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510(k)s Final Decisions Rendered for September 2005 |
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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-SEP-2005 THROUGH 30-SEP-2005 DEVICE: LCR 3M COMPANY 510(k) NO: K052235(SPECIAL)
ATTN: KAREN O'MALLEY PHONE NO : 651-736-7326 3M CENTER, BLDG. 260-2B-17 SE DECISION MADE: 27-SEP-05 ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUANQIU HEATING LAMP A & A MEDICAL SUPPLIES INC 510(k) NO: K052063(TRADITIONAL)
ATTN: GEORGE SU PHONE NO : 310-229-5748 1800 CENTURY PARK E. SUITE 600 SE DECISION MADE: 30-SEP-05 LOS ANGELES, CA 90067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE SURGICAL MASK A.R. MEDICOM, INC. 510(k) NO: K051291(TRADITIONAL)
ATTN: LUC TREPANIER PHONE NO : 514 636 6262 1200 55TH AVE. SE DECISION MADE: 20-SEP-05 LACHINE, QUEBEC, CANADA H8T 3J8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX ABBOTT SPINE, INC. 510(k) NO: K052247(SPECIAL)
ATTN: NOAH BARTSCH PHONE NO : 512-533-1840 5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 14-SEP-05 AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM ABBOTT VASCULAR DEVICES 510(k) NO: K052454(TRADITIONAL)
ATTN: DEBBIE COGAN PHONE NO : 650-474-3263 400 SAGINAW DR. SE DECISION MADE: 14-SEP-05 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY ACCURAY INCORPORATED 510(k) NO: K052325(SPECIAL)
ATTN: ANNE SCHLAGENHAFT PHONE NO : 408-716-4628 1310 CHESAPEAKE TERRACE SE DECISION MADE: 14-SEP-05 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UROPASS URETERAL ACCESS SHEATH, MODEL 61224 ACMI CORPORATION 510(k) NO: K051593(TRADITIONAL)
ATTN: GRAHAM BAILLIE PHONE NO : 508-804-2738 136 TURNPIKE RD. SE DECISION MADE: 02-SEP-05 SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 ACUMEN MEDICAL, INC. 510(k) NO: K051515(SPECIAL)
ATTN: MARYBETH GAMBER PHONE NO : 774-249-5250 1400 TERRA BELLA BLVD. SE DECISION MADE: 01-SEP-05 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA MOUNTAIN VIEW, CA 94043 DEVICE: AXXESS BUTTERFLY ANCHOR ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K052418(SPECIAL)
ATTN: STEVE TAMSETT PHONE NO : 972-309-8144 6901 PRESTON RD. SE DECISION MADE: 26-SEP-05 PLANO, TX 75024 510(k) STATEMENT DEVICE: MODEL 2800 PFT FILTER AIR SAFETY LTD 510(k) NO: K051712(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 01-SEP-05 MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALCON MULTI-PURPOSE DISINFECTING SOLUTION ALCON RESEARCH, LTD. 510(k) NO: K050729(TRADITIONAL)
ATTN: KIM B KRACKE PHONE NO : 817-551-8338 6201 SOUTH FREEWAY R7-20 SE DECISION MADE: 14-SEP-05 FORT WORTH, TX 76134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALILIFE STAND UP POWERED WHEELCHAIR, HC-300 ALILIFE TECHNOLOGICAL CO., LTD. 510(k) NO: K052375(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829 NO. 58 FU-CHIUN STREET SE DECISION MADE: 09-SEP-05 HSIN CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINGLE AMPLIFIER FOR BOTOX ALLERGAN, INC. 510(k) NO: K051852(TRADITIONAL)
ATTN: SUSAN O'BRIEN PHONE NO : 714-246-4177 2525 DUPONT DR. SE DECISION MADE: 14-SEP-05 IRVINE, CA 92612 510(k) STATEMENT DEVICE: REPROCESSED PHACOEMUISIFICATION TIPS ALLIANCE MEDICAL, INC. 510(k) NO: K050518(TRADITIONAL)
ATTN: ELIZABETH RENKEN PHONE NO : 480-763-5300 10232 SOUTH 51 ST. SE DECISION MADE: 23-SEP-05 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCHUCO MIST AND SCHUCO DELUXE MIST ALLIED HEALTHCARE PRODUCTS, INC. 510(k) NO: K051260(TRADITIONAL)
ATTN: WAYNE KARCHER PHONE NO : 314-771-2400 1720 SUBLETTE AVE. SE DECISION MADE: 15-SEP-05 ST. LOUIS, MO 63110 510(k) STATEMENT DEVICE: NEURODRIVE SYSTEM ALPHA OMEGA LTD. 510(k) NO: K051830(TRADITIONAL)
ATTN: SHLOMO PUNDAK PHONE NO : 972 465 63327 HA'AVODA ST., P.O. BOX 810 SE DECISION MADE: 16-SEP-05 NAZARETH ILLIT, ISRAEL 17105 510(k) STATEMENT DEVICE: IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT AMERITEK RESEARCH LLC 510(k) NO: K050352(TRADITIONAL)
ATTN: KUD CHAIANG YEE PHONE NO : 425-742-2768 15205 3RD DR. SE SE DECISION MADE: 01-SEP-05 MILL CREEK, WA 98012 510(k) STATEMENT DEVICE: SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 ANALOGIC CORP. 510(k) NO: K052447(ABBREVIATED)
ATTN: DONALD SHERRATT PHONE NO : 978-977-3000 8 CENTENNIAL DR. SE DECISION MADE: 21-SEP-05 CENTENNIAL INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA PEABODY, MA 01960 THIRD PARTY REVIEW DEVICE: ANDROFLOW - RESPIRATORY RATE MONITOR ANDROMED, INC. 510(k) NO: K051779(ABBREVIATED)
ATTN: GEORGE PAPAGIANNIS PHONE NO : 514 336 0043 4610 CHEMIN DU BOIS-FRANC SE DECISION MADE: 30-SEP-05 SAINT LAURENT, QUEBEC, CANADA H4S 510(k) STATEMENT DEVICE: ANGIODYNAMICS, INC., MICRO ACCESS KITS ANGIODYNAMICS, INC. 510(k) NO: K051655(TRADITIONAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215 603 QUEENSBURY AVE. SE DECISION MADE: 12-SEP-05 QUEENSBURY, NY 12804 510(k) STATEMENT DEVICE: ANGIOSCULPT SCORING BALLOON CATHETER ANGIOSCORE, INC. 510(k) NO: K050629(TRADITIONAL)
ATTN: GARY GERSHONY PHONE NO : 925-408-7252 965 ATLANTIC AVE., SUITE 101 SE DECISION MADE: 02-SEP-05 ALAMEDA, CA 94501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEMINI SURGICAL CONTROL & DISPLAY SYSTEM APPLIED SURGICAL, LLC 510(k) NO: K051831(TRADITIONAL)
ATTN: DAVID A ALEXANDER PHONE NO : 205-259-2050 300 RIVERCHASE PARKWAY EAST SE DECISION MADE: 07-SEP-05 BIRMINGHAM, AL 35244 510(k) STATEMENT DEVICE: ARTHREX TENODESIS FAMILY ARTHREX, INC. 510(k) NO: K051726(TRADITIONAL)
ATTN: QNN WATERHOUSE PHONE NO : 239-643-5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 27-SEP-05 NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOW PROFILE PLATE AND SCREW SYSTEM ARTHREX, INC. 510(k) NO: K052614(SPECIAL)
ATTN: SALLY FOUST PHONE NO : 239-643-5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 28-SEP-05 NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAHI TORNUS SUPPORT CATHETER ASAHI INTECC CO., LTD. 510(k) NO: K051772(TRADITIONAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252 1301 DOVE STREET, SUITE #350 SE DECISION MADE: 26-SEP-05 NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIS EEG MONITOR, MODEL A-3000 ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K052362(SPECIAL)
ATTN: CHRISTINE VOZELLA PHONE NO : 617-557-7028 141 NEEDHAM ST. SE DECISION MADE: 09-SEP-05 NEWTON, MA 02464 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ADVANTA T-GRAFT ATRIUM MEDICAL CORP. 510(k) NO: K051332(TRADITIONAL)
ATTN: KAREN HALL PHONE NO : 603-880-1433 5 WENTWORTH DR. SE DECISION MADE: 29-SEP-05 HUDSON, NH 03051 510(k) STATEMENT DEVICE: ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101 AVENT AMERICA, INC. 510(k) NO: K052047(TRADITIONAL)
ATTN: RICHARD MORRONEY PHONE NO : 508-872-2878 1 SPEEN STREET SE DECISION MADE: 22-SEP-05 SUITE 160 510(k) SUMMARY AVAILABLE FROM FDA FRAMINGHAM, MA 01701 DEVICE: B-CARE POWDER FREE LATEX EXAMINATION GLOVES B-CARE INDUSTRIES CO., LTD. 510(k) NO: K051404(TRADITIONAL)
ATTN: RUJIRA PHANPHIPHAT PHONE NO : 660 745 595016 11 CHOTIWITAYAKUL 3 ROAD SE DECISION MADE: 27-SEP-05 HATYAI, SONGKHLA, THAILAND 90110 510(k) STATEMENT DEVICE: NIO 2MP-20" AND E-2620 S BARCOVIEW 510(k) NO: K052276(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 32 56 233459 35 PRESIDENT KENNEDYPARK SE DECISION MADE: 21-SEP-05 KORTRIJK, BELGIUM B-8500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLOR CORONIS 2MP-21 AND MFCD 2321 BARCOVIEW 510(k) NO: K052352(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 325 623 3459 35 PRESIDENT KENNEDYPARK SE DECISION MADE: 30-SEP-05 KORTRIJK, BELGIUM B-8500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORONIS 2MP-21" AND MFGD 2621 BARCOVIEW 510(k) NO: K052403(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : +32 562 33459 35 PRESIDENT KENNEDYPARK SE DECISION MADE: 15-SEP-05 KORTRIJK, BELGIUM B-8500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORONIS 3MP-21 AND MFGD 3621 BARCOVIEW 510(k) NO: K052429(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 325 623 3459 35 PRESIDENT KENNEDYPARK SE DECISION MADE: 15-SEP-05 KORTRIJK, BELGIUM B-8500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MFCD 1219, MFCD 1219 TS BARCOVIEW 510(k) NO: K052478(TRADITIONAL)
ATTN: LIEVEN DE WANDAL PHONE NO : 325 623 3459 35 PRESIDENT KENNEDYPARK SE DECISION MADE: 28-SEP-05 KORTRIJK, BELGIUM B-8500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-2320 PA S BARCOVIEW 510(k) NO: K052529(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 32 56 233459 35 PRESIDENT KENNEDYPARK SE DECISION MADE: 30-SEP-05 KORTRIJK, BELGIUM B-8500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENAFLO II VASCULAR GRAFT BARD PERIPHERAL VASCULAR, INC. 510(k) NO: K052282(SPECIAL)
ATTN: GLENN NORTON PHONE NO : 480-379-2836 1625 WEST 3RD ST. SE DECISION MADE: 20-SEP-05 P.O. BOX 1740 510(k) SUMMARY AVAILABLE FROM FDA TEMPE, AZ 85280 DEVICE: BD PEN NEEDLE BECTON DICKINSON & CO. 510(k) NO: K051899(TRADITIONAL)
ATTN: JOHN SCHALAGO PHONE NO : 201-847-5663 1 BECTON DR. SE DECISION MADE: 13-SEP-05 MC 300 510(k) SUMMARY AVAILABLE FROM FDA FRANKLIN LAKES, NJ 07417-1880 DEVICE: BD PROBE TEC URINE PRESERVATIVE TRANSPORT BECTON, DICKINSON & CO. 510(k) NO: K052224(SPECIAL)
ATTN: KATHRYN BABKA POWERS PHONE NO : 410-316-4260 7 LOVETON CIR. SE DECISION MADE: 12-SEP-05 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-1 BECTON, DICKINSON & CO. 510(k) NO: K052250(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 30-SEP-05 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHOGRAFT BICON, INC. 510(k) NO: K051091(TRADITIONAL)
ATTN: VINCENT J MORGAN PHONE NO : 617-390-4363 501 ARBORWAY SE DECISION MADE: 01-SEP-05 BOSTON, MA 02130 510(k) STATEMENT DEVICE: BIOBANDS BIOBANDS DISTRIBUTORS, INC. 510(k) NO: K051397(TRADITIONAL)
ATTN: JAMES H HARTTEN PHONE NO : 202-857-8983 1050 CONNECTICUT AVENUE NW SE DECISION MADE: 16-SEP-05 WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXIMUS 3.0 AND OS IMPLANTS BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K052419(SPECIAL)
ATTN: WINSTON GREER PHONE NO : 205-967-7880 ONE PERIMETER PARK SOUTH SE DECISION MADE: 20-SEP-05 SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA BIRMINGHAM, AL 35243 DEVICE: MBCP BIOMATLANTE 510(k) NO: K051885(TRADITIONAL)
ATTN: MYRIAM VINCENT PHONE NO : +33 228 020009 5, RUE EDOUARD BELIN SE DECISION MADE: 16-SEP-05 VIGNEUX DE BRETAGNE, FRANCE 44360 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 GRAM NEGATIVE TIGECYCLINE BIOMERIEUX, INC. 510(k) NO: K052311(TRADITIONAL)
ATTN: JOLYN TENLLADO PHONE NO : 314-731-8386 595 ANGLUM RD. SE DECISION MADE: 29-SEP-05 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-POLY (VITAMIN E) ACETABULAR LINERS BIOMET, INC. 510(k) NO: K050327(TRADITIONAL)
ATTN: TRACY BICKEL JOHNSON PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 27-SEP-05 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46582 DEVICE: RINGLOC BI-POLAR ACETABULAR COMPONENT BIOMET, INC. 510(k) NO: K051569(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 29-SEP-05 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COPELAND EAS HUMERAL RESURFACING HEADS BIOMET, INC. 510(k) NO: K051843(TRADITIONAL)
ATTN: TRACY BICKEL JOHNSON PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 29-SEP-05 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POROUS COATED DISCOVERY ELBOW BIOMET, INC. 510(k) NO: K051975(SPECIAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 06-SEP-05 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOMIMETIC SYNTHETIC BONE MATRIX BIOMIMETIC PHARMACEUTICALS INC. 510(k) NO: K051775(TRADITIONAL)
ATTN: SANDRA WILLIAMSON PHONE NO : 615-771-8546 389 A NICHOL MILL LANE SE DECISION MADE: 06-SEP-05 FRANKLIN, TN 37067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARTO RMT EP NAVIGATION SYSTEM BIOSENSE WEBSTER, INC. 510(k) NO: K042681(TRADITIONAL)
ATTN: DIANA THORSON PHONE NO : 909-839-8466 3333 DIAMOND CANYON RD. SE DECISION MADE: 29-SEP-05 DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REFSTAR RMT EXTERNAL REFERENCE PATCH BIOSENSE WEBSTER, INC. 510(k) NO: K042998(SPECIAL)
ATTN: MARK O'DONNELL PHONE NO : 909-839-8466 3333 DIAMOND CANYON RD. SE DECISION MADE: 29-SEP-05 DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER BIOSENSE WEBSTER, INC. 510(k) NO: K052083(TRADITIONAL)
ATTN: DIANA M THORSON PHONE NO : 909-839-8604 3333 DIAMOND CANYON RD. SE DECISION MADE: 29-SEP-05 DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIAGE BNP TEST, MODEL 98000XR BIOSITE INCORPORATED 510(k) NO: K051787(TRADITIONAL)
ATTN: JEFFREY DAHLEN PHONE NO : 858-597-4815 11030 ROSELLE ST. SE DECISION MADE: 22-SEP-05 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 BLEASE USA, INC. 510(k) NO: K051629(SPECIAL)
ATTN: ARTHUR J WARD PHONE NO : 813-645-2855 962 ALLEGRO LANE SE DECISION MADE: 23-SEP-05 APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM BLUE SKY BIO, LLC 510(k) NO: K051507(TRADITIONAL)
ATTN: ALBERT ZICKMANN PHONE NO : 718-376-0422 888 E BELVIDERE RD. SE DECISION MADE: 02-SEP-05 SUITE 212 510(k) SUMMARY AVAILABLE FROM FDA GRAYSLAKE, IL 60030 DEVICE: CERAMENT BONE VOID FILLER BONE SUPPORT AB 510(k) NO: K051951(TRADITIONAL)
ATTN: JEFFREY R SHIDEMAN PHONE NO : 952-835-4018 7307 GLOUCHESTER DRIVE SE DECISION MADE: 28-SEP-05 EDINA, MN 55435 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGER II ANGIOGRAPHIC CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K050863(TRADITIONAL)
ATTN: DIANE BRINZA PHONE NO : 763-694-3061 ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 02-SEP-05 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION BOSTON SCIENTIFIC CORP. 510(k) NO: K052302(SPECIAL)
ATTN: JENNIFER BOLTON PHONE NO : 763-494-1163 2 SCIMED PLACE SE DECISION MADE: 12-SEP-05 MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPLAN RT FIBERTRACKING BRAINLAB AG 510(k) NO: K052220(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680 AMMERTHALSTRASSE 8 SE DECISION MADE: 30-SEP-05 HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SITE-RITE 5 ULTRASOUND SYSTEM C.R. BARD, INC. 510(k) NO: K052517(TRADITIONAL)
ATTN: KIMBERLY GEISLER PHONE NO : 801-595-0700 5425 WEST AMELIA EARHART DR. SE DECISION MADE: 29-SEP-05 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 CALDYNE, INC. 510(k) NO: K051279(TRADITIONAL)
ATTN: TOM SHANKS PHONE NO : 951-506-2674 29201 VIA NORTE SE DECISION MADE: 07-SEP-05 TEMECULA, CA 92591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRONO SUPER PID CANE S.R.L. 510(k) NO: K052217(SPECIAL)
ATTN: CARLO MUSSO PHONE NO : 390 119 574872 VIA PAVIA, 105/I SE DECISION MADE: 13-SEP-05 RIVOLI-CASCINE VICA (TORINO), ITAL510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRONO GO. CANE S.R.L. 510(k) NO: K052219(SPECIAL)
ATTN: CARLO MUSSO PHONE NO : 390 119 574872 VIA PAVIA, 105/I SE DECISION MADE: 13-SEP-05 RIVOLI-CASCINE VICA (TORINO), ITAL510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISANTE OCT CARL ZEISS MEDITEC INC 510(k) NO: K051789(TRADITIONAL)
ATTN: JUDITH A BRIMACOMBE PHONE NO : 925-557-4616 5160 HACIENDA DR. SE DECISION MADE: 30-SEP-05 DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOC CARLETON LIFE SUPPORT SYSTEMS INC.510(k) NO: K051887(TRADITIONAL)
ATTN: GARY BYRD PHONE NO : 563-383-6299 2734 HICKORY GROVE RD. SE DECISION MADE: 27-SEP-05 DAVENPORT, IA 52804-1203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRITON/TRU-TRAC/TX TRACTION DEVICES CHATTANOOGA GROUP 510(k) NO: K051938(TRADITIONAL)
ATTN: CHERYL BAGWELL PHONE NO : 423-870-2281 4717 ADAMS RD. SE DECISION MADE: 21-SEP-05 P.O. BOX 489 510(k) STATEMENT HIXSON, TN 37343 DEVICE: SOLO-CARE AQUA ANTIMICROBIAL LENS CASE CIBA VISION CORPORATION 510(k) NO: K041820(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678-415-3897 11460 JOHNS CREEK PARKWAY SE DECISION MADE: 09-SEP-05 DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED CONCENTRIC RETRIEVER, MODEL 90039 CONCENTRIC MEDICAL, INC. 510(k) NO: K051838(SPECIAL)
ATTN: JEAN M CAILLOUETTE PHONE NO : 650-938-2100 1380 SHOREBIRD WAY SE DECISION MADE: 01-SEP-05 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR CONMED CORPORATION 510(k) NO: K052009(TRADITIONAL)
ATTN: PAMELA VETTER PHONE NO : 303-699-7600 14603 E. FREMONT AVE. SE DECISION MADE: 28-SEP-05 CENTENNIAL, CO 80112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGISIS STAPLE LINE REINFORCEMENT II COOK BIOTECH, INC. 510(k) NO: K051048(TRADITIONAL)
ATTN: MARK BLEYER PHONE NO : 765-497-3355 1425 INNOVATION PLACE SE DECISION MADE: 23-SEP-05 WEST LAFAYETTE, IN 47906 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 70 CR TECH, LTD. 510(k) NO: K051494(TRADITIONAL)
ATTN: LEONARD FRIER PHONE NO : 410-354-3300 914 WEST PATAPSCO AVENUE SE DECISION MADE: 21-SEP-05 BALTIMORE, MD 21230 510(k) STATEMENT DEVICE: VCS S3Y CYCLING AND HEALTH TECH. INDUSTRY 510(k) NO: K051130(TRADITIONAL)
ATTN: CHANG WAN LAN PHONE NO : 886 4 23501100 NO. 17, 37TH RD., SE DECISION MADE: 09-SEP-05 TAICHUNG INDUSTRY PARK 510(k) SUMMARY AVAILABLE FROM FDA TAICHUNG, CHINA (TAIWAN) 40768 DEVICE: AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM CYNOSURE, INC. 510(k) NO: K050382(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 14-SEP-05 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HILT FAMILY LASER: HILT I, HILT II, HILT III CYNOSURE, INC. 510(k) NO: K051537(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 26-SEP-05 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6 CYNOSURE, INC. 510(k) NO: K051922(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 14-SEP-05 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER D.B.I. AMERICA CORP. 510(k) NO: K051910(TRADITIONAL)
ATTN: UBIRACI R FERNANDES PHONE NO : 813-931-3590 2909 BUSCH LAKE BLVD. SE DECISION MADE: 02-SEP-05 TAMPA, FL 33614 510(k) STATEMENT DEVICE: STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TES DADE BEHRING, INC. 510(k) NO: K051650(TRADITIONAL)
ATTN: PAMELA A JURGA PHONE NO : 302-631-8891 GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 08-SEP-05 BLDG.500 M.S. 514; PO BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC10 DADE BEHRING, INC. 510(k) NO: K052015(TRADITIONAL)
ATTN: ANDREA M TASKER PHONE NO : 302-631-9454 P.O. BOX 6101 SE DECISION MADE: 12-SEP-05 GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, DADE BEHRING, INC. 510(k) NO: K052017(TRADITIONAL)
ATTN: ANDREA M TASKER PHONE NO : 302-631-9454 GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 01-SEP-05 BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA P.O. BOX 6101, NEWARK, DE 19714-6101 DEVICE: GE DATEX-OHMEDA ENGSTROM CARESTATION DATEX-OHMEDA, INC. 510(k) NO: K051895(SPECIAL)
ATTN: DAN KOSEDNAR PHONE NO : 608-221-1551 PO BOX 7550 SE DECISION MADE: 27-SEP-05 MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUSION CURING LIGHT DENTLIGHT INC. 510(k) NO: K052593(TRADITIONAL)
ATTN: RICHARD LIU PHONE NO : 972-889-8857 4404 BRECKINRIDGE BLVD. SE DECISION MADE: 28-SEP-05 DUITE 400 510(k) SUMMARY AVAILABLE FROM FDA RICHARDSON, TX 75082 THIRD PARTY REVIEW DEVICE: CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, M DENTSPLY INTL. 510(k) NO: K052334(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 221 WEST PHILADELPHIA STREET SE DECISION MADE: 02-SEP-05 YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RO DEPUY SPINE, INC. 510(k) NO: K052131(SPECIAL)
ATTN: LIZ LAVELLE PHONE NO : 508-828-2852 325 PARAMOUNT DR. SE DECISION MADE: 28-SEP-05 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE DEVON SAFETY PRODUCTS, INC. 510(k) NO: K052551(TRADITIONAL)
ATTN: BARRY L BERLER PHONE NO : 610-757-4102 1100 FIRST AVE., SUITE 100 SE DECISION MADE: 30-SEP-05 KING OF PRUSSIA, PA 19406 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH DIGITIMER LTD. 510(k) NO: K051357(TRADITIONAL)
ATTN: HARRY J BENEDICT PHONE NO : 954-713-8017 ONE EAST BROWARD BOULEVARD SE DECISION MADE: 20-SEP-05 SUITE 700 510(k) SUMMARY AVAILABLE FROM FDA FORT LAUDERDALE, FL 33301 DEVICE: VOLAR PLATE SYSTEM DVO EXTREMITY SOLUTIONS, LLC 510(k) NO: K052150(ABBREVIATED)
ATTN: DINA L WEISSMAN PHONE NO : 203-287-0485 P.O. BOX 205 SE DECISION MADE: 08-SEP-05 DERBY, CT 06418 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE NEEDLE CATCHER E.D.MEDICAL LTD. 510(k) NO: K051281(TRADITIONAL)
ATTN: BRIAN MCNICHOLL PHONE NO : 353 87 2392023 32 CRANMORE AVENUE LISBURN RD SE DECISION MADE: 08-SEP-05 BELFAST, UNITED KINGDOM BT96JH 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI DYNAFIX VISION FOOTPLATE SYSTEM EBI, L.P. 510(k) NO: K052239(TRADITIONAL)
ATTN: PETER ALLAN PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 21-SEP-05 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDWARDS PERIPHERAL DILATION CATHETER EDWARDS LIFESCIENCES, LLC. 510(k) NO: K052149(SPECIAL)
ATTN: KEVIN DRISKO PHONE NO : 949-250-2416 ONE EDWARDS WAY SE DECISION MADE: 02-SEP-05 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COGNITRACE EEMAGINE MEDICAL IMAGING SOLUTIONS510(k) NO: K051825(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 12-SEP-05 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONOCHROME LCD MONITOR, MODEL RADIFORCE G33 EIZO NANAO CORPORATION 510(k) NO: K052337(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : +81 762 742468 153 SHIMOKASHIWANO-CHO SE DECISION MADE: 08-SEP-05 MATTO-SHI 510(k) SUMMARY AVAILABLE FROM FDA ISHIKAWA-KEN, JAPAN 924-8566 DEVICE: COLOR LCD MONITOR, MODEL RADIOFORCE R31 & R31-C EIZO NANAO CORPORATION 510(k) NO: K052344(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627 42468 153 SHIMOKASHIWANO-CHO SE DECISION MADE: 14-SEP-05 MATTO-SHI 510(k) SUMMARY AVAILABLE FROM FDA ISHIKAWA-KEN, JAPAN 924-8566 DEVICE: COBRA SURGICAL SYSTEM ESTECH, INC. 510(k) NO: K051749(TRADITIONAL)
ATTN: CRAIG COOMBS PHONE NO : 510-337-0140 1193 SHERMAN STREET SE DECISION MADE: 13-SEP-05 ALAMEDA, CA 94501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VICRYL * MESH BAG ETHICON, INC. 510(k) NO: K051701(TRADITIONAL)
ATTN: JENNIFER PAINE PHONE NO : 908-218-3102 ROUTE 22 WEST SE DECISION MADE: 29-SEP-05 SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE EXACTECH, INC. 510(k) NO: K051556(SPECIAL)
ATTN: DIANA TAYLOR PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 06-SEP-05 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND M FLOW X-RAY CORP. 510(k) NO: K052422(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHEREN BLVD., SUITE 200 SE DECISION MADE: 27-SEP-05 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES GE HEALTHCARE 510(k) NO: K051873(TRADITIONAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685 86 PILGRIM ROAD SE DECISION MADE: 20-SEP-05 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES GE HEALTHCARE 510(k) NO: K052167(SPECIAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685 86 PILGRIM ROAD SE DECISION MADE: 08-SEP-05 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANTAGE SIM MD GE HEALTHCARE 510(k) NO: K052345(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894 3000 N. GRANDVIEW BLVD SE DECISION MADE: 14-SEP-05 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND IN GE HEALTHCARE 510(k) NO: K052412(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894 3000 N. GRANDVIEW BLVD SE DECISION MADE: 16-SEP-05 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA GE MEDICAL SYSTEMS 510(k) NO: K052434(SPECIAL)
ATTN: ELI WERNER PHONE NO : 972 485 63824 4 HAYOZMA ST. P.O. BOX 170 SE DECISION MADE: 27-SEP-05 TIRAT HACARMEL, ISRAEL 30200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEER MC GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K042782(TRADITIONAL)
ATTN: GRACE LEMIEUX PHONE NO : 262-293-1609 8200 WEST TOWER AVE. SE DECISION MADE: 02-SEP-05 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM GE MEDICAL SYSTEMS, LLC 510(k) NO: K052293(SPECIAL)
ATTN: LARRY A KROGER, PH.D. PHONE NO : 262-544-3894 P.O. BOX 414 SE DECISION MADE: 21-SEP-05 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE LOGIQ 7 ULTRASOUND BT05 GENERAL ELECTRIC CO. 510(k) NO: K052441(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 4855 WEST ELECTRIC AVENUE SE DECISION MADE: 21-SEP-05 PO BOX 414 510(k) SUMMARY AVAILABLE FROM FDA MILWAUKEE, WI 53219 DEVICE: MATRIX HOLTER SYSTEM, MODEL M12 GLOBAL INSTRUMENTATION, LLC 510(k) NO: K051730(ABBREVIATED)
ATTN: CRAIG SELLERS PHONE NO : 315-682-0272 8104 CAZENOVIA ROAD SE DECISION MADE: 26-SEP-05 MANLIUS, NY 13104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MO GUIDANT CORPORATION 510(k) NO: K052274(SPECIAL)
ATTN: M. LAURIE WONG PHONE NO : 408-845-2014 3200 LAKESIDE DR. SE DECISION MADE: 21-SEP-05 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MCCARTNEY ACCESS TUBE GYNETECH PTY. LTD. 510(k) NO: K051594(TRADITIONAL)
ATTN: DENNIS HAHN PHONE NO : 513-337-3134 4545 CREEK ROAD SE DECISION MADE: 02-SEP-05 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DORSAL NAIL PLATE, ANATOMICAL HAND INNOVATIONS, LLC. 510(k) NO: K052248(SPECIAL)
ATTN: ERNESTO HERNANDEZ PHONE NO : 305-270-6899 8905 SW 87TH AVENUE SE DECISION MADE: 14-SEP-05 SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA MIAMI, FL 33176 DEVICE: OSTEOPAL V HERAEUS KULZER GMBH 510(k) NO: K050085(ABBREVIATED)
ATTN: CHRISTIAN TUCHSCHERER PHONE NO : 49 608 1959278 GRUNER WEG 11 SE DECISION MADE: 14-SEP-05 HANAU, GERMANY D-63450 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HHF1 MAGNETIC RESONANCE IMAGING SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K052172(ABBREVIATED)
ATTN: DOUG THISTLETHWAITE PHONE NO : 330-425-1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 27-SEP-05 TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 HORIBA ABX 510(k) NO: K050448(TRADITIONAL)
ATTN: TIM LAWTON PHONE NO : 334 671 47320 PARC EUROMEDECINE SE DECISION MADE: 23-SEP-05 RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA MONTPELLIER, HERAULT, FRANCE 34184 DEVICE: I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EA I-FLOW CORP. 510(k) NO: K052117(SPECIAL)
ATTN: SHANE NOEHRE PHONE NO : 949-206-2700 20202 WINDROW DR. SE DECISION MADE: 09-SEP-05 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7 IMC-HEARTWAY, LLC 510(k) NO: K052008(ABBREVIATED)
ATTN: JOHN FRYMARK PHONE NO : 866-464-9779 6140 MID METRO DRIVE, SUITE 6 SE DECISION MADE: 16-SEP-05 FORT MYERS, FL 33912 510(k) STATEMENT DEVICE: 3I OSSEOTITE DENTAL IMPLANTS IMPLANT INNOVATIONS, INC. 510(k) NO: K051461(TRADITIONAL)
ATTN: JACQUEYL A HUGHES PHONE NO : 561-776-6819 4555 RIVERSIDE DR. SE DECISION MADE: 15-SEP-05 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRABECULAR METAL VERTEBRAL BODY REPLACEMENT IMPLEX CORP. 510(k) NO: K051978(SPECIAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 23-SEP-05 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ-JECT INDOLOR, LTD. 510(k) NO: K051667(TRADITIONAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116 291 HILLSIDE AVENUE SE DECISION MADE: 27-SEP-05 SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM INION LTD. 510(k) NO: K052444(SPECIAL)
ATTN: HANNA MARTTILA PHONE NO : 358 3 2306600 LAAKARINKATU 2 SE DECISION MADE: 20-SEP-05 TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000 INNOVATIVE NEUROTRONICS INC. 510(k) NO: K052329(SPECIAL)
ATTN: FAYYAZ MEMON PHONE NO : 301-280-5012 TWO BETHESDA METRO CENTER SE DECISION MADE: 21-SEP-05 SUTE 1200 510(k) SUMMARY AVAILABLE FROM FDA BETHESDA, MD 20814 DEVICE: INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR INOVO, INC. 510(k) NO: K051540(TRADITIONAL)
ATTN: KEVIN CONFOY PHONE NO : 239-643-6577 2975 S. HORSESHOE DRIVE SE DECISION MADE: 21-SEP-05 SUITE 600 510(k) SUMMARY AVAILABLE FROM FDA NAPLES, FL 34104 DEVICE: MANIPUSEAL INSITU SYSTEMS 510(k) NO: K051160(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 02-SEP-05 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAYFIELD INFINITY SKULL CLAMP INTEGRA LIFESCIENCES CORP. 510(k) NO: K051440(TRADITIONAL)
ATTN: DONNA R WALLACE PHONE NO : 609-936-2397 311 ENTERPRISE DRIVE SE DECISION MADE: 20-SEP-05 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONNEXUS, .5CC, MODEL 023000-005 ISOTIS ORTHOBIOLOGICS, INC 510(k) NO: K052098(SPECIAL)
ATTN: PAUL DONER PHONE NO : 949-855-7168 2 GOODYEAR, SUITE B SE DECISION MADE: 07-SEP-05 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUEPHASE 16I IVOCLAR VIVADENT, INC. 510(k) NO: K051782(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 20-SEP-05 AMHERST, NY 14228 510(k) STATEMENT DEVICE: YI XIN STERILE SYRINGE FOR SINGLE USE JIANGXI SANXIN (EVERSINCERE) MEDIC510(k) NO: K050999(TRADITIONAL)
ATTN: YUN YUAN GAO PHONE NO : 867 915 101888 SHANJIANG ROAD SE DECISION MADE: 02-SEP-05 NANCHANG, JIANGXI, CHINA 330204 510(k) STATEMENT DEVICE: PRE-POWDERED STERILE EXAM GLOVES KANAM LATEX INDUSTRIES PVT. LTD. 510(k) NO: K052214(TRADITIONAL)
ATTN: RAVI ABRAHAM PHONE NO : 481 230 0343 OOPPOOTTIL BUILDING SE DECISION MADE: 13-SEP-05 P.O. BOX #28K.K. ROAD 510(k) STATEMENT KOTTAYAM, KERALA, INDIA 686001 DEVICE: AIDA COMPACT II SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K052159(SPECIAL)
ATTN: PAUL LEE PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 07-SEP-05 CULVER CITY, CA 90230-7600 510(k) STATEMENT DEVICE: ACCU-LEAD KENTEC MEDICAL, INC. 510(k) NO: K050443(TRADITIONAL)
ATTN: DAVID SHERATON PHONE NO : 949-472-9346 20492 CRESCENT BAY DR SE DECISION MADE: 02-SEP-05 SUITE 106 510(k) SUMMARY AVAILABLE FROM FDA LAKE FOREST, CA 92630 DEVICE: MBARESORB IMPLANT KINETIKOS MEDICAL, INC. 510(k) NO: K051611(TRADITIONAL)
ATTN: JOHN G SPAMPINATO PHONE NO : 760-448-1706 6005 HIDDEN VALLEY RD, STE 180 SE DECISION MADE: 06-SEP-05 CARLSBAD, CA 92011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: O.A.S.I. SYSTEM LANCER ORTHODONTICS, INC. 510(k) NO: K051552(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 19-SEP-05 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS LAR MFG., LLC. 510(k) NO: K052245(TRADITIONAL)
ATTN: IAN P GORDON PHONE NO : 727-797-4727 2454 MCMULLEN BOOTH ROAD SE DECISION MADE: 23-SEP-05 SUITE 427 510(k) SUMMARY AVAILABLE FROM FDA CLEARWATER, FL 33759 DEVICE: LEVITRONIX CENTRIMAG BACK-UP CONSOLE LEVITRONIX LLC. 510(k) NO: K051209(SPECIAL)
ATTN: FARZAD PARSAIE PHONE NO : 781-622-5075 45 FIRST AVE. SE DECISION MADE: 08-SEP-05 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-STIM II LHASA OMS, INC. 510(k) NO: K050435(TRADITIONAL)
ATTN: MARK W SHEEHAN PHONE NO : 781-340-1072 230 LIBBEY PKWY. SE DECISION MADE: 06-SEP-05 WEYMOUTH, MA 02189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTE LIFECORE BIOMEDICAL, INC. 510(k) NO: K051614(ABBREVIATED)
ATTN: RACHEL KENNEDY PHONE NO : 952-368-4300 3515 LYMAN BLVD. SE DECISION MADE: 09-SEP-05 CHASKA, MN 55318-3015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECT LUMENIS, INC. 510(k) NO: K051944(TRADITIONAL)
ATTN: KAREN L BAKER PHONE NO : 408-764-3603 2400 CONDENSA ST. SE DECISION MADE: 30-SEP-05 SANTA CLARA, CA 95051-0901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 MARDA MEDICAL, INC. 510(k) NO: K050524(TRADITIONAL)
ATTN: HOWARD SCHRAYER PHONE NO : 609-924-9510 895 NE DIXIE HIGHWAY SE DECISION MADE: 14-SEP-05 SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA JENSEN BEACH, FL 34957 DEVICE: F-400 SYSTEM MAUNA KEA TECHNOLOGIES 510(k) NO: K051585(TRADITIONAL)
ATTN: ALEXANDRE LOISEAU PHONE NO : 331 482 40621 9, RUE D'ENGHIEN SE DECISION MADE: 06-SEP-05 PARIS, FRANCE 75010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES MAZOR SURGICAL TECHNOLOGIES LTD. 510(k) NO: K051676(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 9 7670002 BEIT HAPA'AMON BOX 124 SE DECISION MADE: 08-SEP-05 20 HATA'AS (ROOM 213) 510(k) SUMMARY AVAILABLE FROM FDA KFAR SABA, ISRAEL 44425 DEVICE: TRU-SWAB STOCOCK MEDEGEN MEDICAL MANUFACTURING SERV510(k) NO: K052330(TRADITIONAL)
ATTN: TIM TRUITT PHONE NO : 909-390-9080 930 WANAMAKER AVE. SE DECISION MADE: 09-SEP-05 ONTARIO, CA 91761 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM MEDICAL DEVICE ADVISORY DEVELOPMEN510(k) NO: K051697(TRADITIONAL)
ATTN: C. STEPHEN LAWRENCE PHONE NO : 949-440-0400 CENTURY CENTRE SE DECISION MADE: 21-SEP-05 2603 MAIN STREET, SUITE 1170 510(k) SUMMARY AVAILABLE FROM FDA IRVINE, CA 92614 DEVICE: DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE MEDISIM LTD. 510(k) NO: K051422(SPECIAL)
ATTN: AHAVA STEIN PHONE NO : 972 976 70002 BEIT HAPA'AMON BOX 124 SE DECISION MADE: 01-SEP-05 20 HATA'AS ST 510(k) SUMMARY AVAILABLE FROM FDA KFAR SABA, ISRAEL 44425 DEVICE: DUREPAIR DURA REGENERATION MATRIX MEDTRONIC NEUROSURGERY 510(k) NO: K052211(SPECIAL)
ATTN: JEFFREY HENDERSON PHONE NO : 805-968-1546 125 CREMONA DR. SE DECISION MADE: 14-SEP-05 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K052372(SPECIAL)
ATTN: RONALD W BENNETT PHONE NO : 763-391-9086 7611 NORTHLAND DR. SE DECISION MADE: 22-SEP-05 MINNEAPOLIS, MN 55038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SATELLITE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K051320(TRADITIONAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 09-SEP-05 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K052376(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 23-SEP-05 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERMEZZO IMPLANT SYSTEMS MEGAGEN CO., LTD. 510(k) NO: K051018(TRADITIONAL)
ATTN: DAE KYU CHANG PHONE NO : 562-404-8466 13340 E. FIRESTONE BLVD. SE DECISION MADE: 02-SEP-05 SUITE J 510(k) SUMMARY AVAILABLE FROM FDA SANTA FE SPRINGS, CA 90670 DEVICE: MERRIES UNI-OSTEO, MODEL CS30250-CS10102 MERRIES INTERNATIONAL INC. 510(k) NO: K051698(TRADITIONAL)
ATTN: JESSICA LI PHONE NO : 886 289 117712 2F 3-1, BAU-HUNG RD. SE DECISION MADE: 29-SEP-05 SHIN-TIEN, TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS MICROMEDICS, INC. 510(k) NO: K051157(TRADITIONAL)
ATTN: TOM A LOPAC PHONE NO : 651-452-1977 1270 EAGAN INDUSTRIAL ROAD SE DECISION MADE: 01-SEP-05 SUITE 120 510(k) STATEMENT EAGAN, MN 55121 DEVICE: TEVADAPTOR DRUG RECONSTITUTION AND TRANSFER SYSTEM MIGADA PLANT 510(k) NO: K051669(TRADITIONAL)
ATTN: YOSSI SHACHAR PHONE NO : 972 469 08826 PO BOX 888 SE DECISION MADE: 01-SEP-05 KIRYAT SHMONA, ISRAEL 10258 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOLOTENS DENTAL TM 1 NEUROMUSCULAR TECHNOLOGIES, INC. 510(k) NO: K043373(ABBREVIATED)
ATTN: MARIE JENSEN PHONE NO : 503-320-4406 17720 JEAN WAY SE DECISION MADE: 02-SEP-05 #200 510(k) SUMMARY AVAILABLE FROM FDA LAKE OSWEGO, OR 97035 DEVICE: B-BOP PLATE NEWDEAL S.A. 510(k) NO: K052152(TRADITIONAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311 311 ENTERPRISE DRIVE SE DECISION MADE: 13-SEP-05 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAPERED COMPRESSION PIN NEXA ORTHOPEDICS, INC. 510(k) NO: K051740(TRADITIONAL)
ATTN: LOUISE M FOCHT PHONE NO : 760-599-1670 990 PARK CENTER DR., SUITE H SE DECISION MADE: 06-SEP-05 VISTA, CA 92081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NISSIN SERIES MECHANICAL WHEELCHAIR NISSIN MEDICAL INDUSTRIES CO., LTD510(k) NO: K052521(TRADITIONAL)
ATTN: DARREN REEVES PHONE NO : 804-307-7706 15637 FOX COVE CIRCLE SE DECISION MADE: 26-SEP-05 MOSELEY, VA 23120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NPAC MULTI-USE EAR THERMOMETER, MODELS TP 700,TP 702 NORM PACIFIC AUTOMATION CORP. 510(k) NO: K051835(SPECIAL)
ATTN: CHI-CHU WU CHEN PHONE NO : 886 357 85853 3F, NO. 31, HU-PIN ROAD #1 SE DECISION MADE: 23-SEP-05 SBIP 510(k) STATEMENT HSIN-CHU, CHINA (TAIWAN) DEVICE: SPINA SYSTEM NORTH AMERICAN MEDICAL CORP (NAM) 510(k) NO: K033231(TRADITIONAL)
ATTN: GIDGETTE RUBIN PHONE NO : 770-541-0012 3350 RIVERWOOD PKWY. SE DECISION MADE: 09-SEP-05 SUITE 1900 510(k) STATEMENT ATLANTA, GA 30339 DEVICE: NSTRAND IMPLANTATION KIT NORTH AMERICAN SCIENTIFIC, INC. 510(k) NO: K052024(TRADITIONAL)
ATTN: LEIGH SPOTTEN PHONE NO : 818-734-8600 20200 SUNBURST ST. SE DECISION MADE: 07-SEP-05 CHATSWORTH, CA 91311 510(k) STATEMENT DEVICE: NUVASIVE NEUROVISION JJB SYSTEM NUVASIVE, INC. 510(k) NO: K051718(TRADITIONAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1800 4545 TOWNE CENTRE CT. SE DECISION MADE: 15-SEP-05 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAREVENT ATV+ AND CAREVENT MRI O-TWO MEDICAL TECHNOLOGIES, INC. 510(k) NO: K051469(TRADITIONAL)
ATTN: AMMAR AL-DOJALLY PHONE NO : 905 677 9410 7575 KIMBEL ST. SE DECISION MADE: 28-SEP-05 MISSISSAUGA, ONTARIO, CANADA L5S 1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K052452(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE CENTER DR. SE DECISION MADE: 21-SEP-05 MELVILLE, NY 11747-9058 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL OMRON HEALTHCARE, INC. 510(k) NO: K052153(TRADITIONAL)
ATTN: IWAO KOJIMA PHONE NO : 847-247-5730 1200 LAKESIDE DRIVE SE DECISION MADE: 08-SEP-05 BANNOCKBURN, IL 60015 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC OMRON HEALTHCARE, INC. 510(k) NO: K052154(TRADITIONAL)
ATTN: IWAO KOJIMA PHONE NO : 847-247-5730 1200 LAKESIDE DRIVE SE DECISION MADE: 08-SEP-05 BANNOCKBURN, IL 60015 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: 20G SMA LASER FIBER, MODEL LF100 OPHTHALMED LLC 510(k) NO: K050807(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 770-777-6613 1308 MORNINGSIDE PARK DR. SE DECISION MADE: 21-SEP-05 ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS ORTHO DEVELOPMENT CORP. 510(k) NO: K050637(TRADITIONAL)
ATTN: WILLIAM J GRIFFIN PHONE NO : 801-619-3470 12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 23-SEP-05 DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEGEND ALL-POLY CUP ORTHO DEVELOPMENT CORP. 510(k) NO: K051407(TRADITIONAL)
ATTN: WILLIAM J GRIFFIN PHONE NO : 801-619-3470 12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 08-SEP-05 DRAPER, UT 84020 510(k) STATEMENT DEVICE: MIOT PLATING SYSTEM ORTHOFIX SRL 510(k) NO: K051945(TRADITIONAL)
ATTN: CANDACE F CEDERMAN PHONE NO : 910-509-0403 632 DUNDEE DRIVE SE DECISION MADE: 06-SEP-05 WILMINGTON, NC 28405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SC CERAMIC BALL HEADS ORTHOPEDIC ALLIANCE LLC 510(k) NO: K052237(SPECIAL)
ATTN: HARTMUT LOCH PHONE NO : 951-304-9001 41558 EASTMAN DRIVE SE DECISION MADE: 06-SEP-05 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA MURRIETA, CA 92562 DEVICE: OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 OSMETECH, INC. 510(k) NO: K052027(TRADITIONAL)
ATTN: DANIEL MCMINN PHONE NO : 770-510-4444 235 HEMBREE PARK DRIVE SE DECISION MADE: 29-SEP-05 ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVANA DENTAL IMPLANT SYSTEM OSSTEM CO., LTD. 510(k) NO: K051576(TRADITIONAL)
ATTN: ALBERT REGO PHONE NO : 949-770-8710 27001 LA PAZ ROAD, SUITE #312 SE DECISION MADE: 01-SEP-05 MISSION VIEJO, CA 92691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIWAVE XR PACIFIC QUANTUM INSTRUMENTS, INC. 510(k) NO: K051876(ABBREVIATED)
ATTN: GENNADY L NIKOLAENKO PHONE NO : 805-640-8080 408 BRYANT CIRCLE, SUITE F-1 SE DECISION MADE: 09-SEP-05 OJAI, CA 93023 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-PORT PATTON MEDICAL DEVICES 510(k) NO: K052389(ABBREVIATED)
ATTN: FRED SCHLADOR PHONE NO : 208-939-3447 PO BOX 1490 SE DECISION MADE: 09-SEP-05 EAGLE, ID 83616 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AV-S ANAESTHESIA VENTILATOR PENLON LIMITED 510(k) NO: K051222(TRADITIONAL)
ATTN: BARRY PEARCE PHONE NO : 235 547 000 25 BARKER CLOSE SE DECISION MADE: 23-SEP-05 FISHBOURNE, CHICHESTER 510(k) SUMMARY AVAILABLE FROM FDA WEST SUSSEX, UNITED KINGDOM PO18 8BJ DEVICE: CYSTOGLIDE DILATING INTRODUCER SHEATH PERCUTANEOUS SYSTEMS, INC. 510(k) NO: K052134(TRADITIONAL)
ATTN: THOMAS LAWSON PHONE NO : 650-969-8800 1300 CRITTENDEN LANE SE DECISION MADE: 22-SEP-05 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA MOUNTAIN VIEW, CA 94043-1359 DEVICE: ACCORDION PERCUTANEOUS SYSTEMS, INCORPORATED510(k) NO: K052048(TRADITIONAL)
ATTN: THOMAS LAWSON PHONE NO : 650-969-8800 1300 CRITTENDEN LANE SE DECISION MADE: 13-SEP-05 SUITE 301 510(k) SUMMARY AVAILABLE FROM FDA MOUNTAIN VIEW, CA 94043 DEVICE: VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221 PHASEIN AB 510(k) NO: K051857(TRADITIONAL)
ATTN: DAVID WEISSBURG PHONE NO : 608-770-0223 4213 WINNEQUAH DRIVE SE DECISION MADE: 15-SEP-05 MADISON, WI 53716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A PHILIPS MEDICAL SYSTEMS 510(k) NO: K051134(TRADITIONAL)
ATTN: DANIEL J DILLON PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 08-SEP-05 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K052078(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312 22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 07-SEP-05 P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98041-8431 DEVICE: PICONIBP OEM MODULE PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K051366(TRADITIONAL)
ATTN: MARKUS STACHA PHONE NO : 49 703 14632840 HEWLETT-PACKARD STR.2 SE DECISION MADE: 14-SEP-05 BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECT PHYSIOMETRIX, INC. 510(k) NO: K051874(SPECIAL)
ATTN: DAWN E FRAZER PHONE NO : 978-670-2422 FIVE BILLERICA PARK, SE DECISION MADE: 02-SEP-05 101 BILLERICA AVE. 510(k) SUMMARY AVAILABLE FROM FDA NORTH BILLERICA, MA 01862 DEVICE: PORTAL GRAVITY SYSTEM PORTAL, INC. 510(k) NO: K052579(TRADITIONAL) ATTN: DAVID CARTER PHONE NO : 866-253-7226 1350 NORTH 200 WEST, #6 SE DECISION MADE: 27-SEP-05 P.O. BOX 6141 510(k) SUMMARY AVAILABLE FROM FDA LOGAN, UT 84341 THIRD PARTY REVIEW DEVICE: POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K052415(SPECIAL)
ATTN: BARBARA J WHITMAN PHONE NO : 267-775-8151 2021 CABOT BLVD. SE DECISION MADE: 29-SEP-05 LANGHORNE, PA 19047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRAXAIR MEDICAL AIR MIXER PRAXAIR, INC. 510(k) NO: K051192(TRADITIONAL)
ATTN: TAMARA BROWN PHONE NO : 716-879-7465 175 EAST PARK DR. SE DECISION MADE: 06-SEP-05 2/144 510(k) SUMMARY AVAILABLE FROM FDA TONAWANDA, NY 14150 DEVICE: PREMIER TEMPORARY CEMENT PREMIER DENTAL PRODUCTS CO. 510(k) NO: K051866(TRADITIONAL)
ATTN: VINCE D'ALESSANDRO PHONE NO : 610-239-6000 1710 ROMANO DR. SE DECISION MADE: 06-SEP-05 PLYMOUTH MEETING, PA 19462 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Z-CHAIR PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K052353(SPECIAL)
ATTN: THOMAS SCHAPPERT PHONE NO : 570-655-5574 182 SUSQUEHANNA AVE. SE DECISION MADE: 09-SEP-05 EXETER, PA 18643 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-NEB AAD SYSTEM PROFILE THERAPEUTICS PLC 510(k) NO: K042991(TRADITIONAL)
ATTN: BARBARA CAMPBELL PHONE NO : 724-387-4557 CORPORATE SERVICES SE DECISION MADE: 23-SEP-05 1010 MURRY RIDGE LANE 510(k) SUMMARY AVAILABLE FROM FDA MURRYSVILLE, PA 15668-8525 DEVICE: PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH PROTON HEALTHCARE LTD. 510(k) NO: K051565(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LANE SE DECISION MADE: 12-SEP-05 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERIL PT. MAHAKARYA INTI BUANA 510(k) NO: K052273(TRADITIONAL)
ATTN: SASITHARAN NAIR PHONE NO : 626 179 44880 J1. SEI BELUMAI, DESA DALU 10 SE DECISION MADE: 30-SEP-05 A DUSUN I NO. 18, TANJUNG 510(k) SUMMARY AVAILABLE FROM FDA MORAWA, SUMUT, INDONESIA 20362 DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, BLUE PT. SHAMROCK MANUFACTURING CORP. 510(k) NO: K052382(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 909-591-8855 5445 DANIELS STREET SE DECISION MADE: 15-SEP-05 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE QUILL MEDICAL, INC. 510(k) NO: K052373(ABBREVIATED)
ATTN: LOIS V SMART PHONE NO : 919-806-1961 2505 MERIDIAN PARKWAY SE DECISION MADE: 26-SEP-05 SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA RESEARCH TRIANGLE PARK, NC 27713 DEVICE: R&R EXTERNAL FIXATION SYSTEM R&R MEDICAL, INC. 510(k) NO: K052005(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD SE DECISION MADE: 06-SEP-05 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY RADIANCY (ISRAEL) LTD. 510(k) NO: K051671(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 02-SEP-05 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES RADIANT INNOVATION INC. 510(k) NO: K051269(SPECIAL)
ATTN: FRANK LIN PHONE NO : 886 361 11666 1F, NO. 3 INDUSTRIAL E. 9TH RD SE DECISION MADE: 09-SEP-05 SCIENCE-BASED INDUSTRIAL PARK, 510(k) SUMMARY AVAILABLE FROM FDA HSIN CHU, CHINA (TAIWAN) DEVICE: POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE RAMSOFT, INC. 510(k) NO: K052460(TRADITIONAL)
ATTN: VIJAY RAMANATHAN PHONE NO : 416 674 1347 16 FOUR SEASONS PLACE SE DECISION MADE: 21-SEP-05 SUITE 215 510(k) SUMMARY AVAILABLE FROM FDA TORONTO, CANADA M9B 6E5 DEVICE: ACTIHEART RESPIRONICS, INC. 510(k) NO: K052489(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120 1001 MURRY RIDGE LN. SE DECISION MADE: 27-SEP-05 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VANISHPOINT I.V. CATHETER RETRACTABLE TECHNOLOGIES, INC. 510(k) NO: K051355(TRADITIONAL)
ATTN: MICHELE LARIOS PHONE NO : 972-294-1010 511 LOBO LN. SE DECISION MADE: 23-SEP-05 LITTLE ELM, TX 75068-0009 510(k) STATEMENT DEVICE: ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE ROCHE DIAGNOSTICS CORP. 510(k) NO: K050760(TRADITIONAL)
ATTN: SCOTT THIEL PHONE NO : 800-428-5074 9115 HAGUE RD. SE DECISION MADE: 13-SEP-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS O ROCHE DIAGNOSTICS CORP. 510(k) NO: K051297(TRADITIONAL) ATTN: KAY A TAYLOR PHONE NO : 317-521-3544 9115 HAGUE RD. SE DECISION MADE: 08-SEP-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ACCU-CHEK GO SYSTEM ROCHE DIAGNOSTICS CORP. 510(k) NO: K051592(TRADITIONAL)
ATTN: DIMITRIS DEMIRTZOGLOU PHONE NO : 317-521-7688 9115 HAGUE RD. SE DECISION MADE: 02-SEP-05 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST ROCHE DIAGNOSTICS CORP. 510(k) NO: K052464(SPECIAL)
ATTN: THERESA M AMBROSE PHONE NO : 317-521-3544 9115 HAGUE RD. SE DECISION MADE: 30-SEP-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MOD SAEHAN CORP. 510(k) NO: K052309(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931-937-8093 340 SHADY GROVE ROAD SE DECISION MADE: 27-SEP-05 FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAF-T-SYRINGE/SAF-T-NEEDLE SAFETY MEDICAL INTERNATIONAL, INCO510(k) NO: K051762(TRADITIONAL)
ATTN: DAVID ZARRILLI PHONE NO : 407-880-2301 2055 SPRINT BLVD. SE DECISION MADE: 23-SEP-05 APOPKA, FL 32703 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER SALTER LABS 510(k) NO: K051313(TRADITIONAL)
ATTN: DUANE KAZAL PHONE NO : 661-854-3166 100 W. SYCAMORE RD. SE DECISION MADE: 15-SEP-05 ARVIN, CA 93203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE SAVION INDUSTRIES " MEDI-CRUISER" MODEL MS777 SAVION INDUSTRIES, LTD. 510(k) NO: K051861(TRADITIONAL)
ATTN: STELI LOZNEN PHONE NO : 972 364 67804 P.O. BOX 4076 SE DECISION MADE: 28-SEP-05 ASHDOD, ISRAEL 77140 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED SCANTIBODIES LABORATORY, INC. 510(k) NO: K051810(TRADITIONAL)
ATTN: MICHAEL NORDSTROM PHONE NO : 619-258-9300 9336 ABRAHAM WAY SE DECISION MADE: 09-SEP-05 SANTEE, CA 92071 510(k) STATEMENT DEVICE: EUGENONE SCIENTIFIC PHARMACEUTICALS, INC. 510(k) NO: K051952(TRADITIONAL)
ATTN: JAN A ORLOWSKI PHONE NO : 909-595-9922 3221 PRODUCER WAY SE DECISION MADE: 07-SEP-05 POMONA, CA 91768-3916 510(k) STATEMENT DEVICE: NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLO SGMP CO., LTD. 510(k) NO: K052016(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 01-SEP-05 SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE, YELLO SHIJIAZHUANG MANFUL LIGHT INDUSTRI510(k) NO: K051924(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 RM 1606, BLDG 1 JIANXIANG YUAN SE DECISION MADE: 02-SEP-05 NO 209 BIE SI HUAN ZHONG ROAD 510(k) SUMMARY AVAILABLE FROM FDA HAIDIAN DISTRICT, BEIJING, CHINA 100083 DEVICE: DAR-8000I SHIMADZU MEDICAL SYSTEMS 510(k) NO: K052076(ABBREVIATED)
ATTN: RANDAL WALKER PHONE NO : 310-217-8855 20101 SOUTH VERMONT AVE. SE DECISION MADE: 02-SEP-05 TORRANCE, CA 90502-1328 510(k) STATEMENT DEVICE: POWDERED LATEX PATIENT EXAMINATION GLOVES SHINEMOUND ENTERPRISE, INC. 510(k) NO: K051913(TRADITIONAL)
ATTN: HUAN-CHUNG LI PHONE NO : 978-436-9980 17A STERLING RD. SE DECISION MADE: 30-SEP-05 NORTH BILLERICA, MA 01862 510(k) STATEMENT DEVICE: SURGEON'S GLOVE, POWDER FREE SHUN THAI RUBBER GLOVES INDUSTRY P510(k) NO: K052030(TRADITIONAL)
ATTN: ANAN JETSADAWISUT PHONE NO : 006 638 634072 9 MOO 4 KACHED MUANG SE DECISION MADE: 13-SEP-05 RAYONG, THAILAND 21110 510(k) STATEMENT DEVICE: POWDERED LATEX SURGEON'S GLOVE SHUN THAI RUBBER GLOVES INDUSTRY P510(k) NO: K052031(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 12-SEP-05 SPARKS, NV 89434 510(k) STATEMENT DEVICE: SYNGO IMAGING VERSION V20A SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K052461(TRADITIONAL)
ATTN: EVA-MARIA REITER PHONE NO : 499 131 842680 HENKESTRASSE 127 SE DECISION MADE: 22-SEP-05 ERLANGEN, GERMANY 91052 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K052305(TRADITIONAL)
ATTN: BARRY V ASHAR PHONE NO : 603-890-3311 45 STILES ROAD SE DECISION MADE: 08-SEP-05 SALEM, NH 03079 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SIMTEC IM-MAXX 2 OPTION SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K052315(SPECIAL)
ATTN: CHRISTINE DUNBAR PHONE NO : 925-602-8139 4040 NELSON AVE. SE DECISION MADE: 22-SEP-05 CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSON SEQUOIA ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K052410(SPECIAL)
ATTN: ISKRA MRAKOVIC PHONE NO : 650-694-5004 1230 SHOREBIRD WAY SE DECISION MADE: 22-SEP-05 P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA MOUNTAIN VIEW, CA 94039-7393 DEVICE: SOMATOM DEFINITION SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K052216(TRADITIONAL)
ATTN: GARY JOHNSON PHONE NO : 610-448-1778 51 VALLEY STREAM PARKWAY E-50 SE DECISION MADE: 08-SEP-05 MALVERN, PA 19355-1406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SISTEMA DE IMPLANTE NACIONAL (S.I.N.); DENTAL IMPLANT SYSTEM SIN SISTEMA DE IMPLANTE NACIONAL L510(k) NO: K051859(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235 11234 EL CAMINO REAL SE DECISION MADE: 23-SEP-05 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92130 DEVICE: IMPLANT HANDPIECES SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K051661(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 06-SEP-05 NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA SIS LTD. SURGICAL INSTRUMENT SYSTE510(k) NO: K051940(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LANE SE DECISION MADE: 28-SEP-05 LITTLETON, CO 80127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-STIM KIT SKYLARK DEVICE & SYSTEMS CO., LTD 510(k) NO: K050174(TRADITIONAL)
ATTN: BETTY CHIEN PHONE NO : 022 597 9001 4F, 34, SEC. 3, SE DECISION MADE: 07-SEP-05 CHUNG SHAN NORTH RD. 510(k) STATEMENT TAIPEI, CHINA (TAIWAN) DEVICE: SBI WRISTFIT SMALL BONE INNOVATIONS, LLC 510(k) NO: K051747(TRADITIONAL)
ATTN: DONALD GUTHNER PHONE NO : 212-583-0250 505 PARK AVE., 14TH FLOOR SE DECISION MADE: 06-SEP-05 NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DR. OPPEL ST-501 SOMETECH INCORPORATED 510(k) NO: K051956(TRADITIONAL)
ATTN: YOUNG-SOO SEOL PHONE NO : +82 220 252530 2F, BYUKSAN DIGITAL VALLEY III SE DECISION MADE: 08-SEP-05 212-13, GURODONG, GURO-KU 510(k) SUMMARY AVAILABLE FROM FDA SEOUL, REPUBLIC OF KOREA 152-050 THIRD PARTY REVIEW DEVICE: CLIRPATH TURBO EXCIMER LASER CATHETERS SPECTRANETICS CORP. 510(k) NO: K052296(TRADITIONAL)
ATTN: NEIL BURRIS PHONE NO : 719-442-2456 96 TALAMINE CT. SE DECISION MADE: 02-SEP-05 COLORADO SPRINGS, CO 80907-5159 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDO-EASE ENDOSCOPIC OVERTUBE SPIRUS MEDICAL, INC. 510(k) NO: K052084(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVENUE SE DECISION MADE: 14-SEP-05 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HIPAX MEDICAL IMAGING SOFTWARE STEINHART MEDIZINSYSTEME GMBH 510(k) NO: K052411(TRADITIONAL)
ATTN: MARTINA STEINHART PHONE NO : 490 766 690070 6-8 GRUBSTRASSE SE DECISION MADE: 21-SEP-05 VORSTETTEN, GERMANY D-79279 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: REPROCESSED EXTERNAL FIXATION DEVICE STERILEMED INC. 510(k) NO: K051957(TRADITIONAL)
ATTN: THOMAS A DOLD PHONE NO : 763-488-3400 11400 73RD AVE. N. SE DECISION MADE: 21-SEP-05 MENNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYRYKER SORANO WHEELCHAIR STRYKER CANADA 510(k) NO: K051369(TRADITIONAL)
ATTN: SHERYL ROBINSON BAGALIO PHONE NO : 905 690 5700 -2237 45 INNOVATION DRIVE SE DECISION MADE: 26-SEP-05 HAMILTON ONTARIO, CANADA L9H 7L8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCOLADE HFX FEMORAL STEM STRYKER ORTHOPAEDICS 510(k) NO: K051741(TRADITIONAL)
ATTN: TIFFANI ROGERS PHONE NO : 201-831-5412 325 CORPORATE DRIVE SE DECISION MADE: 26-SEP-05 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCOLADE RPS HIP STEM STRYKER ORTHOPAEDICS 510(k) NO: K052542(SPECIAL)
ATTN: TIFFANI ROGERS PHONE NO : 201-831-5612 325 CORPORATE DRIVE SE DECISION MADE: 27-SEP-05 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO XIA SPINAL SYSTEM STRYKER SPINE 510(k) NO: K052181(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145 2 PEARL COURT SE DECISION MADE: 08-SEP-05 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: STRYKER SPINE OASYS SYSTEM STRYKER SPINE 510(k) NO: K052317(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145 2 PEARL COURT SE DECISION MADE: 21-SEP-05 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALL PURPOSE CUFF, MODEL 222APC SUNTECH MEDICAL, INC. 510(k) NO: K051904(ABBREVIATED)
ATTN: DAVID GALLICK PHONE NO : 919-654-2332 507 AIRPORT BOULEVARD SE DECISION MADE: 09-SEP-05 SUITE 117 510(k) SUMMARY AVAILABLE FROM FDA MORRISVILLE, NC 27560 DEVICE: SUPERDIMENSION/BRONCHUS 4.1 SUPERDIMENSION, LTD. 510(k) NO: K052260(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703 377 ROUTE 17 S SE DECISION MADE: 08-SEP-05 HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXY-SERVE II OXYGEN CONSERVING REGULATOR SUPERIOR PRODUCTS, INC. 510(k) NO: K051988(TRADITIONAL)
ATTN: RONALD JOHNSTON PHONE NO : 216-651-9400 3786 RIDGE RD. SE DECISION MADE: 21-SEP-05 CLEVELAND, OH 44144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS SYNERGEYES 510(k) NO: K051035(TRADITIONAL)
ATTN: RICHARD E LIPPMAN PHONE NO : 240-683-3738 15825 SHADY GROVE ROAD SE DECISION MADE: 02-SEP-05 SUITE 30 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20850 DEVICE: POLARIS LV, LVA APPLICATOR SYNERON MEDICAL LTD. 510(k) NO: K052324(SPECIAL)
ATTN: AMIR WALDMAN PHONE NO : 972 4 9096200 INDUSTRIAL ZONE SE DECISION MADE: 14-SEP-05 P.O.B. 550 510(k) SUMMARY AVAILABLE FROM FDA YOQNEAM ILLIT, ISRAEL 20692 DEVICE: SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM SYNTHES (USA) 510(k) NO: K051678(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-5868 1302 WRIGHTS LANE EAST SE DECISION MADE: 21-SEP-05 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES SYNTHES (USA) 510(k) NO: K051986(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-5868 1302 WRIGHTS LANE EAST SE DECISION MADE: 08-SEP-05 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES PANGEA SYSTEM SYNTHES (USA) 510(k) NO: K052123(SPECIAL)
ATTN: JOHN J WALSH PHONE NO : 610-718-5733 1302 WRIGHTS LANE EAST SE DECISION MADE: 23-SEP-05 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES VECTRA-T SYSTEM SYNTHES SPINE 510(k) NO: K051665(TRADITIONAL)
ATTN: SUSAN LEWANDOWSKI PHONE NO : 610-719-5712 1380 ENTERPRISE DR. SE DECISION MADE: 09-SEP-05 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER SYSMEX AMERICA, INC. 510(k) NO: K051459(TRADITIONAL)
ATTN: NINA GAMPERLING PHONE NO : 847-996-4675 ONE NELSON C. WHITE PARKWAY SE DECISION MADE: 23-SEP-05 MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORI SZABOCSIK AND ASSOCIATES 510(k) NO: K052074(TRADITIONAL)
ATTN: JOHN M SZABOCSIK PHONE NO : 312-553-0828 203 N.WABASH, SUITE 1200 SE DECISION MADE: 01-SEP-05 CHICAGO, IL 60601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TECHNO-SCOPE VISUAL STETHOSCOPE TECHTRADE LLC 510(k) NO: K050097(TRADITIONAL)
ATTN: ARTHUR M HOROWITZ PHONE NO : 301-468-9252 11900 GAINSBOROUGH ROAD SE DECISION MADE: 30-SEP-05 P.O.BOX 2005 510(k) SUMMARY AVAILABLE FROM FDA POTOMAC, MD 20854-3305 DEVICE: CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESE TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K051997(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866 125 BLUE BALL RD. SE DECISION MADE: 15-SEP-05 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPIOX AF125X ARTERIAL FILTER TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K052205(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866 125 BLUE BALL RD. SE DECISION MADE: 12-SEP-05 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR TERUMO MEDICAL CORP. 510(k) NO: K051865(TRADITIONAL)
ATTN: BARBARA SMITH PHONE NO : 410-392-7241 125 BLUE BALL RD. SE DECISION MADE: 27-SEP-05 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DESTINATION CAROTID GUIDING SHEATH TERUMO MEDICAL CORP. 510(k) NO: K052185(SPECIAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7231 125 BLUE BALL RD. SE DECISION MADE: 06-SEP-05 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER A THE BINDING SITE, LTD. 510(k) NO: K051915(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 06-SEP-05 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 THERALIGHT, INC. 510(k) NO: K051259(TRADITIONAL)
ATTN: KEVIN E DALY PHONE NO : 760-930-8000 2794 LOKER AVE. WEST,SUITE 105 SE DECISION MADE: 20-SEP-05 CARLSBAD, CA 92008-6616 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL S THERMO-ELECTRON CORP. 510(k) NO: K052056(TRADITIONAL)
ATTN: MELITA LAMBIRIS PHONE NO : 613 979 04100 189-199 BROWNS RD. SE DECISION MADE: 23-SEP-05 NOBLE PARK, VICTORIA, AUSTRALIA 31510(k) STATEMENT DEVICE: 21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3M TOTOKU ELECTRIC CO., LTD 510(k) NO: K052199(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : +81 268 345484 300 OYA SE DECISION MADE: 22-SEP-05 UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANS1 FACET SCREWS TRANS1 INCORPORATED 510(k) NO: K051856(TRADITIONAL)
ATTN: ROBERT L SHERIDAN PHONE NO : 910-509-3100 1800 SIR TYLER DRIVE SE DECISION MADE: 26-SEP-05 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA WILMINGTON, NC 28405 DEVICE: SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K052091(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909 982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 21-SEP-05 CLEVELAND, OH 44131 510(k) STATEMENT DEVICE: AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER TRUDELL MEDICAL INTL. 510(k) NO: K052332(SPECIAL)
ATTN: JOHN STRAATMAN PHONE NO : 151 945 57060 2131 725 THIRD ST. SE DECISION MADE: 21-SEP-05 LONDON, ONTARIO, CANADA N5V 5G4 510(k) STATEMENT DEVICE: AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS U-SYSTEMS, INC. 510(k) NO: K052355(SPECIAL)
ATTN: ROBERT F LAWRENCE PHONE NO : 408-750-1323 110 ROSE ORCHARD WAY SE DECISION MADE: 14-SEP-05 SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 ULTRADENT PRODUCTS, INC. 510(k) NO: K051750(TRADITIONAL)
ATTN: TAMMY LAVERY PHONE NO : 801-552-5512 505 WEST 10200 SOUTH SE DECISION MADE: 19-SEP-05 SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIPLAIN & UNICHROM UNITED MEDICAL INDUSTRIES CO. LTD.510(k) NO: K042287(TRADITIONAL)
ATTN: MOHAMMED AZEEZ PHONE NO : 009 661 2650665 P.O. BOX 51871 SE DECISION MADE: 07-SEP-05 RIYADH, CENTRAL PROVINCE, SAUDI AR510(k) STATEMENT DEVICE: COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT UNOMEDICAL A/S 510(k) NO: K051264(TRADITIONAL)
ATTN: JOHN LINDSKOG PHONE NO : 454 642 7810 AAHOLMVEJ 2, OSTED SE DECISION MADE: 01-SEP-05 ROSKILDE, DENMARK 4000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K051616(TRADITIONAL)
ATTN: HEATHER CRAWFORD PHONE NO : 863-683-8680 5307 GREAT OAK DR. SE DECISION MADE: 06-SEP-05 LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 VASCULAR CONTROL SYSTEMS, INC 510(k) NO: K052209(TRADITIONAL)
ATTN: KATHLEEN ROBERTS PHONE NO : 949-488-8700 32236 PASEO ADELANTO, STE. F SE DECISION MADE: 06-SEP-05 SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER VASCULAR SOLUTIONS, INC. 510(k) NO: K052232(TRADITIONAL)
ATTN: SARA L COON PHONE NO : 763-656-4399 6464 SYCAMORE COURT NORTH SE DECISION MADE: 28-SEP-05 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR VERSAMED MEDICAL SYSTEMS, INC. 510(k) NO: K052554(SPECIAL)
ATTN: JERRY KORTEN PHONE NO : 845-770-2840 2 BLUE HILL PLAZA SE DECISION MADE: 23-SEP-05 BLDG. 2, 3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA PEARL RIVER, NY 10965 DEVICE: VERTEBRON PSS PEDICLE SCREW SYSTEM VERTEBRON, INC. 510(k) NO: K051716(SPECIAL)
ATTN: LUIS NESPRIDO PHONE NO : 203-380-9340 400 LONG BEACH BLVD. SE DECISION MADE: 07-SEP-05 STRATFORD, CT 06615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE WELCH ALLYN, INC. 510(k) NO: K052158(SPECIAL)
ATTN: CHRISTOPHER KLACZYK PHONE NO : 315-685-3694 4341 STATE ST. RD. SE DECISION MADE: 08-SEP-05 SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WHITTLESTONE EXPRESSER WHITTLESTONE, INC. 510(k) NO: K051112(TRADITIONAL)
ATTN: BRUCE MCKENDRY PHONE NO : 877-608-6455 602 B STONE RD. SE DECISION MADE: 07-SEP-05 BENICIA, CA 94510 510(k) STATEMENT DEVICE: FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), WORLDWIDE MEDICAL LLC 510(k) NO: K051966(TRADITIONAL)
ATTN: KEVIN J GADAWSKI PHONE NO : 949-598-8378 13 SPECTRUM POINTE DR. SE DECISION MADE: 07-SEP-05 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINEAGE HA ACETABULAR SHELLS WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K043099(TRADITIONAL)
ATTN: JEANINE H REDDEN PHONE NO : 901-867-4522 5677 AIRLINE RD. SE DECISION MADE: 29-SEP-05 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WU'S POWERED WHEELCHAIR, MAMBO 2 WU'S TECH CO., LTD. 510(k) NO: K052559(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 26-SEP-05 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REFIX INTERNAL FRACTURE FIXATION SCREWS XTREMI-T, LLC 510(k) NO: K050388(TRADITIONAL)
ATTN: SHAWAN T HUXEL PHONE NO : 609-896-0008 3131 PRINCETON PIKE, BLDG. 5 SE DECISION MADE: 07-SEP-05 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA LAWRENCEVILLE, NJ 08648 DEVICE: ZIVF-AIRE ZANDER MEDICAL SUPPLIES, INC. 510(k) NO: K041952(TRADITIONAL)
ATTN: FRED ZANDER PHONE NO : 772-569-5955 755 8TH CT., SUITE #4 SE DECISION MADE: 08-SEP-05 P.O. BOX 650790 510(k) STATEMENT VERO BEACH, FL 32965-0790 DEVICE: ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM ZIMMER, INC. 510(k) NO: K050411(TRADITIONAL)
ATTN: CINDY J DICKEY PHONE NO : 330-364-9493 200 WEST OHIO AVENUE SE DECISION MADE: 02-SEP-05 P.O. BOX 10 510(k) SUMMARY AVAILABLE FROM FDA DOVER, OH 44622-0010 TOTAL 510(k)s THIS PERIOD 269 TOTAL WITH SUMMARIES 226 TOTAL WITH STATEMENTS 43
Updated October 6, 2005
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