDIC CORPORATION     510(k) NO: K103733(TRADITIONAL)
ATTN: FANG-YUAN  HO               PHONE NO : 886 3 5773351
NO 57, PARK AVE 2, SCIENCE PARK   SE DECISION MADE: 02-AUG-11
HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR
GE HEALTHCARE FINLAND OY          510(k) NO: K103802(TRADITIONAL)
ATTN: TATJA  PASANEN              PHONE NO : 358 10 3942243
KUORTANEENKATU 2                  SE DECISION MADE: 02-AUG-11
HELSINKI    FI FIN-00510          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIGMA STERILIZATION POUCH & ROLL
SIGMA MEDICAL SUPPLIES CORP.      510(k) NO: K102158(TRADITIONAL)
ATTN: UTA  SHIH                   PHONE NO : 886 7 3113389
# 15-2, LN 26, MINEYUAN 1ST RD LINSE DECISION MADE: 02-AUG-11
KAOHSIUNG    TW 802               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANCHORWIRE GUIDEWIRE
LAKE REGION MEDICAL               510(k) NO: K111288(TRADITIONAL)
ATTN: MATHEW  PEXA                PHONE NO : 952 448 5111   
340 LAKE HAZELTINE DRIVE          SE DECISION MADE: 02-AUG-11
CHASKA MN 55318                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: LO-BAK TRAX
ROLAND F BERTHIAUME, DC           510(k) NO: K110858(TRADITIONAL)
ATTN: ROLAND F BERTHIAUME         PHONE NO : 413 896 2485   
585 COOLEY STREET                 SE DECISION MADE: 02-AUG-11
SPRINGFIELD MA 01128              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
DIRECT DIGITAL IMAGING TECHNOLOGY 510(k) NO: K110801(SPECIAL)
ATTN: LIKUN  FU                   PHONE NO : 861 088 856955
#33 BLDG. YUQUAN WISDOM VALE TSINGSE DECISION MADE: 02-AUG-11
BEIJING    CH 100097              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MESA SPINAL SYSTEM (KEYSTONE RODS)
K2M, INC.                         510(k) NO: K110991(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR.,SE SUITE F-1       SE DECISION MADE: 02-AUG-11
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX DISTAL EXTREMITY PLATE SYSTEM
ARTHREX, INC.                     510(k) NO: K111253(TRADITIONAL)
ATTN: COURTNEY  SMITH             PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 02-AUG-11
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM
PHYGEN, LLC                       510(k) NO: K110679(SPECIAL)
ATTN: HARTMUT  LOCH               PHONE NO : 949 752 7885   
2301 DUPONT DRIVE SUITE 510       SE DECISION MADE: 02-AUG-11
IRVINE CA 92612                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE
KUNSHAN JIEHONG NONWOVEN PRODUCT C510(k) NO: K111067(TRADITIONAL)
ATTN: GLEN  FEYE                  PHONE NO : 619 291 3695   
1340 WEST PENNSYLVANIA AVE        SE DECISION MADE: 02-AUG-11
SAN DIEGO CA 92103                510(k) STATEMENT

DEVICE: VANTAGE TITAN 3T
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K102489(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2241 MICHELLE DR                  SE DECISION MADE: 02-AUG-11
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VU C*POD INTERVERTEBRAL BODY FUSION DEVICE
THEKEN SPINE LLC                  510(k) NO: K111675(SPECIAL)
ATTN: DALE  DAVISON               PHONE NO : 330 239 7700   
1153 MEDINA RD.                   SE DECISION MADE: 02-AUG-11
MEDINA OH 44256 0000              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR
SHENZHEN DONGDIXIN TECHNOLOGY CO.,510(k) NO: K110707(TRADITIONAL)
ATTN: KANG JIAN  PING             PHONE NO : 86 755 27652471
NO. 3 BUILDING, XILIYIANGGUANG INDSE DECISION MADE: 03-AUG-11
SHENZHEN   GUANGDONG    CH 518108 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
ETHICON ENDO-SURGERY, INC.        510(k) NO: K111195(TRADITIONAL)
ATTN: DENNIS  HAHN                PHONE NO : 513 337 3134   
4545 CREEK RD.                    SE DECISION MADE: 03-AUG-11
CINCINNATI OH 45242 2839          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KNEEHAB XP
BIO-MEDICAL RESEARCH, LTD.        510(k) NO: K110350(TRADITIONAL)
ATTN: ANNE-MARIE  KEENAN          PHONE NO : 353 91 774300
PARKMORE BUSINESS PARK, WEST      SE DECISION MADE: 03-AUG-11
GALWAY    EI EI                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001
ATLAS MEDICAL                     510(k) NO: K102760(TRADITIONAL)
ATTN: NOUR  AL-AHWAL              PHONE NO : 962 640 26468
KING ABDULLAH II INDUS. ESTATE SAHSE DECISION MADE: 03-AUG-11
AMMAN    JO 11512                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TANDA MAX OTC SYSTEM
PHAROS LIFE CORPORATION           510(k) NO: K110735(TRADITIONAL)
ATTN: JOHNATHAN S KAHAN           PHONE NO : 202 637 5794   
555 THIRTEENTH ST., NW            SE DECISION MADE: 03-AUG-11
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BREEZE ELECTRIC TRANSPORT CHAIR MODEL 1025
ELECTRO KINETIC TECHNOLOGIES, LLC 510(k) NO: K111095(TRADITIONAL)
ATTN: RAYMOND  ERBE               PHONE NO : 262 250 7740   
W194N11301 MCCORMICK DRIVE        SE DECISION MADE: 03-AUG-11
GEMANTOWN WI 53022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000
MEDSHAPE SOLUTIONS                510(k) NO: K101934(TRADITIONAL)
ATTN: DON  GRIFFIN                PHONE NO : 404 583 6889   
1575 NORTHSIDE DR. SUITE 440      SE DECISION MADE: 03-AUG-11
ATLANTA GA 30318                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONSTRUX EXTERNAL FIXATION DEVICE
EBI, LLC                          510(k) NO: K111376(TRADITIONAL)
ATTN: MARGARET F CROWE            PHONE NO : 973 299 9300   
100 INTERPACE PKWY.               SE DECISION MADE: 03-AUG-11
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT
ERAGEN BIOSCIENCES, INC.          510(k) NO: K111527(TRADITIONAL)
ATTN: DAVID  LIM                  PHONE NO : 608 203 8919   
918 Deming Way, Suite 201         SE DECISION MADE: 03-AUG-11
Madison WI 53717 1944             510(k) STATEMENT

DEVICE: TELEMEDCARE HEALTH MONITOR
TELEMEDCARE PTY LTD               510(k) NO: K103796(TRADITIONAL)
ATTN: STEVEN M MOODY              PHONE NO : 614 285 47750
UNIT 7, 6-8 CREWE PLACE           SE DECISION MADE: 03-AUG-11
ROSEBERY, NEW SOUTH WALES    AS 20510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATRICURE CRYO MODULE SYSTEM
ATRICURE, INC.                    510(k) NO: K112072(TRADITIONAL)
ATTN: JAMES L LUCKY               PHONE NO : 513 755 5754   
6217 CENTRE PARK DRIVE            SE DECISION MADE: 03-AUG-11
WEST CHESTER OH 45069             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EKOSONIC ENDOVASCULAR SYSTEM
EKOS CORPORATION                  510(k) NO: K111705(TRADITIONAL)
ATTN: JOCELYN  KERSTEN            PHONE NO : 425 415 3132   
11911 North Creek Parkway Sout    SE DECISION MADE: 03-AUG-11
Bothell WA 98011                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE
SYNCRO MEDICAL INNOVATIONS, INC.  510(k) NO: K110005(SPECIAL)
ATTN: WILLIAM G MCLAIN            PHONE NO : 717 656 9656   
342 E MAIN STREET, SUITE 207      SE DECISION MADE: 04-AUG-11
LEOLA PA 17540                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER
BOSTON SCIENTIFIC CORP.           510(k) NO: K111043(TRADITIONAL)
ATTN: JANICE E BROWN, RAC         PHONE NO : 510 624 2582   
47900 BAYSIDE PARKWAY             SE DECISION MADE: 04-AUG-11
FREMONT CA 94538 6515             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AESCULAP SIBD XP SPINAL SYSTEM
AESCULAP IMPLANT SYSTEMS, INC.    510(k) NO: K111122(TRADITIONAL)
ATTN: LISA M BOYLE                PHONE NO : 610 984 9274   
3773 CORPORATE PWKY.              SE DECISION MADE: 04-AUG-11
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNITED UTF STEM
UNITED ORTHOPEDIC CORPORATION     510(k) NO: K110245(TRADITIONAL)
ATTN: FANG-YUAN  HO               PHONE NO : 886 357 73351
NO 57, PARK AVE 2, SCIENCE PARK   SE DECISION MADE: 04-AUG-11
HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)
NIHON KOHDEN CORP.                510(k) NO: K110410(TRADITIONAL)
ATTN: STEVE  GEERDES              PHONE NO : 949 580 1555   
90 ICON STREET                    SE DECISION MADE: 04-AUG-11
FOOTHILL RANCH CA 92610           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER
IQUUM INC                         510(k) NO: K111387(TRADITIONAL)
ATTN: LINGJUN  CHEN               PHONE NO : 508 970 0099   
700 NICKERSON ROAD                SE DECISION MADE: 04-AUG-11
MARLBOROUGH MA 01762 4663         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...
COVIDIEN                          510(k) NO: K111372(SPECIAL)
ATTN: WING  NG                    PHONE NO : 508 261 6596   
15 HAMPSHIRE STREET               SE DECISION MADE: 04-AUG-11
MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROSCAN(R) MICROSTREP PLUS(R)
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K111677(TRADITIONAL)
ATTN: JENIFER  DAWSON DRISCOLL    PHONE NO : 916 374 2545   
1584 ENTERPRISE BLVD.             SE DECISION MADE: 04-AUG-11
WEST SACRAMENTO CA 95691          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT)
STRYKER CORPORATION               510(k) NO: K111478(SPECIAL)
ATTN: TIFFANI  ROGERS             PHONE NO : 201 760 8206   
2 PEARL COURT                     SE DECISION MADE: 04-AUG-11
ALLENDALE NJ 07401                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORIN OPTIMOM MODULAR HEAD
CORIN U.S.A.                      510(k) NO: K111911(SPECIAL)
ATTN: LUCINDA  GERBER             PHONE NO : 813 977 4469   
10500 UNIVERSITY CENTER DR., SUITESE DECISION MADE: 04-AUG-11
TAMPA FL 33612                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERIMETER C SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K100967(TRADITIONAL)
ATTN: BRAD  SHEALS                PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 05-AUG-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY
SEDECAL S.A.                      510(k) NO: K101517(SPECIAL)
ATTN: DANIEL  KAMM, P.E.          PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 05-AUG-11
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOPEDIATRICS BLADE PLATE SYSTEM
ORTHOPEDIATRICS, CORP             510(k) NO: K110959(TRADITIONAL)
ATTN: MARK  FOX                   PHONE NO : 574 268 6379   
2850 FRONTIER DRIVE               SE DECISION MADE: 05-AUG-11
WARSAW IN 46582                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IBIS EXPLORER AND MARKUP SOFTWARE
MEDQIA                            510(k) NO: K111319(TRADITIONAL)
ATTN: MAHTAB  FATEMI              PHONE NO : 650 743 6848   
924 WESTWOOD BLVD SUITE 615       SE DECISION MADE: 05-AUG-11
LOS ANGELES CA 90024              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: HEADWAY 27 MICROCATHETER
MICRO VENTION, INC.               510(k) NO: K110813(SPECIAL)
ATTN: NAOMI  GONG                 PHONE NO : 714 247 8055   
1311 VALENCIA AVENUE              SE DECISION MADE: 05-AUG-11
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGICAL FACE MASK; SURGICAL FACE MASK
ANGELINE GROUP LTD.               510(k) NO: K110027(TRADITIONAL)
ATTN: MICHAEL  LEE                PHONE NO : 886 2 28096995
NO.45, MINSHENG RD DANSHUI TOWN   SE DECISION MADE: 05-AUG-11
TAIPEI COUNTY    TW 251           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREEWAY COMFORT BITE GUARD
RANDMARK DENTAL PRODUCTS, LLC     510(k) NO: K110468(TRADITIONAL)
ATTN: NORMAN F ESTRIN             PHONE NO : 301 279 2899   
9109 COPENHAVER DRIVE             SE DECISION MADE: 05-AUG-11
POTOMAC MD 20854                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRAINLAB TRAUMA
BRAINLAB AG                       510(k) NO: K110204(TRADITIONAL)
ATTN: ALEXANDER  SCHWIERSCH       PHONE NO : 498 999 15680
KAPELLENSTRASSE 12                SE DECISION MADE: 05-AUG-11
FELDKIRCHEN    GM 85622           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ST AIA-PACK DHEA-S CALIBRATOR SET
TOSOH BIOSCIENCE, INC.            510(k) NO: K111762(ABBREVIATED)
ATTN: JUDITH K OGDEN              PHONE NO : 650 636 8112   
6000 SHORELINE COURT SUITE 101    SE DECISION MADE: 05-AUG-11
SOUTH SAN FRANCISCO CA 94080      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K112054(SPECIAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DR                  SE DECISION MADE: 05-AUG-11
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECG-6 SERIES ELECTROCARDIOGRAPH
ADVANCED INSTRUMENTATIONS, INC.   510(k) NO: K112135(TRADITIONAL)
ATTN: JORGE  MILLAN               PHONE NO : 305 925 1260   
601 WEST 20 ST                    SE DECISION MADE: 05-AUG-11
HIALEAH FL 33010                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPAX NEXT GENERATION
AGFA HEALTHCARE N.V.              510(k) NO: K111945(TRADITIONAL)
ATTN: JODI  COLEMAN               PHONE NO : 519 746 6210
SEPTESTRAAT 27                    SE DECISION MADE: 05-AUG-11
MORTSEL    BE B 2640              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: GLIASITE RTS
ISORAY MEDICAL, INC.              510(k) NO: K111931(SPECIAL)
ATTN: FREDRIC G SWINDLER          PHONE NO : 509 375 1202   
350 HILLS ST., SUITE 106          SE DECISION MADE: 05-AUG-11
RICHLAND WA 99354 5411            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES
MAUNA KEA TECHNOLOGIES INC.       510(k) NO: K111047(SPECIAL)
ATTN: CHRIS  TIHANSKY             PHONE NO : 215 279 8415   
660 NEWTOWN-YARDLEY RD. SUITE 107 SE DECISION MADE: 08-AUG-11
NEWTON PA 18940                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS
INTRA-LOCK INTERNATIONAL, INC.    510(k) NO: K111199(TRADITIONAL)
ATTN: ANGELA  BLACKWELL           PHONE NO : 704 450 9934   
6560 WEST ROGERS CIRCLE           SE DECISION MADE: 08-AUG-11
BOCA RATON FL 33487               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANTLIA III WOUND TREATMENT SYSTEM
INNOVATIVE THERAPIES, INC.        510(k) NO: K111333(SPECIAL)
ATTN: JUDITH  HARBOUR             PHONE NO : 240 396 5500   
12 MEEM AVE, SUITE C              SE DECISION MADE: 08-AUG-11
GAITHERSBURG MD 20877             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR
ROG SPORTS MEDICINE, INC.         510(k) NO: K111590(SPECIAL)
ATTN: CURTIS  RAYMOND             PHONE NO : 203 922 0105   
80 SHELTON TECHNOLOGY CENTER      SE DECISION MADE: 08-AUG-11
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
SYNTHES (USA)                     510(k) NO: K111540(TRADITIONAL)
ATTN: THOMAS N SHEA               PHONE NO : 610 719 6809   
1301 GOSHEN PARKWAY               SE DECISION MADE: 08-AUG-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Y-KNOT ALL-SUTURE ANCHOR MODEL HF13
CONMED LINVATEC                   510(k) NO: K111779(TRADITIONAL)
ATTN: JOHN  CUSACK                PHONE NO : 727 399 5266   
11311 CONCEPT BOULEVARD           SE DECISION MADE: 08-AUG-11
LARGO FL 33773 4908               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP
STRYKER                           510(k) NO: K112059(SPECIAL)
ATTN: VALERIE  GIAMBANCO          PHONE NO : 201 831 6275   
325 CORPORATE DRIVE               SE DECISION MADE: 08-AUG-11
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
ABBOTT MOLECULAR, INC.            510(k) NO: K100015(TRADITIONAL)
ATTN: PAMELA L SWATKOWSKI         PHONE NO : 224 361 7013   
1300 EAST TOUHY AVENUE            SE DECISION MADE: 09-AUG-11
DES PLAINES IL 60018              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951
ANDON MEDICAL CO., LTD.           510(k) NO: K101307(TRADITIONAL)
ATTN: YI  LIU                     PHONE NO : 86 22 87612426
04-23-3 AIRPORT INDUSTRIAL PK     SE DECISION MADE: 09-AUG-11
TIANJIN    CH 300381              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRESCENT (R) SPINAL SYSTEM TITANIUM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K110543(SPECIAL)
ATTN: BECKY  RONNER               PHONE NO : 901 399 2757   
1800 PYRAMID PLACE                SE DECISION MADE: 09-AUG-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLLACARE DENTAL
INNOCOLL PHARMACEUTICALS LTD      510(k) NO: K110388(TRADITIONAL)
ATTN: AARON  WYSE                 PHONE NO : 353 090 6666091
MIDLANDS RESEARCH AND INNOVATION CSE DECISION MADE: 09-AUG-11
ATHLONE, CO. WESTMEATH    EI EI   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER
RESPIRONICS NEW JERSEY, INC.      510(k) NO: K110293(TRADITIONAL)
ATTN: LAUREN  ZIEGLER             PHONE NO : 973 581 6008   
5 WOOD HOLLOW ROAD                SE DECISION MADE: 09-AUG-11
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAVIAID(TM) BGC DEVICE
SMART MEDICAL SYSTEMS, LTD.       510(k) NO: K111760(SPECIAL)
ATTN: ADVA  YOSELZON              PHONE NO : 972 974 44321
10 HAYETSIRA STREET               SE DECISION MADE: 09-AUG-11
RAANANA    IS 43663               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE
ARTHROCARE CORPORATION            510(k) NO: K111044(TRADITIONAL)
ATTN: LAURA  KASPEROWICZ          PHONE NO : 949 585 2406   
15285 ALTON PARKWAY SUITE 209     SE DECISION MADE: 09-AUG-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: METASURG SUBTALAR IMPLANT
METASURG                          510(k) NO: K111265(TRADITIONAL)
ATTN: JOSHUA  SCOTT               PHONE NO : 281 398 5656   
16350 PARK TEN PL., SUITE 101     SE DECISION MADE: 09-AUG-11
HOUSTON TX 77084                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CYBOW READER, MODELS 300 & 720
DFI CO., LTD.                     510(k) NO: K102188(TRADITIONAL)
ATTN: YANG  HO-DONG               PHONE NO : 082 2 5663360
#821 SAMIL PLAZA, 837-26 YEUKSAM-DSE DECISION MADE: 09-AUG-11
GANGNAM-GU, SEOUL    KS 135-937   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAPPHIRE
ORBUSNEICH MEDICAL, INC.          510(k) NO: K103657(TRADITIONAL)
ATTN: JOHN  PAZIENZA              PHONE NO : 954 730 0711   
5363 N.W. 35TH AVE.               SE DECISION MADE: 09-AUG-11
FT. LAUDERDALE FL 33309 6315      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM
TEM INNOVATIONS GMBH              510(k) NO: K101533(TRADITIONAL)
ATTN: VOLKER-JOACHIM  FRIEMERT    PHONE NO : 498 945 42950
MARTIN-KOLLAR STR 13-15           SE DECISION MADE: 10-AUG-11
MUNICH, BAVARIA/UPPER BAVARIA    G510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
INNOVATIVE GLOVES CO; LTD         510(k) NO: K111158(TRADITIONAL)
ATTN: RAJEEV  SOOD                PHONE NO : 667 450 2251
830 MOO 4 SANAMBIN-BANKLANG RD KUASE DECISION MADE: 10-AUG-11
HATYAI, SONGKHLA    TH 90110      510(k) STATEMENT

DEVICE: SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (YELLOW / BLUE / WHITE / MAGENTA / CLEAR - NON COLORED)
SHANDONG BLUE SAIL INNOVATION CO.,510(k) NO: K103619(TRADITIONAL)
ATTN: YONGCHEN  ZHANG             PHONE NO : 865 363 658588
EAST SIDE OF XING'AN ROAD, DONGCHESE DECISION MADE: 10-AUG-11
WEIFANG, SHANDONG    CH 262600    510(k) STATEMENT

DEVICE: RALCO
RALCO S.R.L.                      510(k) NO: K110856(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 10-AUG-11
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN
HORIBA ABX S.A.S.                 510(k) NO: K110137(ABBREVIATED)
ATTN: CAROLINE  FERRER            PHONE NO : 330 467 141843
PARC EUROMEDECINE RUE DU CADUCEE-BSE DECISION MADE: 10-AUG-11
MONTPELLIER CEDEX 4, HERAULT    FR510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RADIOLOGICAL IMAGE PROCESSING SYSTEM
VATECH CO., LTD.                  510(k) NO: K102078(TRADITIONAL)
ATTN: DAVE  KIM                   PHONE NO : 832 623 2099   
333 MEADOWLANDS PARKWAY, #303     SE DECISION MADE: 10-AUG-11
SECAUCUS NJ 07094                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: C7 XR IMAGING SYSTEM
LIGHTLAB IMAGING,INC.             510(k) NO: K111201(TRADITIONAL)
ATTN: BRYAN  COWELL               PHONE NO : 978 692 1000   
ONE TECHNOLOGY PARK DRIVE         SE DECISION MADE: 10-AUG-11
WESTFORD MA 01886                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
SYNTHES (USA) PRODUCTS LLC        510(k) NO: K111437(TRADITIONAL)
ATTN: ANGELA F LASSANDRO          PHONE NO : 610 719 6854   
1301 GOSHEN PKWY.                 SE DECISION MADE: 10-AUG-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER
BRIDGEPOINT MEDICAL               510(k) NO: K111963(SPECIAL)
ATTN: JILL  MUNSINGER             PHONE NO : 763 225 8500   
2800 CAMPUS DR STE 50             SE DECISION MADE: 10-AUG-11
PLYMOUTH MN 55441                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)
INFIMED, INC.                     510(k) NO: K112180(SPECIAL)
ATTN: CATHERINE  MULCAHY          PHONE NO : 315 453 4545   
121 METROPOLITAN DR.              SE DECISION MADE: 10-AUG-11
LIVERPOOL NY 13088                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUCINA MODEL MELODI
GENADYNE BIOTECHNOLOGIES, INC.    510(k) NO: K102516(TRADITIONAL)
ATTN: CHIEN  MING(ANDREW)GOH      PHONE NO : 800 208 2025   
65 WATERMILL LANE                 SE DECISION MADE: 11-AUG-11
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIO COLOR 2MP
BARCO NV                          510(k) NO: K111991(TRADITIONAL)
ATTN: LIEVEN  DE WANDEL           PHONE NO : 325 623 3459
35 PRESIDENT KENNEDYPARK          SE DECISION MADE: 11-AUG-11
KORTRIJK    BE 8500               510(k) STATEMENT

DEVICE: UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
ZIMMER SPINE                      510(k) NO: K110348(TRADITIONAL)
ATTN: ELSA A LINKE                PHONE NO : 952 830 6205   
7375 BUSH LAKE ROAD               SE DECISION MADE: 11-AUG-11
EDINA MN 55439                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
SPINEART                          510(k) NO: K111127(SPECIAL)
ATTN: FRANCK  PENNESI             PHONE NO : 412 279 94025
COINTRIN 20 ROUTE DE PRE-BOIS CP18SE DECISION MADE: 11-AUG-11
GENEVA    SZ 1215                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORIGIN ZIRCONIA
B&D DENTAL TECHNOLOGIES           510(k) NO: K110719(ABBREVIATED)
ATTN: JOON  HWANG                 PHONE NO : 801 214 3005   
2371 S. PRESIDENTS DR., STE. E    SE DECISION MADE: 11-AUG-11
WEST VALLEY UT 84119              510(k) STATEMENT

DEVICE: DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES
STARBOARD MEDICAL, LLC            510(k) NO: K111282(TRADITIONAL)
ATTN: ANTHONY  BERAN              PHONE NO : 714 283 3099   
22845 SAVI RANCH PKWY SUITE H     SE DECISION MADE: 11-AUG-11
Yorba Linda CA 92887              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EEVATM PETRI DISH
AUXOGYN, INC.                     510(k) NO: K103028(TRADITIONAL)
ATTN: ROBERT  NEWMAN              PHONE NO : 650 641 2429   
1490 O'BRIEN DRIVE SUITE A        SE DECISION MADE: 11-AUG-11
MENLO PARK CA 94545               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFILL GRAFT DELIVERY SYSTEM
PINNACLE SPINE GROUP, LLC         510(k) NO: K111632(TRADITIONAL)
ATTN: REBECCA K SPINE             PHONE NO : 760 809 5178   
1601 ELM STREET, SUITE 300        SE DECISION MADE: 11-AUG-11
DALLAS TX 75201                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMBRYOSCOPE
UNISENSE FERTILITECH A/S          510(k) NO: K111715(TRADITIONAL)
ATTN: METTE  MUNCH                PHONE NO : 458 944 520
TUEAGER 1                         SE DECISION MADE: 11-AUG-11
ARRHUS N    DA DK-8200            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANODIZED HEALING COLLAR
ZIMMER DENTAL INC.                510(k) NO: K111852(SPECIAL)
ATTN: MELISSA  BURBAGE            PHONE NO : 760 929 4300   
1900 ASTON AVE.                   SE DECISION MADE: 11-AUG-11
CARLSBAD CA 92008 7308            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASCAL STREAMLINE 577 (WITH ACCESSORIES)
TOPCON MEDICAL LASER SYSTEMS, INC 510(k) NO: K111108(TRADITIONAL)
ATTN: JOHN  JOSSY                 PHONE NO : 408 235 8202   
3130 CORONADO DRIVE               SE DECISION MADE: 11-AUG-11
SANTA CLARA CA 95054              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WILDCAT CATHETER
AVINGER, INC.                     510(k) NO: K111338(TRADITIONAL)
ATTN: KIT  CARIQUITAN             PHONE NO : 408 400 0856   
755 MATHILDA AVENUE SUITE 100     SE DECISION MADE: 11-AUG-11
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)
SOFRADIM PRODUCTION               510(k) NO: K110663(TRADITIONAL)
ATTN: JAMES  MCMAHON              PHONE NO : 781 839 1787   
15 CROSBY DRIVE                   SE DECISION MADE: 11-AUG-11
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITEK 2 AST-ST LINEZOLID
BIOMERIEUX, INC.                  510(k) NO: K111599(TRADITIONAL)
ATTN: NATHAN  HARDESTY            PHONE NO : 314 731 8666   
595 ANGLUM RD.                    SE DECISION MADE: 12-AUG-11
HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRIVO XR385
GE MEDICAL SYSTEMS, LLC           510(k) NO: K103448(TRADITIONAL)
ATTN: JOHN L SCHMIDT              PHONE NO : 262 548 4964   
3000 N GRANDVIEW BLVD.            SE DECISION MADE: 12-AUG-11
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENTRYSUITE PRODUCT LINE
CAREFUSION GERMANY 234 GMBH       510(k) NO: K111053(TRADITIONAL)
ATTN: ELMAR  NIEDERMEYER          PHONE NO : 499 314 972361
LEIBNIZSTRASSE 7                  SE DECISION MADE: 12-AUG-11
HOECHBERG, BAVARIA    GM 97204    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCUSOM
NOVASOM, INC.                     510(k) NO: K110486(TRADITIONAL)
ATTN: ROGER K RICHARDSON          PHONE NO : 410 590 0443   
801 CROMWELL PARK DRIVE           SE DECISION MADE: 12-AUG-11
GLEN BURNIE MD 21061              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER
MARVAO MEDICAL DEVICES, LTD.      510(k) NO: K110627(TRADITIONAL)
ATTN: MARYBETH  GAMBER            PHONE NO : 508 351 8632   
368 WEST MAIN STREET SUITE 7      SE DECISION MADE: 12-AUG-11
NORTHBORO MA 01532                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)
PT. MAHAKARYA INTI BUANA          510(k) NO: K111300(TRADITIONAL)
ATTN: LINA  NG                    PHONE NO : 62 61 30007150
DALU 10, DELI SERDANG T. MORAWA   SE DECISION MADE: 12-AUG-11
SUMATERA UTARA    ID 20362        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
STERIS CORPORATION                510(k) NO: K102330(TRADITIONAL)
ATTN: ROBERT F SULLIVAN           PHONE NO : 440 392 7695   
5960 HEISLEY ROAD                 SE DECISION MADE: 12-AUG-11
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS
STRAUMANN USA                     510(k) NO: K110580(TRADITIONAL)
ATTN: ELAINE  ALAN                PHONE NO : 978 747 2513   
60 MINUTEMAN ROAD                 SE DECISION MADE: 12-AUG-11
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KIDS ROCK 3 CHAIR
PRIDE MOBILITY PRODUCTS CORP.     510(k) NO: K111739(SPECIAL)
ATTN: KIMBERLY  BLAKE             PHONE NO : 570 655 5574   
182 SUSQUEHANNA AVE.              SE DECISION MADE: 12-AUG-11
EXETER PA 18643                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
BOSTON SCIENTIFIC CORP.           510(k) NO: K112103(SPECIAL)
ATTN: HARLAN  JONES               PHONE NO : 763 255 0027   
ONE SCIMED PLACE                  SE DECISION MADE: 12-AUG-11
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NITRILE POWDER FREE EXAMINATION GLOVES
HARTALEGA SDN BHD                 510(k) NO: K110758(TRADITIONAL)
ATTN: NURUL AISYAH  KONG BT ABDULLPHONE NO : 603 327 10277X2200
NO. 7, KAWASAN PERUSAHAAN SURIA   SE DECISION MADE: 12-AUG-11
BESTARI JAYA, SELANGOR    MY 45600510(k) STATEMENT

DEVICE: NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202
HSINER CO., LTD.                  510(k) NO: K102120(TRADITIONAL)
ATTN: TOM  SHANKS                 PHONE NO : 951 506 2674   
29201 VIA NORTE                   SE DECISION MADE: 12-AUG-11
TEMECULA CA 92591                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
CAREFUSION 209, INC.              510(k) NO: K112034(SPECIAL)
ATTN: GLEN  HERMANSON             PHONE NO : 608 829 8606   
1850 Deming Way                   SE DECISION MADE: 12-AUG-11
Middleton WI 53562                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIRPRIME
NORITAKE CO., INC.                510(k) NO: K111383(TRADITIONAL)
ATTN: IVAN  WASSERMAN             PHONE NO : 202 585 6529   
700 12 STREET, N.W., SUITE 1100   SE DECISION MADE: 12-AUG-11
WASHINGTON DC 20005               510(k) STATEMENT

DEVICE: ISROBOT MONA LISA
BIOBOT SURGICAL PTE LTD           510(k) NO: K111347(TRADITIONAL)
ATTN: CHERITA  JAMES              PHONE NO : 703 562 9800   
901 KING ST SUITE 200             SE DECISION MADE: 12-AUG-11
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC
EXACTECH, INC.                    510(k) NO: K103699(TRADITIONAL)
ATTN: SHING JEN  TAI, PHD         PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 12-AUG-11
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDILED MINI
MEDIX I.C.S.A.                    510(k) NO: K103735(TRADITIONAL)
ATTN: JAMES H KNAUSS              PHONE NO : 832 675 9281   
11874 SOUTH EVELYN CIRCLE         SE DECISION MADE: 15-AUG-11
HOUSTON TX 77071 3404             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRANIAL REMOLDING ORTHOSIS
ORTHOTIC CARE SERVICES, LLP       510(k) NO: K111247(TRADITIONAL)
ATTN: SCOTT  HINSHON              PHONE NO : 651 291 9000   
360 SHERMAN STREET, SUITE 299     SE DECISION MADE: 15-AUG-11
ST.PAUL MN 55102                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
OSTEOMED L.P.                     510(k) NO: K111176(SPECIAL)
ATTN: PIEDAD  PENA                PHONE NO : 972 677 4600   
3885 ARAPAHO RD.                  SE DECISION MADE: 15-AUG-11
ADDISON TX 75001                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAPIDPOINT 405 NEONATAL BILIRUBIN
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K110277(TRADITIONAL)
ATTN: STEVEN  GOLDBERG            PHONE NO : 781 269 3941   
2 EDGEWATER DRIVE                 SE DECISION MADE: 15-AUG-11
NORWOOD MA 02062                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ION HEALTH USB INSTA-SCAN THERMOMETER
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K111974(SPECIAL)
ATTN: TELING  HSU                 PHONE NO : 886 266 258188
3F,5F, NO.127 WUGONG 2ND RD, WUGU SE DECISION MADE: 15-AUG-11
NEW TAIPEI CITY    TW 24888       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)
OMEGA LABORATORIES, INC.          510(k) NO: K101973(TRADITIONAL)
ATTN: ROBERT J BARD               PHONE NO : 248 563 5040   
PO BOX 506                        SE DECISION MADE: 16-AUG-11
SOUTH LYON MI 48178               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDO HEAD
MEDACTA INTERNATIONAL             510(k) NO: K111145(TRADITIONAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 437 7085   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 16-AUG-11
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRUMATCH PERSONALIZED SOLUTIONS
DEPUY ORTHOPAEDICS, INC.          510(k) NO: K110397(TRADITIONAL)
ATTN: NANCY S FRIDDLE             PHONE NO : 574 371 4923   
700 ORTHOPAEDIC DRIVE             SE DECISION MADE: 16-AUG-11
WARSAW IN 46581 0988              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HAIRMAX DUAL 12
LEXINGTON INTERNATIONAL, LLC      510(k) NO: K111714(TRADITIONAL)
ATTN: CASPER E ULDRICKS ESQ.      PHONE NO : 202 518 6385   
1400 SIXTEENTH STREET, NW SUITE 40SE DECISION MADE: 16-AUG-11
WASHINGTON DC 20036               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
NOVA BIOMEDICAL CORP.             510(k) NO: K100602(TRADITIONAL)
ATTN: PAUL W MACDONALD            PHONE NO : 781 894 0800   
200 PROSPECT ST.                  SE DECISION MADE: 17-AUG-11
WALTHAM MA 02454 9141             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CHEMISTRY FERRITIN (FRT) METHOD
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K110736(TRADITIONAL)
ATTN: KIRA  GORDON                PHONE NO : 914 524 2996   
511 BENEDICT AVENUE               SE DECISION MADE: 17-AUG-11
TARRYTOWN NY 10509                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM
OSTIAL CORPORATION                510(k) NO: K111284(TRADITIONAL)
ATTN: MARK  SMUTKA                PHONE NO : 650 903 9100   
510 CLYDE AVENUE                  SE DECISION MADE: 17-AUG-11
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)
K2M, INC.                         510(k) NO: K111135(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR.,SE                 SE DECISION MADE: 17-AUG-11
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZOLL E SERIES
ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K111594(TRADITIONAL)
ATTN: CHUCK  KOLIFRATH            PHONE NO : 978 421 9786   
269 MILL ROAD                     SE DECISION MADE: 17-AUG-11
CHELMSFORD MA 01824 4105          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT
COLOPLAST A/S                     510(k) NO: K111881(TRADITIONAL)
ATTN: JANELL A COLLEY             PHONE NO : 612 287 4211   
1601 WEST RIVER ROAD N            SE DECISION MADE: 17-AUG-11
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIBERNET EMBOLIC PROTECTION DEVICE
LUMEN BIOMEDICAL, INC.            510(k) NO: K111987(SPECIAL)
ATTN: MICHELLE  STRAIGHT          PHONE NO : 763 746 9551   
10900 73RD AVE NORTH SUITE 150    SE DECISION MADE: 17-AUG-11
MAPLE GROVE MN 55369              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVOLVE ADDITIONAL IMPLANTS
GLOBUS MEDICAL, INC.              510(k) NO: K111449(SPECIAL)
ATTN: SARAH MARIE  FITZGERALD     PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE. VALLEYSE DECISION MADE: 17-AUG-11
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
TELEFLEX MEDICAL, INC.            510(k) NO: K111900(TRADITIONAL)
ATTN: SUZANNE  SCHORLE            PHONE NO : 610 378 0131   
2400 BERNVILLE ROAD               SE DECISION MADE: 17-AUG-11
READING PA 19605                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K111083(ABBREVIATED)
ATTN: MICHAEL  ASMALSKY           PHONE NO : 497 031 4631277
HEWLETT-PACKARD STR.2             SE DECISION MADE: 17-AUG-11
BOEBLINGEN    GM D 71034          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018" GUIDE WIRE 6100-XXXXX, 6100CB-XXXX
TRIREME MEDICAL, INC.             510(k) NO: K112281(TRADITIONAL)
ATTN: SHIVA  ARDAKANI             PHONE NO : 925 931 1300   
7060 Koll Center Parkway Suite 300SE DECISION MADE: 17-AUG-11
Pleasanton CA 94566               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: REVERE CROSSTOP
GLOBUS MEDICAL INC.               510(k) NO: K111479(SPECIAL)
ATTN: SARAH M FITZGERALD          PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 17-AUG-11
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CROSSER RECANALIZATION SYSTEM
C.R. BARD, INC.                   510(k) NO: K112308(TRADITIONAL)
ATTN: TIMOTHY  WADE               PHONE NO : 480 638 2939   
745 N. PASTORIA AVE               SE DECISION MADE: 17-AUG-11
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING
SENTINELLE MEDICAL, INC.          510(k) NO: K103274(TRADITIONAL)
ATTN: CAMERON  PIRON              PHONE NO : 647 258 3601
555 RICHMOND STREET W SUITE 800, PSE DECISION MADE: 18-AUG-11
TORONTO, ONTARIO    CA M5V 3B1    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: IMC INSULIN SYRINGE
INTERNATIONAL MEDSURG CONNECTION  510(k) NO: K110882(TRADITIONAL)
ATTN: PETER  KIM                  PHONE NO : 847 619 9926   
935 N. PLUM GROVE ROAD, SUITE F   SE DECISION MADE: 18-AUG-11
SCHAUMBURG IL 60173               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER
STERILMED, INC.                   510(k) NO: K110076(TRADITIONAL)
ATTN: GARRETT  AHLBORG            PHONE NO : 763 488 3483   
11400 73RD AVE. NORTH             SE DECISION MADE: 18-AUG-11
MAPLE GROVE MN 55369 5562         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXIS-SHIELD ANTI-CCP
AXIS-SHIELD DIAGNOSTICS, LTD.     510(k) NO: K110296(TRADITIONAL)
ATTN: CLAIRE I DORA               PHONE NO : 441 382 422000
THE TECHNOLOGY PARK LUNA PLACE    SE DECISION MADE: 18-AUG-11
DUNDEE, SCOTLAND    UK DD2 1XA    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMC BLOOD COLLECTION NEEDLE
INTERNATIONAL MEDSURG CONNECTION  510(k) NO: K110656(TRADITIONAL)
ATTN: PETER  KIM                  PHONE NO : 847 619 9926   
935 N PLUM GROVE ROAD SUITE F     SE DECISION MADE: 18-AUG-11
SCHAUMBURG IL 60173               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT
VELOPEX INTERNATIONAL, INC.       510(k) NO: K111167(TRADITIONAL)
ATTN: ANTHONY  URELLA             PHONE NO : 407 957 3900   
105 EAST 17TH ST.                 SE DECISION MADE: 18-AUG-11
ST. CLOUD FL 34769                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CS 9300, CS 9300C
TROPHY                            510(k) NO: K103659(TRADITIONAL)
ATTN: MARIE-PIERRE  LABAT-CAMY    PHONE NO : 331 648 08500
4 RUE F. PELLOUTIER CROISSY BEAUBOSE DECISION MADE: 18-AUG-11
MARNE LA VALLEE CEDEX 2    FR 7743510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMR REVERSE SHOULDER SYSTEM
LIMACORPORATE S.P.A.              510(k) NO: K110598(TRADITIONAL)
ATTN: CHERYL  HASTINGS            PHONE NO : 574 527 4220   
P.O. BOX 696                      SE DECISION MADE: 18-AUG-11
WINONA LAKE IN 46590 696          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRUEBEAM
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K111106(TRADITIONAL)
ATTN: VY  TRAN                    PHONE NO : 650 424 5731   
3100 HANSEN WAY                   SE DECISION MADE: 18-AUG-11
PALO ALTO CA 94304                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM
STERIS CORPORATION                510(k) NO: K102394(TRADITIONAL)
ATTN: ROBERT  SULLIVAN            PHONE NO : 440 354 2600   
5960 HEISLEY ROAD                 SE DECISION MADE: 18-AUG-11
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACE TRIMARK TRICAM DENTAL IMPLANT
ACE SURGICAL SUPPLY COMPANY INC.  510(k) NO: K103790(TRADITIONAL)
ATTN: DENISE  WILLIAMS            PHONE NO : 508 588 3100   
1034 PEARL ST.                    SE DECISION MADE: 18-AUG-11
BROCKTON MA 02401                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM...
MEDLINE INDUSTRIES, INC.          510(k) NO: K111807(TRADITIONAL)
ATTN: MATT  CLAUSEN               PHONE NO : 847 643 4785   
ONE MEDLINE PLACE                 SE DECISION MADE: 18-AUG-11
MUNDELEIN IL 60060                510(k) STATEMENT

DEVICE: SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...
TREK DIAGNOSTIC SYSTEMS, LTD.     510(k) NO: K111429(TRADITIONAL)
ATTN: CYNTHIA C KNAPP             PHONE NO : 216 351 8735   
982 KEYNOTE CIRCLE SUITE 6        SE DECISION MADE: 18-AUG-11
CLEVELAND OH 44131                510(k) STATEMENT

DEVICE: SYNGO.CT VASCULAR ANALYSIS
SIEMENS MEDICAL SOLUTIONS, INC.   510(k) NO: K112020(TRADITIONAL)
ATTN: RALF  HOFMANN               PHONE NO : 49 919 1188170
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 18-AUG-11
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK
TECHLAB INC., CORPORATE RESEARCH C510(k) NO: K103673(TRADITIONAL)
ATTN: DONNA T LINK                PHONE NO : 540 953 1664   
2001 KRAFT DR.                    SE DECISION MADE: 18-AUG-11
BLACKSBURG VA 24060 6358          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFOSEND GSM
FISHER & PAYKEL HEALTHCARE, LTD.  510(k) NO: K110316(TRADITIONAL)
ATTN: JAMES  THOMPSON             PHONE NO : 649 574 0123
15 MAURICE PAYKEL PLACE, EAST TAMASE DECISION MADE: 19-AUG-11
AUCKLAND    NZ 1701               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR
BIOMET SPORTS MEDICINE            510(k) NO: K110879(TRADITIONAL)
ATTN: ELIZABETH  WRAY             PHONE NO : 574 371 1176   
56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 19-AUG-11
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRIMED RADIOCARPAL FUSION SYSTEM
TRIMED, INC.                      510(k) NO: K102785(TRADITIONAL)
ATTN: DAVID  ANDERSON             PHONE NO : 661 312 7150   
28337 MAITLAND LANE               SE DECISION MADE: 19-AUG-11
SAUGUS CA 91350                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TL-CERMIDE SKIN BARRIER EMULSION
TRIGEN LABORATORIES, INC.         510(k) NO: K110757(TRADITIONAL)
ATTN: GEORGE  MCCAULEY            PHONE NO : 803 831 7657   
248 LATITUDE LANE SUITE 104       SE DECISION MADE: 19-AUG-11
LAKE WYLIE SC 29710               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CKMB UDR ASSAY
SENTINEL CH. SPA                  510(k) NO: K102706(TRADITIONAL)
ATTN: FABIO  ROTA                 PHONE NO : 390 234 551448
VIA ROBERT KOCH, 2                SE DECISION MADE: 19-AUG-11
MILANO    IT 20152                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STAXX XDL SYSTEM
SPINE WAVE, INC.                  510(k) NO: K102315(TRADITIONAL)
ATTN: DENISE  DUCHENE             PHONE NO : 203 712 1847   
THREE  ENTERPRISE DR. SUITE 210   SE DECISION MADE: 19-AUG-11
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: V200 INTELLI-TRAK OPTION
RESPIRONICS CALIFORNIA, INC.      510(k) NO: K110795(TRADITIONAL)
ATTN: ROBERT M MARSHALL           PHONE NO : 724 327 0230   
3919 WILLIAM PENN HIGHWAY, SUITE 2SE DECISION MADE: 19-AUG-11
MURRYSVILLE PA 15668 8550         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SILK'N FX
HOME SKINOVATIONS LTD.            510(k) NO: K110301(TRADITIONAL)
ATTN: AMIR  WALDMAN PH. D.        PHONE NO : 972 547 404616
TAVOR BULD. POB 533               SE DECISION MADE: 19-AUG-11
YOKNEAM ILLIT    IS 20692         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONAFINE WOUND DRESSING
STRATUS PHARMACEUTICAL            510(k) NO: K110172(TRADITIONAL)
ATTN: ALBERTO  HOYO               PHONE NO : 305 254 6793   
12379 SW 130TH STREET             SE DECISION MADE: 19-AUG-11
MIAMI FL 33186                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RSI 4200
REIMERS SYSTEMS, INC.             510(k) NO: K102831(ABBREVIATED)
ATTN: NAYIL  ALAM                 PHONE NO : 703 952 0240   
8210-D CINDERBED RD.              SE DECISION MADE: 19-AUG-11
LORTON VA 22079                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTROTORQUE TLC
KALTENBACH & VOIGT GMBH           510(k) NO: K103027(TRADITIONAL)
ATTN: CLAUDIA  ORTIZ              PHONE NO : 714 516 7981   
1717 WEST COLLINS                 SE DECISION MADE: 19-AUG-11
ORANGE CA 92687                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROFEMUR(R) E CEMENTLESS HIP STEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K111698(SPECIAL)
ATTN: GREGORY  NEAL               PHONE NO : 901 290 5812   
5677 AIRLINE RD.                  SE DECISION MADE: 19-AUG-11
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K111699(SPECIAL)
ATTN: GREGORY  NEAL               PHONE NO : 901 290 5812   
5677 AIRLINE RD.                  SE DECISION MADE: 19-AUG-11
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM)
SONOMA ORTHOPEDIC PRODUCTS, INC.  510(k) NO: K111550(TRADITIONAL)
ATTN: CHARLES L NELSON            PHONE NO : 707 526 1335   
3589 WESTWIND BLVD                SE DECISION MADE: 19-AUG-11
SANTA ROSA CA 95403               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLARIS SPINAL SYSTEM
BIOMET SPINE (EBI LLC)            510(k) NO: K111957(TRADITIONAL)
ATTN: VIVIAN  KELLY, RAC          PHONE NO : 973 299 9300   
100 INTERPACE PARKWAY             SE DECISION MADE: 19-AUG-11
PARSIPPANY NJ 07540               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LCCS INSULATED SPINAL NEEDLE (RF CANNULA)
LCCS PRODUCTS LIMITED             510(k) NO: K112231(TRADITIONAL)
ATTN: FIELD  FU                   PHONE NO : 860 755 86069197
05C FUJAI KANGLE BUILDING NANSHAN SE DECISION MADE: 19-AUG-11
SHENZHEN, GUANGDONG    CH 518000  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE
CENTRAL MEDICARE SDN BHD          510(k) NO: K103734(TRADITIONAL)
ATTN: NICK  WANG                  PHONE NO : 909 860 1908   
1930 BREA CANYON ROAD, #240,DIAMONSE DECISION MADE: 19-AUG-11
DIAMOND BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E-CUBE
SAESHIN PRECISION CO., LTD.       510(k) NO: K111616(TRADITIONAL)
ATTN: Y S LEE                     PHONE NO : 82 53 5872345
#93-15, PAHO-DONG, DALSEO-GU      SE DECISION MADE: 19-AUG-11
DAEGU    KS 704-220               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EVOLVE (R) TRIAD (TM)  PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K111432(TRADITIONAL)
ATTN: ANGELA  SMITH               PHONE NO : 901 867 4184   
5677 AIRLINE RD.                  SE DECISION MADE: 19-AUG-11
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
HOLOGIC, INC.                     510(k) NO: K111508(TRADITIONAL)
ATTN: DEBORAH  THOMAS             PHONE NO : 781 999 7558   
35 CROSBY DR.                     SE DECISION MADE: 19-AUG-11
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
SPINEART                          510(k) NO: K112108(SPECIAL)
ATTN: FRANK P ENNESI              PHONE NO : 41 227 994025
COINTRIN 20 ROUTE DE PRE-BOIS CP18SE DECISION MADE: 19-AUG-11
GENEVA    SZ 1215                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: P200T
OPTOS PLC                         510(k) NO: K111628(SPECIAL)
ATTN: HOWARD M HOLSTEIN           PHONE NO : 202 637 5815   
555 THIRTEENTH STREET, NW         SE DECISION MADE: 19-AUG-11
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIMAX VERESS NEEDLE
UNIMAX MEDICAL SYSTEMS, INC.      510(k) NO: K111441(TRADITIONAL)
ATTN: MICHAEL  LEE                PHONE NO : 886 2 28096995
NO. 45, MINSHEN RD. DANSHUI TOWN  SE DECISION MADE: 19-AUG-11
TAIPEI COUNTY    TW 251           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUGAIT(TM) SUBTALAR IMPLANT SYSTEM
ASCENSION ORTHOPEDIC              510(k) NO: K111799(TRADITIONAL)
ATTN: BRADLEY W STRASSER          PHONE NO : 512 836 5001   
8700 CAMERON RD., STE. 100        SE DECISION MADE: 19-AUG-11
Austin TX 78754                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAVIOS CALCIUM HYDROXIDE CAVITY LINER
NEODENTAL CHEMICAL PRODUCTS CO., L510(k) NO: K111668(TRADITIONAL)
ATTN: ROBERT  SEIPLE              PHONE NO : 512 327 9997   
611 WEST 5TH STREET               SE DECISION MADE: 19-AUG-11
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INBODY
BIOSPACE CORPORATION LIMITED      510(k) NO: K110689(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 19-AUG-11
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITALA CONTINENCE CONTROL DEVICE
CONVATEC INC.                     510(k) NO: K111365(TRADITIONAL)
ATTN: MARK R JAKUBOWSKI           PHONE NO : 908 904 2719   
200 HEADQUARTERS PARK DR.         SE DECISION MADE: 19-AUG-11
SKILLMAN NJ 08558                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROCATHETER
NAVILYST MEDICAL, INC.            510(k) NO: K112124(ABBREVIATED)
ATTN: WANDA  CARPINELLA           PHONE NO : 508 658 7929   
26 FOREST STREET                  SE DECISION MADE: 19-AUG-11
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
BECKMAN COULTER, INC.             510(k) NO: K111952(ABBREVIATED)
ATTN: KERRIE S OETTER             PHONE NO : 952 368 7585   
1000 LAKE HAZELTINE DR. MS R-275-BSE DECISION MADE: 19-AUG-11
CHASKA MN 55318 1084              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIPOSONIX SYSTEM, MODEL 1 P00XXXX
MEDICIS TECHNOLOGIES CORPORATION  510(k) NO: K100874(TRADITIONAL)
ATTN: JONATHAN  KAHAN             PHONE NO : 202 637 5600   
COLUMBIA SQUARE 555 13TH STREET NWSE DECISION MADE: 19-AUG-11
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX SCAPHOLUNATE ANCHOR
ARTHREX, INC.                     510(k) NO: K111661(SPECIAL)
ATTN: COURTNEY  SMITH             PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 19-AUG-11
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE
ASAHI INTECC CO., LTD.            510(k) NO: K110584(TRADITIONAL)
ATTN: YOSHI  TERAI                PHONE NO : 949 756 8252   
2500 RED HILL SUITE 210           SE DECISION MADE: 22-AUG-11
SANTA ANA CA 92705                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: YOLO CURVE
YOLO MEDICAL INC.                 510(k) NO: K110342(TRADITIONAL)
ATTN: ROBERT J KRZNARIC           PHONE NO : 604 542 2200
#245 - 1959   152ND STREET        SE DECISION MADE: 22-AUG-11
SURREY, BRITISH COLUMBIA    CA V4A510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RELIEVA SOLO ELITE SINUS BALLOON CATHETER
ACCLARENT, INC.                   510(k) NO: K111254(TRADITIONAL)
ATTN: KIM  KY                     PHONE NO : 650 687 4473   
1525-B O'BRIEN DR.                SE DECISION MADE: 22-AUG-11
MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BOSTON BAND
BOSTON BRACE INTL., INC.          510(k) NO: K111609(TRADITIONAL)
ATTN: JAMES  WYNNE                PHONE NO : 800 262 2235   
20 LEDIN DR.                      SE DECISION MADE: 22-AUG-11
AVON MA 02322                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TALON DISTALFIX PROXIMAL FEMORAL NAIL
ORTHOPEDIC DESIGNS NORTH AMERICA, 510(k) NO: K111352(ABBREVIATED)
ATTN: SETH  MASEK                 PHONE NO : 813 443 4905   
5912 BRECKENRIDGE PARKWAY SUITE F SE DECISION MADE: 22-AUG-11
TAMPA FL 33610                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEKA TAC DEVICE
DEKA RESEARCH & DEVELOPMENT CORP. 510(k) NO: K093915(TRADITIONAL)
ATTN: ROBERT  SWAIN               PHONE NO : 603 669 5139   
340 COMMERCIAL ST.                SE DECISION MADE: 23-AUG-11
MANCHESTER NH 03101 1108          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DDRELEMENT
SWISSRAY MEDICAL AG               510(k) NO: K110828(TRADITIONAL)
ATTN: JOHN  MONAHAN               PHONE NO : 908 372 6412   
ONE TOWER CENTER                  SE DECISION MADE: 23-AUG-11
EAST BRUNSWICK NJ 07201           510(k) STATEMENT

DEVICE: BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL
BIO-RAD LABORATORIES              510(k) NO: K111072(SPECIAL)
ATTN: JUANG  WANG                 PHONE NO : 510 741 4609   
5500 E. 2ND STREET                SE DECISION MADE: 23-AUG-11
BENICIA CA 94510                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESPIRE BLUE SERIES
RESPIRE MEDICAL                   510(k) NO: K111207(ABBREVIATED)
ATTN: DANIELA  LEVY               PHONE NO : 213 447 5297   
22817 VENTURA BLVD #161           SE DECISION MADE: 23-AUG-11
WOODLAND HILLS CA 91364           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
RONGYAO PLASTIC PRODUCE CO., LTD  510(k) NO: K110016(TRADITIONAL)
ATTN: ZHAO  GANG                  PHONE NO : 863 182 126583
#58 BINHU ROAD                    SE DECISION MADE: 23-AUG-11
HENGSHUICITY    CH 053000         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRA(TM) CUSA NXT(TM) BONE TIPS
INTEGRA BURLINGTON MA, INC. (FORME510(k) NO: K111741(TRADITIONAL)
ATTN: KEVIN J O'CONNELL           PHONE NO : 781 565 1227   
22 Terry Ave                      SE DECISION MADE: 23-AUG-11
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS
SKELETAL DYNAMICS, LLC            510(k) NO: K111620(TRADITIONAL)
ATTN: ANA M ESCAGEDO              PHONE NO : 305 596 7585   
8905 SW 87 AVENUE, SUITE 201      SE DECISION MADE: 23-AUG-11
MIAMI FL 33176                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
CENTERS FOR DISEASE CONTROL AND PR510(k) NO: K111507(TRADITIONAL)
ATTN: CAPT HYE-JOO  KIM, PHARM.D. PHONE NO : 404 639 4643   
1600 CLIFTON RD. MS-C12           SE DECISION MADE: 23-AUG-11
ATLANTA GA 30333                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG
DERMA CARE PLUS PRODUCTS, LLC     510(k) NO: K111589(TRADITIONAL)
ATTN: JOSEPH  NEUSER              PHONE NO : 920 469 4514   
2614 MAIN STREET                  SE DECISION MADE: 23-AUG-11
GREEN BAY WI 54311                510(k) STATEMENT

DEVICE: PASS ANTERIOR SPINAL SYSTEM
MEDICREA TECHNOLOGIES             510(k) NO: K102406(TRADITIONAL)
ATTN: J D WEBB                    PHONE NO : 512 388 0199
1001 OAKWOOD BLVD.                SE DECISION MADE: 23-AUG-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STREAMLINE TL SPINAL SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC  510(k) NO: K111502(TRADITIONAL)
ATTN: SARAH  MCINTYRE             PHONE NO : 906 225 5861   
375 RIVER PARK CIRCLE             SE DECISION MADE: 23-AUG-11
Marquette MI 49855                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE
CIRCLE CARDIOVASCULAR IMAGING INC.510(k) NO: K111373(TRADITIONAL)
ATTN: SHIRANTHA  SAMARAPPULI      PHONE NO : 403 338 1870
#12, 3535 RESEARCH ROAD NW        SE DECISION MADE: 23-AUG-11
CALGARY, AB    CA T2L 2K8         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR
APPLIED CARDIAC SYSTEMS, INC.     510(k) NO: K103706(ABBREVIATED)
ATTN: R. BEN  GHADIMI             PHONE NO : 949 855 9366   
22912 EL PACIFICO DRIVE           SE DECISION MADE: 24-AUG-11
LAGUNA HILLS CA 92653             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFECARE CONDUCTIVE GARMENTS
EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K103719(ABBREVIATED)
ATTN: JAY  MANSOUR                PHONE NO : 678 908 8180   
845 ARONSON LAKE COURT            SE DECISION MADE: 24-AUG-11
ROSWELL GA 30075                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
INSTRUMENTATION LABORATORY CO.    510(k) NO: K110031(TRADITIONAL)
ATTN: JACQUELINE  EMERY           PHONE NO : 781 861 4350   
180 HARTWELL ROAD                 SE DECISION MADE: 24-AUG-11
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT
C.R. BARD, INC.                   510(k) NO: K102511(TRADITIONAL)
ATTN: JONI  CREAL                 PHONE NO : 480 638 2906   
1625 WEST 3RD ST.                 SE DECISION MADE: 24-AUG-11
TEMPE AZ 85281 1740               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL THERMOMETER MT SERIES
SEJOY ELECTRONICS & INSTRUMENTS CO510(k) NO: K110776(SPECIAL)
ATTN: YUNHUA  REN                 PHONE NO : 865 718 1957767
WEST LAKE ECONOMY & TECHNOLOGY ZONSE DECISION MADE: 24-AUG-11
HANGZHOU, ZHEJIANG    CH 310030   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM
SOUNDCURE INC                     510(k) NO: K111293(TRADITIONAL)
ATTN: NANCY  LINCE                PHONE NO : 650 759 6186   
560 SOUTH WINCHESTER BLVD SUITE 50SE DECISION MADE: 24-AUG-11
SAN JOSE CA 95128                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHENGKUN CHEMICAL
ZIBO SHENGKUN CHEMICAL INDUSTRIAL 510(k) NO: K110621(TRADITIONAL)
ATTN: JASON  LIU                  PHONE NO : 865 337 524868
FINE CHEMICAL PARK, CHEMICAL INDUSSE DECISION MADE: 24-AUG-11
ZIBO, SHANDONG    CH 255400       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERIMETER INTERBODY FUSION DEVICE
MEDTRONIC SOFAMOR DANEK           510(k) NO: K111525(SPECIAL)
ATTN: MIKE  SCOTT                 PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 24-AUG-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHESAPEAKE (CERVICAL COMPONENTS)
K2M, INC.                         510(k) NO: K111439(TRADITIONAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR.,SE                 SE DECISION MADE: 24-AUG-11
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOGEL ORTHOPOR BROWN SURGICAL GLOVE
MOLNLYCKE HEALTHCARE, US LLC      510(k) NO: K112089(SPECIAL)
ATTN: ANGELA L BUNN, RAC          PHONE NO : 678 250 7930   
5550 PEACHTREE PARKWAY SUITE 500  SE DECISION MADE: 24-AUG-11
NORCROSS GA 30092                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECG SERIES ELECTROCARDIOGRAPH
ADVANCED INSTRUMENTATIONS, INC.   510(k) NO: K111805(TRADITIONAL)
ATTN: JORGE  MILLAN               PHONE NO : 305 925 1260   
601 W 20 ST                       SE DECISION MADE: 24-AUG-11
HIALEAH FL 33010                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUVANT, MOBILE CARDIAC TELEMETRY
CORVENTIS, INC.                   510(k) NO: K111917(ABBREVIATED)
ATTN: MICHELE  CHIN-PURCELL       PHONE NO : 651 925 3803   
1410 ENERGY PARK DRIVE, SUITE 1   SE DECISION MADE: 24-AUG-11
ST. PAUL MN 55108                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES
PIONEER SURGICAL TECHNOLOGY, INC  510(k) NO: K111528(SPECIAL)
ATTN: SARAH  MCINTYRE             PHONE NO : 906 225 5861   
375 RIVER PARK CIRCLE             SE DECISION MADE: 24-AUG-11
Marquette MI 49855                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VESOFLOW
CAREMED SUPPLY, INC.              510(k) NO: K110977(TRADITIONAL)
ATTN: EDWARD A KROLL              PHONE NO : 440 546 9810   
5905 FAWN LANE                    SE DECISION MADE: 25-AUG-11
CLEVELAND OH 44141                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DAYTONA ANTERIOR CERVICAL CAGE
SPINENET, LLC                     510(k) NO: K110733(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 25-AUG-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GEMORE MUSCLE CONDITIONER;
GEMORE TECHNOLOGY CO., LTD.       510(k) NO: K102926(TRADITIONAL)
ATTN: BODEN  LAI                  PHONE NO : 886 288 091799
11 FL, NO. 29-5, SEC. 2 CHUNG CHENSE DECISION MADE: 25-AUG-11
TAN SHUI, TAIPEI HSIEN    TW 251  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K110934(TRADITIONAL)
ATTN: SANDRA D WHITE              PHONE NO : 508 660 4553   
333 CONEY STREET                  SE DECISION MADE: 25-AUG-11
WALPOLE MA 02032 1516             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS N-MID OSTEOCALCIN CALCHECK 5
ROCHE DIAGNOSTICS                 510(k) NO: K112104(TRADITIONAL)
ATTN: JANE E PHILLIPS             PHONE NO : 317 521 3338   
9115 HAGUE ROAD                   SE DECISION MADE: 25-AUG-11
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS
SENTINEL MEDICAL, INC.            510(k) NO: K112112(SPECIAL)
ATTN: JOAN  MEDLEY                PHONE NO : 647 258 3607
555 RICHMOND STREET WEST SUITE 800SE DECISION MADE: 25-AUG-11
TORONTO    CA M5V 3B1             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONICATOR PLUS 920
METTLER ELECTRONICS CORP.         510(k) NO: K111482(SPECIAL)
ATTN: CHRISTINA  CAYUELA          PHONE NO : 714 533 2221   
1333 SOUTH CLAUDINA ST.           SE DECISION MADE: 25-AUG-11
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: YOULASER CO2 LASER SYSTEM
QUANTA SYSTEM, S.P.A.             510(k) NO: K111592(TRADITIONAL)
ATTN: MAURIZIO  BIANCHI           PHONE NO : 39 033 1376797
VIA IV NOVEMBRE,116               SE DECISION MADE: 25-AUG-11
SOLBIATE OLONA(VA)    IT 21058    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: XYLOS MACRO-POROUS SURGICAL MESH
XYLOS CORPORATION                 510(k) NO: K111584(TRADITIONAL)
ATTN: GONZALO C SERAFICA          PHONE NO : 215 867 0220   
838 TOWN CENTER DR.               SE DECISION MADE: 25-AUG-11
LANGHORNE PA 19047                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUILION LB MOVEMENT BASE KIT
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K111633(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DR                  SE DECISION MADE: 25-AUG-11
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY
VENTANA MEDICAL SYSTEMS, INC.     510(k) NO: K101234(TRADITIONAL)
ATTN: JUDY  HOWE                  PHONE NO : 520 229 3829   
1910 EAST INNOVATION PARK DR.     SE DECISION MADE: 25-AUG-11
TUCSON AZ 85755                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET
NORFOLK MEDICAL                   510(k) NO: K111101(TRADITIONAL)
ATTN: MICHAEL J DALTON            PHONE NO : 847 674 7075   
7350 N. RIDGEWAY                  SE DECISION MADE: 25-AUG-11
SKOKIE IL 60076                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOWRIST ONE SUCTION/IRRIGATOR
INTUITIVE SURGICAL, INC.          510(k) NO: K110451(TRADITIONAL)
ATTN: BRANDON  HANSEN             PHONE NO : 408 523 2100   
1266 KIFER ROAD                   SE DECISION MADE: 26-AUG-11
SUNNYVALE CA 94086                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSTINCT JAVA SYSTEM
ZIMMER SPINE                      510(k) NO: K111301(TRADITIONAL)
ATTN: ELSA A LINKE                PHONE NO : 952 830 6205   
7375 BUSH LAKE ROAD               SE DECISION MADE: 26-AUG-11
EDINA MN 55439                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL
WELL LEAD MEDICAL CO. LTD         510(k) NO: K110269(TRADITIONAL)
ATTN: JOHN  OBRIEN                PHONE NO : 813 645 2855   
962 ALLEGRO LANE                  SE DECISION MADE: 26-AUG-11
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COVAMAX RESORBABLE COLLAGEN MEMBRANE
BIOM'UP SAS                       510(k) NO: K103087(TRADITIONAL)
ATTN: VALERIE  CENTIS             PHONE NO : 330 486 573610
8, ALLEE IRENE JOLIOT-CURIE       SE DECISION MADE: 26-AUG-11
ST-PRIEST    FR 69800             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
ANDON MEDICAL CO., LTD.           510(k) NO: K102678(TRADITIONAL)
ATTN: YI  LIU                     PHONE NO : 862 287 612426
NO. 04-23-3 AIRPORT INDUSTRIAL PARSE DECISION MADE: 26-AUG-11
TIANJIN    CH 300381              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONOBLOC BM SERIES
HASS CORP.                        510(k) NO: K111573(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 869 3080   
951 STARBUCK ST. UNIT J           SE DECISION MADE: 26-AUG-11
FULLERTON CA 92833                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
AIRSTRIP TECHNOLOGIES, LP         510(k) NO: K112235(TRADITIONAL)
ATTN: ANDY  MILLER                PHONE NO : 210 363 8753   
3303 OAKWELL CT., SUITE 200       SE DECISION MADE: 26-AUG-11
SAN ANTONIO TX 78218              510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
GENORAY CO., LTD.                 510(k) NO: K103181(TRADITIONAL)
ATTN: JAE  KIM                    PHONE NO : 714 289 8020   
1073 N, BATAVIA ST                SE DECISION MADE: 26-AUG-11
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER
EXACT MEDICAL MANUFACTURING, INC  510(k) NO: K111535(TRADITIONAL)
ATTN: ROBERT O DEAN               PHONE NO : 716 440 7362   
1083 DELAWARE AVE                 SE DECISION MADE: 26-AUG-11
BUFFALO NY 14209                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANGIOSCULPT PTA SCORING BALLOON CATHETER
ANGIOSCORE, INC.                  510(k) NO: K112182(SPECIAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202 637 5794   
555 THIRTEENTH STREET NW          SE DECISION MADE: 26-AUG-11
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMFORTGLIDE INTERMITENT CATHETER
C.R. BARD, INC.                   510(k) NO: K112137(TRADITIONAL)
ATTN: STACCI  CRONK               PHONE NO : 770 784 6994   
8195 INDUSTRIAL BLVD.             SE DECISION MADE: 26-AUG-11
COVINGTON GA 30014                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: AUTOREADER 2
TREK DIAGNOSTIC SYSTEMS           510(k) NO: K103532(TRADITIONAL)
ATTN: CYNTHIA  KNAPP              PHONE NO : 216 351 8735   
982 KEYNOTE CIRCLE                SE DECISION MADE: 26-AUG-11
CLEVELAND OH 44131                510(k) STATEMENT

DEVICE: HARMONIE SYSTEM
STELLATE SYSTEMS                  510(k) NO: K083577(ABBREVIATED)
ATTN: GOLDY  SINGH                PHONE NO : 905 829 5300
376 VICTORIA AVENUE, SUITE 200    SE DECISION MADE: 29-AUG-11
MONTREAL, QUEBEC    CA H3Z 1C3    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020
ABBOTT MOLECULAR, INC.            510(k) NO: K091960(TRADITIONAL)
ATTN: PAMELA L SWATKOWSKI         PHONE NO : 224 361 7013   
1300 EAST TOUHY AVENUE            SE DECISION MADE: 29-AUG-11
DES PLAINES IL 60018              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INQU PASTE MIX PLUS
ISTO TECHNOLOGIES, INC.           510(k) NO: K103799(TRADITIONAL)
ATTN: PATSY J TRISLER, JD, RAC    PHONE NO : 301 652 6344   
5600 WISCONSIN AVE. #509          SE DECISION MADE: 29-AUG-11
CHEVY CHASE MD 20815              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES
DAAVLIN DISTRIBUTING CO.          510(k) NO: K111172(TRADITIONAL)
ATTN: MICHELE  THIEL              PHONE NO : 419 636 6304   
205 WEST BEMENT ST.               SE DECISION MADE: 29-AUG-11
BRYAN OH 43506                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLUEPHASE STYLE
IVOCLAR VIVADENT, INC.            510(k) NO: K110756(TRADITIONAL)
ATTN: DONNA MARIE  HARTNETT       PHONE NO : 716 691 2260   
175 PINEVIEW DR.                  SE DECISION MADE: 29-AUG-11
AMHERST NY 14228                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
NOVA BIOMEDICAL CORPORATION       510(k) NO: K110648(SPECIAL)
ATTN: PAUL W MACDONALD            PHONE NO : 781 894 0800   
200 PROSPECT ST.                  SE DECISION MADE: 29-AUG-11
WALTHAM MA 02453                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K103308(SPECIAL)
ATTN: CRYSTAL  DIZOL HAGAN        PHONE NO : 424 218 8381   
2151 E. GRAND AVE.                SE DECISION MADE: 29-AUG-11
EL SEGUNDO CA 90245               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SLIC SCREW REPAIR SYSTEM
ACUMED LLC                        510(k) NO: K111608(SPECIAL)
ATTN: HOLLACE  RHODES             PHONE NO : 202 552 5800   
1331 H STREET NW 12TH FLOOR       SE DECISION MADE: 29-AUG-11
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MATRISTEM WOUND MATRIX
ACELL, INC                        510(k) NO: K112409(SPECIAL)
ATTN: DEBORAH A BAKER-JANIS       PHONE NO : 410 715 1700   
6640 ELI WHITNEY DRIVE SUITE 200  SE DECISION MADE: 29-AUG-11
COLUMBIA MD 21046                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL
SERF                              510(k) NO: K111572(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD.                SE DECISION MADE: 29-AUG-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
SMITHS MEDICAL MD, INC.           510(k) NO: K111386(TRADITIONAL)
ATTN: JAMES  CHAPMAN              PHONE NO : 651 628 7611   
1265 GREY FOX RD.                 SE DECISION MADE: 29-AUG-11
ST. PAUL MN 55112                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONO-SERIES CORNERSTONE TECHNIQUE
PAJUNK GMBH MEDIZINTECHNOLOGIE    510(k) NO: K111374(TRADITIONAL)
ATTN: CHRISTIAN  QUASS            PHONE NO : 497 704 9291
KARL-HALL-STRASSE 01              SE DECISION MADE: 29-AUG-11
GEISINGEN, BADEN-WURTTEMBERG    GM510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM
SAMSUNG MEDISON CO., LTD          510(k) NO: K112339(TRADITIONAL)
ATTN: KYEONG-MI  PARK             PHONE NO : 822 219 41373
1003 DAECHI-DONG, GANGNAM-GU      SE DECISION MADE: 29-AUG-11
SEOUL    KS 135-280               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SNAP WOUND CARE SYSTEM
SPIRACUR, INC.                    510(k) NO: K112341(SPECIAL)
ATTN: SARAH  CANIO                PHONE NO : 408 400 0856   
755 N. MATHILDA AVENUE            SE DECISION MADE: 29-AUG-11
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION
RIGHTMEDICAL PRODUCTS, LLC        510(k) NO: K110129(TRADITIONAL)
ATTN: MELANIE  DESLAURIERS        PHONE NO : 416 615 0185
1430 BIRCHMOUNT ROAD              SE DECISION MADE: 30-AUG-11
TORONTO, ONTARIO    CA M1P 2E8    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE
XIAN FRIENDSHIP MEDICAL ELECTRONIC510(k) NO: K110289(TRADITIONAL)
ATTN: ZHAI YING  CHUAN            PHONE NO : 862 988 225200
NO 9, GAO ZIN 1ST ROAD HI-TECH DEVSE DECISION MADE: 30-AUG-11
XI'AN, SHAANXI    CH 710075       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZYTO HAND CRADLE
ZYTO TECHNOLOGIES, INC            510(k) NO: K111308(TRADITIONAL)
ATTN: VAUGHN R COOK               PHONE NO : 801 224 7199   
387 SOUTH 520 WEST SUITE 200      SE DECISION MADE: 30-AUG-11
LINDON UT 84042                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K111548(TRADITIONAL)
ATTN: KATHERINE Y CHOI            PHONE NO : 203 602 3568   
419 WEST AVE.                     SE DECISION MADE: 30-AUG-11
STAMFORD CT 06902 6300            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEPUY STTUNE (TM) PS KNEE SYSTEM
DEPUY ORTHOPAEDICS, INC.          510(k) NO: K111433(TRADITIONAL)
ATTN: NANCY  FRIDDLE              PHONE NO : 574 371 4923   
700 ORTHOPAEDIC DRIVE             SE DECISION MADE: 30-AUG-11
WARSAW IN 46581 0988              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05
ELITECHGROUP                      510(k) NO: K112029(ABBREVIATED)
ATTN: DEBRA K HUTSON              PHONE NO : 425 482 5174   
21720 23RD DR SE SUITE 150        SE DECISION MADE: 30-AUG-11
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200
TYSON BIORESEARCH, INC.           510(k) NO: K101543(SPECIAL)
ATTN: WEN-HAI  TSAI               PHONE NO : 886 37 585988
5F, #22, KE E. ROAD, III SCIENCE-BSE DECISION MADE: 30-AUG-11
CHUN-NAN, MIAO-LI COUNTY    TW 350510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PALINDROME RT CHRONIC CATHETER
COVIDIEN                          510(k) NO: K111817(SPECIAL)
ATTN: WING  NG                    PHONE NO : 508 261 6596   
15 HAMPSHIRE STREET               SE DECISION MADE: 30-AUG-11
MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONICA IF24
MONICA HEALTHCARE                 510(k) NO: K112163(TRADITIONAL)
ATTN: IAN  HOW                    PHONE NO : 44 011 59124541
PENNYFOOT STREET                  SE DECISION MADE: 30-AUG-11
NOTTINGHAM    UK NG1 1GF          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4" (45MM) AND 18GA X 1-1/4" (32MM) / 20GA X 1-1/4" (32MM) / 20GA X 1
B. BRAUN MELSUNGEN AG             510(k) NO: K111236(TRADITIONAL)
ATTN: ANGELA J CARAVELLA          PHONE NO : 610 596 2966   
901 MARCON BLVD                   SE DECISION MADE: 30-AUG-11
ALLENTOWN PA 18109                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TSRH SPINAL SYSTEMS
MEDTRONIC SOFAMOR DANEK USA, INC  510(k) NO: K111942(SPECIAL)
ATTN: LILA  JOE                   PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 30-AUG-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TD-4239 BLOOD GLUCOSE MONITORING SYSTEM  AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K101635(TRADITIONAL)
ATTN: TELING  HSU                 PHONE NO : 886 266 258188
3F,5F, NO.127 WUGONG 2ND RD, WUGU SE DECISION MADE: 31-AUG-11
TAIPEI COUNTY    TW 24888         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION
APEX BIOTECHNOLOGY CORP.          510(k) NO: K101204(TRADITIONAL)
ATTN: HSUE-MEI  LEE               PHONE NO : 886 356 41952
NO. 7, LI-HSIN ROAD V, HSINCHU SCISE DECISION MADE: 31-AUG-11
HSINCHU    TW 30078               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CMC CABLE FIX
INSTRATEK, INC.                   510(k) NO: K111032(TRADITIONAL)
ATTN: JEFF  SEAVEY                PHONE NO : 281 890 9020   
4141 DIRECTORS ROW SUITE H        SE DECISION MADE: 31-AUG-11
HOUSTON TX 77092                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS
ELITECHGROUP SEPPIM S.A.S.        510(k) NO: K103747(TRADITIONAL)
ATTN: DEBRA K  HUTSON             PHONE NO : 425 482 5174   
21720 23RD DR SE, SUITE 150       SE DECISION MADE: 31-AUG-11
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MORPHEUS OX
DEGANIT BARAK-SHINAR              510(k) NO: K111314(TRADITIONAL)
ATTN: JOHN  SMITH                 PHONE NO : 202 637 5600   
555 THIRTEENTH STREET, NW         SE DECISION MADE: 31-AUG-11
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPSURE(R) PS SYSTEM
SPINE WAVE, INC.                  510(k) NO: K111913(SPECIAL)
ATTN: ROAIDA  RIZKALLAH           PHONE NO : 203 944 9494   
THREE ENTERPRISE DR SUITE 210     SE DECISION MADE: 31-AUG-11
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STEERABLE GUIDE CATHETER
ABBOTT VASCULAR                   510(k) NO: K112239(SPECIAL)
ATTN: CYNTHIA  MORROW             PHONE NO : 650 833 1610   
4045 CAMPBELL AVE                 SE DECISION MADE: 31-AUG-11
MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
CIRCA SCIENTIFIC, LLC             510(k) NO: K112376(TRADITIONAL)
ATTN: FRED  PIAZZA                PHONE NO : 303 951 8767   
14 INVERNESS DRIVE EAST, SUITE H24SE DECISION MADE: 31-AUG-11
ENGLEWOOD CO 80112                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MDRIVE
EMBLA SYSTEMS                     510(k) NO: K111742(SPECIAL)
ATTN: ROBERT G SCHUEPPERT         PHONE NO : 303 962 1786   
9351 GRANT STREET SUITE 600       SE DECISION MADE: 31-AUG-11
THORNTON CO 80229                 510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   271                                     
                                                 TOTAL WITH SUMMARIES        257                                     
                                                 TOTAL WITH STATEMENTS        14