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Medical Devices
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September 2005 510(k) Clearances
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
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