510(k)s Final Decisions Rendered for November 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-NOV-2005 THROUGH 30-NOV-2005
DEVICE: PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS
PNEUMRX, INC. 510(k) NO: K052435(TRADITIONAL)
ATTN: ANNE C WORDEN PHONE NO : 925-895-1200
530 LOGUE AVENUE SE DECISION MADE: 03-NOV-05
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT SPINE, INC. SPINNAKER SYSTEM
ABBOTT SPINE, INC. 510(k) NO: K052638(TRADITIONAL)
ATTN: LISA PETERSON PHONE NO : 512-533-1080
5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 07-NOV-05
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN
ACCESS BIO INCORPORATE 510(k) NO: K051925(TRADITIONAL)
ATTN: YOUNG HO CHOI PHONE NO : 732-297-2222
2033 RT. 130 UNIT H SE DECISION MADE: 29-NOV-05
MONMOUTH JCT., NJ 08852 510(k) STATEMENT
DEVICE: ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA
ACCUTRON, INC. 510(k) NO: K052335(TRADITIONAL)
ATTN: ROBERT N CLARK PHONE NO : 303-234-9412
13605 WEST 7TH AVENUE SE DECISION MADE: 23-NOV-05
GOLDEN, CO 80401-4604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPID PROGEAMMER 3.0
ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K052374(TRADITIONAL)
ATTN: KATRYNA WARREN PHONE NO : 972-309-8000
6901 PRESTON RD. SE DECISION MADE: 22-NOV-05
PLANO, TX 75024 510(k) STATEMENT
DEVICE: AESKULISA ASCA A
AESKU.INC 510(k) NO: K051492(TRADITIONAL)
ATTN: STANLEY AMMONS PHONE NO : 703-860-5057
8880 NORTHWEST 18TH TERRACE SE DECISION MADE: 14-NOV-05
MIAMI, FL 33172 510(k) STATEMENT
DEVICE: ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDE
ALDEN OPTICAL LABS., INC. 510(k) NO: K052703(TRADITIONAL)
ATTN: CHARLES H CREIGHTON PHONE NO : 716-937-9181
13295 BROADWAY SE DECISION MADE: 10-NOV-05
ALDEN, NY 14004 510(k) STATEMENT
DEVICE: REPROCESSED ELECTROPHYSIOLOGY CATHETER
ALLIANCE MEDICAL CORP. 510(k) NO: K052414(TRADITIONAL)
ATTN: ELIZABETH RENKEN PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 16-NOV-05
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS
ALLIANCE MEDICAL CORP. 510(k) NO: K052603(TRADITIONAL)
ATTN: ELIZABETH RENKEN PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 16-NOV-05
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLANAS POSTERIOR STABILIZATION SYSTEM
ALPHATEC SPINE, INC. 510(k) NO: K052201(TRADITIONAL)
ATTN: ELLEN A YARNALL PHONE NO : 760-431-9286
2051 PALOMAR AIRPORT ROAD SE DECISION MADE: 10-NOV-05
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92011
DEVICE: CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0
AMERICAN MEDICAL SALES, INC. 510(k) NO: K052537(ABBREVIATED)
ATTN: CAROL M LIFLAND PHONE NO : 800-423-3535
4928 WEST ROSECRANS AVE. SE DECISION MADE: 16-NOV-05
HAWTHORNE, CA 90250-6616 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINI-LASE SYSTEM, MODELS CL-BASE, CL-2000, CL-1200, CL-500, CL-
AMERICAN SPINE CENTER, LTD. 510(k) NO: K052647(TRADITIONAL)
ATTN: JAMES WHITE PHONE NO : 628-233-6824
100 MASCOUTAH AVENUE SE DECISION MADE: 09-NOV-05
BELLEVILLE, IL 62220-3801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX
ARTHREX, INC. 510(k) NO: K052387(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 29-NOV-05
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SC
ARTHREX, INC. 510(k) NO: K052607(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 07-NOV-05
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-
ARTHREX, INC. 510(k) NO: K052736(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 03-NOV-05
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTSANA PISTON AND INSULIN SYRINGES
ARTSANA S.P.A. 510(k) NO: K052667(ABBREVIATED)
ATTN: LARA N SIMMONS PHONE NO : 847-682-0224
22411 60TH STREET SE DECISION MADE: 25-NOV-05
BRISTOL, WI 53104 510(k) STATEMENT
DEVICE: ASAHI ANGIOGRAPHIC CATHETER
ASAHI INTECC CO., LTD. 510(k) NO: K051561(TRADITIONAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252
1301 DOVE STREET, SUITE #350 SE DECISION MADE: 02-NOV-05
NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI PTCA GUIDE WIRE
ASAHI INTECC CO., LTD. 510(k) NO: K052339(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252
1301 DOVE STREET, SUITE #350 SE DECISION MADE: 30-NOV-05
NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENSION MUH
ASCENSION ORTHOPEDICS, INC. 510(k) NO: K052137(TRADITIONAL)
ATTN: GLEN NEALLY PHONE NO : 512-836-5001
8700 CAMERON RD., STE. 100 SE DECISION MADE: 03-NOV-05
AUSTIN, TX 78754-3832 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIS EEG MONITOR, MODEL BISX4
ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K052981(SPECIAL)
ATTN: CHRISTINE VOZELLA PHONE NO : 617-559-7000
141 NEEDHAM ST. SE DECISION MADE: 01-NOV-05
NEWTON, MA 02464 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO: AURORA
AURORA IMAGING TECHNOLOGY, INC. 510(k) NO: K052698(SPECIAL)
ATTN: MICHAEL A DOUGLAS PHONE NO : 978-975-7530
39 HIGH ST. SE DECISION MADE: 08-NOV-05
NORTH ANDOVER, MA 01845 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCEDUR-10
AVANCA MEDICAL DEVICES, INC. 510(k) NO: K052075(SPECIAL)
ATTN: FRANK FERGUSON PHONE NO : 505-243-4600
801 UNIVERSITY BLVD. SE SE DECISION MADE: 09-NOV-05
SUITE 307 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87106
DEVICE: MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM
AVANT MEDICAL SYSTEMS 510(k) NO: K052541(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 03-NOV-05
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTRAST MEDIA TRANSFER SETS
B. BRAUN MEDICAL, INC. 510(k) NO: K052252(TRADITIONAL)
ATTN: CHRISTINE FORD PHONE NO : 610-266-0500
901 MARCON BLVD. SE DECISION MADE: 16-NOV-05
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B. BRAUN MODIFIED BICARBONATE DIALYSATE
B. BRAUN MEDICAL, INC. 510(k) NO: K052393(SPECIAL)
ATTN: CHRISTINE FORD PHONE NO : 610-596-2367
901 MARCON BLVD. SE DECISION MADE: 09-NOV-05
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLOR NIO 2MP, E-2320 C
BARCOVIEW 510(k) NO: K052958(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 325 623 3459
35 PRESIDENT KENNEDYPARK SE DECISION MADE: 16-NOV-05
KORTRIJK, BELGIUM B-8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERPICC
BARD ACCESS SYSTEMS, INC. 510(k) NO: K051672(TRADITIONAL)
ATTN: LYNN M KIRCHOFF PHONE NO : 801-595-0700
5425 WEST AMELIA EARNHART DR. SE DECISION MADE: 23-NOV-05
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL R
BARD PERIPHERAL VASCULAR, INC. 510(k) NO: K052578(SPECIAL)
ATTN: GENEVIEVE BALUTOWSKI PHONE NO : 480-303-2524
1625 WEST 3RD ST. SE DECISION MADE: 25-NOV-05
P.O. BOX 1740 510(k) SUMMARY AVAILABLE FROM FDA
TEMPE, AZ 85280
DEVICE: SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES
BARRIERMED GLOVE CO. 510(k) NO: K052892(TRADITIONAL)
ATTN: VICTOR J RAGUCCI PHONE NO : 407-771-4424
155 TECHNOLOGY PARK SE DECISION MADE: 30-NOV-05
LAKE MARY, FL 32746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENU WITH MOISTURELOC MULTI-PURPOSE SOLUTION
BAUSCH & LOMB, INC. 510(k) NO: K051755(TRADITIONAL)
ATTN: JENNIFER B MURRAY PHONE NO : 585-338-8460
1400 NORTH GOODMAN ST. SE DECISION MADE: 17-NOV-05
ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRICOS T
BAXTER HEALTHCARE CORP. 510(k) NO: K051722(TRADITIONAL)
ATTN: BRIAN L BISHOP PHONE NO : 805-372-3065
ONE BAXTER WAY SE DECISION MADE: 18-NOV-05
WESTLAKE VILLAGE, CA 91362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6
BAYLIS MEDICAL CO., INC. 510(k) NO: K053082(SPECIAL)
ATTN: MEGHAL KHAKHAR PHONE NO : 905 602 4875X252
2580 MATHESON BLVD. E SE DECISION MADE: 30-NOV-05
MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER
BECKMAN COULTER, INC. 510(k) NO: K052905(SPECIAL)
ATTN: STAN SUGRUE PHONE NO : 305-380-4552
11800 SW 147TH AVE. SE DECISION MADE: 18-NOV-05
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIGECYCLINE I5UG BBL SENSI-DISC
BECTON DICKINSON & CO. 510(k) NO: K052853(TRADITIONAL)
ATTN: DAINELLE CLARK PHONE NO : 410-316-4905
7 LOVETON CIR. SE DECISION MADE: 17-NOV-05
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TELITHROMYCIN 15UG BBL SENSI-DISC
BECTON DICKINSON & CO. 510(k) NO: K052876(TRADITIONAL)
ATTN: DAINELLE CLARK PHONE NO : 410-316-4905
7 LOVETON CIR. SE DECISION MADE: 14-NOV-05
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VIPER SYSTEM
BECTON, DICKINSON & CO. 510(k) NO: K052481(SPECIAL)
ATTN: COLLEEN A KISTLER PHONE NO : 410-316-4988
7 LOVETON CIR. SE DECISION MADE: 28-NOV-05
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENEROS 80, GENEROS 60
BERKELEY ADVANCED BIOMATERIALS, IN510(k) NO: K051914(SPECIAL)
ATTN: FRANCOIS GENIN PHONE NO : 510-883-0500
901 GRAYSON ST., SUITE 101 SE DECISION MADE: 03-NOV-05
BERKELEY, CA 94710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQR
BETTER WATER, INC. 510(k) NO: K051620(ABBREVIATED)
ATTN: MICHAEL CLINE PHONE NO : 615-355-6063
698 SWAN DR. SE DECISION MADE: 18-NOV-05
SMYRNA, TN 37167 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BINAXNOW INFLUENZA A & B TEST
BINAX, INC. 510(k) NO: K053126(TRADITIONAL)
ATTN: ANGELA DRYSDALE PHONE NO : 207-730-5700
10 SOUTHGATE RD. SE DECISION MADE: 30-NOV-05
SCARBOROUGH, ME 04074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLENDERTONE GYMBODY, MODEL 512-01
BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K052969(SPECIAL)
ATTN: MICHAEL O'SULLIVAN PHONE NO : 353 917 74300
PARKMORE BUSINESS PARK WEST SE DECISION MADE: 16-NOV-05
GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
BIO-RAD 510(k) NO: K052838(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO RD. SE DECISION MADE: 09-NOV-05
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN
BIOMERIEUX, INC. 510(k) NO: K052656(TRADITIONAL)
ATTN: JOLYN TENLLADO PHONE NO : 314-731-8386
595 ANGLUM DR. SE DECISION MADE: 07-NOV-05
HAZELWOOD, MO 63042-2320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS
BIOMET, INC. 510(k) NO: K052255(SPECIAL)
ATTN: ALLISON K KOSKEY PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 23-NOV-05
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46582
DEVICE: MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,1723
BIOPRO, INC. 510(k) NO: K052596(TRADITIONAL)
ATTN: DAVID MRAK PHONE NO : 810-982-7777
17 SEVENTEENTH ST. SE DECISION MADE: 15-NOV-05
PORT HURON, MI 48060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM
BLUE SKY MEDICAL GROUP INCORPORATE510(k) NO: K052456(SPECIAL)
ATTN: JASPER BENKE PHONE NO : 760-603-8130
5924 BALFOUR CT. SE DECISION MADE: 04-NOV-05
SUITE D 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92008
DEVICE: FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM
BOSTON SCIENTIFIC CORP. 510(k) NO: K052280(TRADITIONAL)
ATTN: DEBBIE MCINTIRE PHONE NO : 650-623-1600
2011 STIERLIN CT. SE DECISION MADE: 07-NOV-05
MOUNTAIN VIEW, CA 94043-4655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE
BOSTON SCIENTIFIC CORP. 510(k) NO: K053128(SPECIAL)
ATTN: NICHOLAS CONDAKES PHONE NO : 508-683-4003
100 FAIRBANKS BOULEVARD SE DECISION MADE: 30-NOV-05
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGATION SW HIP 3.1 ON CI
BRAINLAB AG 510(k) NO: K052213(SPECIAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8 SE DECISION MADE: 02-NOV-05
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS
CAESAREA MEDICAL ELECTRONICS LTD. 510(k) NO: K050800(TRADITIONAL)
ATTN: GALI TZURY PHONE NO : 972 4 6271737
16 SHACHAM STREET SE DECISION MADE: 23-NOV-05
P.O.B. 4294 510(k) STATEMENT
CAESAREA, ISRAEL 38900
DEVICE: CRONO FIVE AND CRONO PCA 50
CANE S.R.L. 510(k) NO: K052218(TRADITIONAL)
ATTN: CARLO MUSSO PHONE NO : 390 119 574872
VIA PAVIA, 105/I SE DECISION MADE: 23-NOV-05
RIVOLI-CASCINE VICA (TORINO), ITAL510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRC 15ULTRA
CAPINTEC, INC. 510(k) NO: K052595(TRADITIONAL)
ATTN: MARY ANNE DELL PHONE NO : 412-963-1099
540 ALPHA DR. SE DECISION MADE: 08-NOV-05
PITTSBURGH, PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES)
CARDICA, INC. 510(k) NO: K040832(TRADITIONAL)
ATTN: SEVRINA CIUCCI PHONE NO : 650-364-9975
900 SAGINAW DR. SE DECISION MADE: 10-NOV-05
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM
CARDINAL HEALTH 510(k) NO: K051226(TRADITIONAL)
ATTN: SHARON NICHOLS PHONE NO : 847-578-6610
1430 WAUKEGAN ROAD, BLDG. KB SE DECISION MADE: 17-NOV-05
MCGAW PARK, IL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESTEEM STRETCHY VINYL GLOVE WITH COATING
CARDINAL HEALTH 510(k) NO: K052568(TRADITIONAL)
ATTN: AMY HOYD PHONE NO : 847-578-2325
1500 WAUKEGAN RD. SE DECISION MADE: 28-NOV-05
BLDG. WM 510(k) SUMMARY AVAILABLE FROM FDA
MCGAW PARK, IL 60085 THIRD PARTY REVIEW
DEVICE: VISUCAM PRO NM
CARL ZEISS MEDITEC AG 510(k) NO: K052268(SPECIAL)
ATTN: KENT W JONES PHONE NO : 925-557-4353
5160 HACIENDA DRIVE SE DECISION MADE: 02-NOV-05
DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPRESSIX
CAVEX HOLLAND B.V. 510(k) NO: K052455(TRADITIONAL)
ATTN: RICHARD WOORTMAN PHONE NO : 011 312 35307763
HARMENJANSWEG 21 SE DECISION MADE: 23-NOV-05
HAARLEM, NETHERLANDS 2031 WH 510(k) STATEMENT
DEVICE: AQUADEX SYSTEM
CHF SOLUTIONS, INC. 510(k) NO: K050609(TRADITIONAL)
ATTN: CHRIS SCAVOTTO PHONE NO : 763-463-4621
7601 NORTHLAND DR. STE. 170 SE DECISION MADE: 09-NOV-05
BROOKLYN PARK, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLY SILOXANE IMPRESSION MATERIAL
CLINICIAN'S CHOICE DENTAL PRODUCTS510(k) NO: K053014(TRADITIONAL)
ATTN: JEANETTE SMITH PHONE NO : 519 641 3066
1980 HYDE PARK ROAD SE DECISION MADE: 15-NOV-05
LONDON, ONTARIO, CANADA N6H 5L9 510(k) STATEMENT
DEVICE: CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LI
CLINIQA CORPORATION 510(k) NO: K052679(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION RD. SE DECISION MADE: 18-NOV-05
FALLBROOK, CA 92028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS
COEUR, INC. 510(k) NO: K051799(TRADITIONAL)
ATTN: DEBRA F MANNING PHONE NO : 615-547-7923
704 CADET COURT SE DECISION MADE: 02-NOV-05
LEBANON, TN 37087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARACEM UNIVERSAL DC
COLTENE/WHALEDENT AG 510(k) NO: K053040(TRADITIONAL)
ATTN: HENRY J VOGELSTEIN PHONE NO : 212-289-4748
1349 LEXINGTON AVENUE SE DECISION MADE: 09-NOV-05
NEW YORK, NY 10128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTEFIX VERTEBROPLASTY PROCEDURE SET
COOK, INC. 510(k) NO: K042691(TRADITIONAL)
ATTN: JENNIFER J BOSLEY PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489 SE DECISION MADE: 08-NOV-05
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MREYE EMBOLIZATION COIL
COOK, INC. 510(k) NO: K052834(TRADITIONAL)
ATTN: LISA M WEBB PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489 SE DECISION MADE: 23-NOV-05
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIMPLANT
CYBERMED, INC. 510(k) NO: K053155(TRADITIONAL)
ATTN: SONG NAK CHOI PHONE NO : +82 233 973970
#504 SJ TECHNOVILLE, SE DECISION MADE: 23-NOV-05
GASAN-DONG 60-19, GEUMCHEON-GU 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, REPUBLIC OF KOREA 153-710 THIRD PARTY REVIEW
DEVICE: MODEL ELEXUS (MP3C-1) ELECTRIC WHEELCHAIR
DALTON MEDICAL CORP. 510(k) NO: K052496(TRADITIONAL)
ATTN: WILL RIDGWAY PHONE NO : 972-418-5129
1103 VENTURE CT. SE DECISION MADE: 04-NOV-05
CARROLLTON, TX 75006 510(k) STATEMENT
DEVICE: CARDIOSERVER
DATRIX 510(k) NO: K052883(TRADITIONAL)
ATTN: LINDA GLUCKMAN PHONE NO : 760-480-8874
340 STATE PLACE SE DECISION MADE: 01-NOV-05
ESCONDIDO, CA 92029 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DATRIX CARDIO WIFI ELECTROCARDIOGRAPH
DATRIX 510(k) NO: K053083(TRADITIONAL)
ATTN: LINDA GLUCKMAN PHONE NO : 760-480-8874
340 STATE PLACE SE DECISION MADE: 30-NOV-05
ESCONDIDO, CA 92029 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CP BRACKET SYSTEM
DENTSPLY INTERNATIONAL 510(k) NO: K052370(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 WEST PHILADELPHIA ST. SE DECISION MADE: 01-NOV-05
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISTADENT AT COMPLETE, MODEL 3.1
DENTSPLY INTL., INC. 510(k) NO: K053010(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
SUSQUEHANNA COMMERCE CENTER SE DECISION MADE: 22-NOV-05
221W PHILADELPHIA ST. SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS
DENVER BIOMEDICAL, INC. 510(k) NO: K051711(TRADITIONAL)
ATTN: NANCY SAUER PHONE NO : 303-526-7402
433 PARK POINT DR. SUITE 140 SE DECISION MADE: 15-NOV-05
GOLDEN, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY CMW 1 GENTAMICIN BONE CEMENT
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K053002(SPECIAL)
ATTN: NATALIE S HECK PHONE NO : 574-267-8143
700 ORTHOPAEDIC DR. SE DECISION MADE: 22-NOV-05
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DEPUY CMW 1, 2 AND 3 BONE CEMENTS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K053003(SPECIAL)
ATTN: NATALIE S HECK PHONE NO : 574-267-8143
700 ORTHOPAEDIC DR. SE DECISION MADE: 22-NOV-05
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91
DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K051757(TRADITIONAL)
ATTN: PENNY WHITE PHONE NO : 902 566 1396
16 MCCARVILLE ST. SE DECISION MADE: 10-NOV-05
CHARLOTTETOWN, CANADA C1E 2A6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY ALPHA
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K051658(TRADITIONAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 16-NOV-05
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVERFIL
DUNIA PERWIRA MANUFACTURING SDN. B510(k) NO: K053114(TRADITIONAL)
ATTN: NARESH SANCHANA PHONE NO : 603 865 66005
BLOCK G, UPM-MTDC TECHNOLOGY SE DECISION MADE: 15-NOV-05
CENTER ONE, LEBUH SILIKON 510(k) STATEMENT
UPM SERDANG, SELANGOR, MALAYSIA 43THIRD PARTY REVIEW
DEVICE: DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 49
DYNAREX CORP. 510(k) NO: K052314(TRADITIONAL)
ATTN: JAMES HURLMAN PHONE NO : 845-365-8200
10 GLENSHAW ST. SE DECISION MADE: 09-NOV-05
ORANGEBURG, NY 10962 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CR-PRO
ERADLINK, INC. 510(k) NO: K052938(TRADITIONAL)
ATTN: ALBERT KOUBA PHONE NO : 310-373-5673
22750 HAWTHORNE BLVD. SE DECISION MADE: 17-NOV-05
TORRANCE, CA 90505-3664 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GYNECARE TVT SECUR SYSTEM
ETHICON, INC. 510(k) NO: K052401(TRADITIONAL)
ATTN: PATRICIA M HOJNOSKI PHONE NO : 908-218-2893
P.O BOX 151, ROUTE 22 WEST SE DECISION MADE: 28-NOV-05
SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABSOLUTE AMERICA
EURODENT S.P.A. 510(k) NO: K050571(ABBREVIATED)
ATTN: AVI POLITI PHONE NO : 201-386-0004
79 HUDSON STREET SE DECISION MADE: 02-NOV-05
HOBOKEN, NJ 07030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIESLAB CAP MPO-ANCA
EURODIAGNOSTICA 510(k) NO: K051455(TRADITIONAL)
ATTN: WILLIAM L BOTELER JR. PHONE NO : 301-695-7920
1306 BAILES LANE, SUITE F SE DECISION MADE: 23-NOV-05
FREDERICK, MD 21701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIESLAB CAP PR-3 ANCA
EURODIAGNOSTICA 510(k) NO: K051458(TRADITIONAL)
ATTN: WILLIAM L BOTELER JR. PHONE NO : 301-695-7920
1306 BAILES LANE, SUITE F SE DECISION MADE: 22-NOV-05
FREDERICK, MD 21701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVENFLO ELAN BREAST PUMP
EVENFLO COMPANY, INC. 510(k) NO: K052909(TRADITIONAL)
ATTN: THOMAS A SPARNO PHONE NO : 937-415-3211
707 CROSSROADS COURT SE DECISION MADE: 01-NOV-05
VANDALIA, OH 45377 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
EXACTECH, INC. 510(k) NO: K050398(SPECIAL)
ATTN: LISA SIMPSON PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 18-NOV-05
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA
GALIL MEDICAL LTD. 510(k) NO: K052530(TRADITIONAL)
ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 18-NOV-05
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMO
GAMBRO RENAL PRODUCTS 510(k) NO: K052253(SPECIAL)
ATTN: FEI LAW PHONE NO : 386-274-2811
1845 MASON AVE. SE DECISION MADE: 02-NOV-05
DAYTONA BEACH, FL 32117-5102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM
GE HEALTHCARE 510(k) NO: K052756(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 01-NOV-05
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 INTERFACE MODULE E-INT
GE HEALTHCARE 510(k) NO: K052880(SPECIAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 02-NOV-05
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACC
GE HEALTHCARE 510(k) NO: K052977(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 22-NOV-05
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTAGE WORKSTATION 4.3.
GE HEALTHCARE 510(k) NO: K052995(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 08-NOV-05
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM
GE HEALTHCARE TECHNOLOGIES 510(k) NO: K051734(TRADITIONAL)
ATTN: RAJ KASBEKAR PHONE NO : 978-552-5200
439 SOUTH UNION STREET, 3RD FL SE DECISION MADE: 23-NOV-05
LAWRENCE, MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OZONE GENERATOR
GE INFRASTRUCTURE WATER & PROCESS 510(k) NO: K043207(TRADITIONAL)
ATTN: CHARLENE NASH PHONE NO : 952-988-6359
5951 CLEARWATER DRIVE SE DECISION MADE: 04-NOV-05
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
GE MEDICAL SYSTEMS 510(k) NO: K053009(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3200 N. GRANDVIEW BLVD. SE DECISION MADE: 17-NOV-05
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE 1.5T SIGNA HDE MR SYSTEM
GE MEDICAL SYSTEMS, LLC 510(k) NO: K052978(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3200 N. GRANDVIEW BLVD. SE DECISION MADE: 09-NOV-05
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE DEFINIUM AMX 700, MODEL AMX 700
GENERAL ELECTRIC MEDICAL SYSTEMS 510(k) NO: K052897(SPECIAL)
ATTN: MARK STAUFFER PHONE NO : 262-544-3217
P.O. BOX 414 SE DECISION MADE: 08-NOV-05
MILWAUKEE, WI 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF
GENESEE BIOMEDICAL, INC. 510(k) NO: K052565(SPECIAL)
ATTN: JOHN T. M. WRIGHT PHONE NO : 303-777-3000
1308 SOUTH JASON ST. SE DECISION MADE: 17-NOV-05
DENVER, CO 80223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC
GENESEE BIOMEDICAL, INC. 510(k) NO: K052899(SPECIAL)
ATTN: JOHN T.M. WRIGHT PHONE NO : 303-777-3000
1308 SOUTH JASON ST. SE DECISION MADE: 17-NOV-05
DENVER, CO 80223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASSISTO ARM SYSTEMS
GEOMED MEDIZIN-TECHNIK GMBH & CO. 510(k) NO: K052745(TRADITIONAL)
ATTN: ANGELIKA SCHERP PHONE NO : +31 204 289591
AMSTEL 320-I SE DECISION MADE: 23-NOV-05
AMSTERDAM, NETHERLANDS 1017AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTERNAL FIXATION
GEXFIX USA INC. 510(k) NO: K052605(TRADITIONAL)
ATTN: LUCIO IMPROTA PHONE NO : 561-443-3321
1200 CLINT MOORE RD., STE. 1 SE DECISION MADE: 10-NOV-05
BOCA RATON, FL 33487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RBK PATELLA FEMORAL KNEE
GLOBAL ORTHOPAEDIC TECHNOLOGY, USA510(k) NO: K050473(TRADITIONAL)
ATTN: CARL KNOBLOCH PHONE NO : 407-977-8609
5349 RED LEAF COURT SE DECISION MADE: 14-NOV-05
OVIEDO, FL 32765-5018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K050024(TRADITIONAL)
ATTN: HOWARD K MANN PHONE NO : 215-369-3785
8903 SPRUCE MILL DRIVE SE DECISION MADE: 17-NOV-05
YARDLEY, PA 19087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR
GYRUS MEDICAL, INC. 510(k) NO: K050550(TRADITIONAL)
ATTN: MARK JENSEN PHONE NO : 763-416-3005
6655 WEDGWOOD ROAD, SUITE 160 SE DECISION MADE: 09-NOV-05
MAPLE GROVE, MN 55311-3602 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM
HAEMONETICS CORP. 510(k) NO: K053000(SPECIAL)
ATTN: GABRIEL J MURACA PHONE NO : 781-356-9553
400 WOOD ROAD SE DECISION MADE: 21-NOV-05
BRAINTREE, MA 02184-9114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND O
HOSPIRA, INC. 510(k) NO: K052722(SPECIAL)
ATTN: THOMAS KOZMA PHONE NO : 224-212-4803
275 NORTH FIELD DR. SE DECISION MADE: 02-NOV-05
LAKE FOREST, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K053038(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DR. SE DECISION MADE: 22-NOV-05
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMB
HYPHEN BIOMED 510(k) NO: K043007(TRADITIONAL)
ATTN: OLA ANDERSON PHONE NO : 513-770-1993
6560 GOVE CT. SE DECISION MADE: 07-NOV-05
MASON, OH 45040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLO
I-FLOW CORP. 510(k) NO: K051401(TRADITIONAL)
ATTN: SHANE NOEHRE PHONE NO : 949-206-2700
20202 WINDROW DR. SE DECISION MADE: 30-NOV-05
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACETYLCHOLINE RECEPTOR AB (ARAB)RRA
IBL-HAMBURG GMBH 510(k) NO: K051144(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570-620-0198
150 CHERRY LANE RD. SE DECISION MADE: 18-NOV-05
EAST STROUDSBURG, PA 18301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JBAIDS ANTHRAC DETECTION SYSTEM
IDAHO TECHNOLOGY, INC. 510(k) NO: K051713(TRADITIONAL)
ATTN: BETH LINGENFELTER PHONE NO : 801-736-6354
390 WAKARA WAY SE DECISION MADE: 18-NOV-05
SALT LAKE CITY, UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGECAST PACS
IDX SYSTEMS CORP. 510(k) NO: K052618(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 17-NOV-05
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS
IMMUNALYSIS CORPORATION 510(k) NO: K051578(TRADITIONAL)
ATTN: MICHAEL VINCENT PHONE NO : 909-482-0840
829 TOWNE CENTER DR. SE DECISION MADE: 18-NOV-05
POMONA, CA 91767 510(k) STATEMENT
DEVICE: GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
IMPLANTECH ASSOCIATES INC. 510(k) NO: K052504(TRADITIONAL)
ATTN: STEPHEN MEADE PHONE NO : 805-339-9415
6025 NICOLLE ST., SUITE B SE DECISION MADE: 04-NOV-05
VENTURA, CA 93003 510(k) STATEMENT
DEVICE: CALF IMPLANT, MODEL EC17-X
IMPLANTECH ASSOCIATES INC. 510(k) NO: K052505(TRADITIONAL)
ATTN: STEPHEN MEADE PHONE NO : 805-339-9415
6025 NICOLLE ST., SUITE B SE DECISION MADE: 04-NOV-05
VENTURA, CA 93003 510(k) STATEMENT
DEVICE: ILUMA ORTHOCAT/DENTALCAT
IMTEC CORP. 510(k) NO: K053046(ABBREVIATED)
ATTN: J. BRAD VANCE PHONE NO : 580-223-4456
2401 NORTH COMMERCE SE DECISION MADE: 08-NOV-05
ARDMORE, OK 73401 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: ONE STEP FSH MENOPAUSAL TEST
IND DIAGNOSTIC INC. 510(k) NO: K052662(TRADITIONAL)
ATTN: JASON PENG PHONE NO : 604 522 1619
1629 FOSTERS WAY SE DECISION MADE: 30-NOV-05
DELTA, B.C., CANADA V3M 6S7 510(k) STATEMENT
DEVICE: INFINITT G3 PACS
INFINITT CO., LTD. 510(k) NO: K052545(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 08-NOV-05
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM
INION LTD. 510(k) NO: K051821(TRADITIONAL)
ATTN: HANNA MARTTILA PHONE NO : 358 3 2306600
LAAKARINKATU 2 SE DECISION MADE: 25-NOV-05
TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE
INION OY 510(k) NO: K052624(TRADITIONAL)
ATTN: HANNA MARTTILA PHONE NO : 358 3 2306600
LAAKARINKATU 2 SE DECISION MADE: 16-NOV-05
TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IUI CATHETER, MODEL 9057
INNTEC, INC. 510(k) NO: K052059(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 22-NOV-05
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INO THERAPEUTICS INOBLENDER, MODEL 10004
INO THERAPEUTICS 510(k) NO: K052663(SPECIAL)
ATTN: FREDERICK MONTGOMERY PHONE NO : 608-831-4401
7601-B MURPHY DRIVE SE DECISION MADE: 04-NOV-05
MIDDLETON, WI 53562 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA LITE CCP3 IGG ELISA
INOVA DIAGNOSTICS, INC. 510(k) NO: K052264(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 858-586-9900
9900 OLD GROVE RD. SE DECISION MADE: 23-NOV-05
SAN DIEGO, CA 92131-1638 510(k) STATEMENT
DEVICE: EXTENDED MEASUREMENTS SYSTEM
INOVISE MEDICAL, INC. 510(k) NO: K051450(TRADITIONAL)
ATTN: STEVE C HESLER PHONE NO : 503-431-3837
10565 SW NIMBUS AVE. SE DECISION MADE: 10-NOV-05
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
PORTLAND, OR 97223
DEVICE: MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2
INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K053045(SPECIAL)
ATTN: DONNA WALLACE PHONE NO : 609-936-2397
311 ENTERPRISE DR. SE DECISION MADE: 21-NOV-05
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMC SURGICAL DRAPES
INTERNATIONAL MEDSURG CONNECTION, 510(k) NO: K052169(TRADITIONAL)
ATTN: MANNY GUPTA PHONE NO : 847-619-9926
935 NORTH PLUM GROVE RD. SE DECISION MADE: 17-NOV-05
SUITE F 510(k) SUMMARY AVAILABLE FROM FDA
SCHAUMBURG, IL 60173
DEVICE: IMC SURGICAL GOWNS
INTL. MEDSURG CONNECTION, INC. 510(k) NO: K052550(TRADITIONAL)
ATTN: MANNY GUPTA PHONE NO : 847-619-9926
935 N. PLUM GROVE RD. STE. F SE DECISION MADE: 17-NOV-05
SCHAUMBURG, IL 60173-4770 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
INVATEC INNOVATIVE TECHNOLOGIES, S510(k) NO: K052791(SPECIAL)
ATTN: STEPHANIE ROBINSON PHONE NO : 763-398-7036
4600 NATHAN LANE NORTH SE DECISION MADE: 04-NOV-05
PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE
INVIVO CORP. 510(k) NO: K052704(TRADITIONAL)
ATTN: THOMAS E TYNES PHONE NO : 262-524-1402
N27 W23676 PAUL ROAD SE DECISION MADE: 03-NOV-05
PEWAUKEE, WI 53072 510(k) STATEMENT
DEVICE: MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS
INVIVO CORPORATION 510(k) NO: K053017(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
N27 W23676 PAUL RD. SE DECISION MADE: 16-NOV-05
PEWAUKEE, WI 53072 510(k) STATEMENT
DEVICE: J. MORITA AZ ULTRASONIC SYSTEM
J. MORITA USA, INC. 510(k) NO: K053030(TRADITIONAL)
ATTN: HOWARD ROWE PHONE NO : 949-465-1034
9 MASON SE DECISION MADE: 07-NOV-05
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: REGIUS MODEL 170 DIRECT DIGITIZER
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K051998(TRADITIONAL)
ATTN: MASAFUMI SAITO PHONE NO : 81 426 609607
2970 ISHIKAWA-MACHI SE DECISION MADE: 03-NOV-05
HACHIOJI-SHI, TOKYO, JAPAN 192-850510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K052095(TRADITIONAL)
ATTN: MASAFUMI SAITO PHONE NO : 814 266 09607
2970 ISHIKAWA-MACHI SE DECISION MADE: 03-NOV-05
HACHIOJI-SHI, TOKYO, JAPAN 192-850510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
KONTRON MEDICAL SYSTEMS SAS 510(k) NO: K053084(TRADITIONAL)
ATTN: LARRY WALKER PHONE NO : 800-365-6668
17725 N.E. 65TH STREET SE DECISION MADE: 16-NOV-05
BLDG. C 510(k) SUMMARY AVAILABLE FROM FDA
REDMOND, WA 98052-4911 THIRD PARTY REVIEW
DEVICE: KOWA GENESIS-D HAND-HELD RETINAL CAMERA
KOWA CO. LTD. 510(k) NO: K050271(TRADITIONAL)
ATTN: SATOHIKO TAKANISHI PHONE NO : 81 3 32797329
4-14, NIHONBASHI-HONCHO SE DECISION MADE: 03-NOV-05
3-CHOME 510(k) SUMMARY AVAILABLE FROM FDA
CHUO-KU, TOKYO, JAPAN 103-8433 THIRD PARTY REVIEW
DEVICE: KOWA NONMYD 7, KOWA NONMYD A-D
KOWA CO. LTD. 510(k) NO: K053026(TRADITIONAL)
ATTN: SATOHIKO TAKANASHI PHONE NO : +81 332 797329
4-14, NIHONBASHI-HONCHO SE DECISION MADE: 10-NOV-05
3-CHOME 510(k) SUMMARY AVAILABLE FROM FDA
CHUO-KU, TOKYO, JAPAN 103-8433 THIRD PARTY REVIEW
DEVICE: KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT
KRONUS MARKET DEVELOPMENT ASSOCIAT510(k) NO: K051061(TRADITIONAL)
ATTN: MEATHER VIELE PHONE NO : 208-377-4800
12554 WEST BRIDGER ST. SE DECISION MADE: 04-NOV-05
SUITE 108 510(k) STATEMENT
BOISE, ID 83713
DEVICE: GLAID OCULAR ELECTROPHYSIOLOGY DEVICE
LACE ELECTRONICA S.R.L. 510(k) NO: K043367(TRADITIONAL)
ATTN: IAN P GORDON PHONE NO : 727-797-4727
2454 MCMULLEN BOOTH RD. SE DECISION MADE: 17-NOV-05
SUITE 427 510(k) SUMMARY AVAILABLE FROM FDA
CLEARWATER, FL 33759
DEVICE: IMAGE STAR II
LAKESHORE TECHNOLOGIES INC. 510(k) NO: K052610(TRADITIONAL)
ATTN: JACK RACE PHONE NO : 315-699-2975
7536 MURRAY DR. SE DECISION MADE: 30-NOV-05
CICERO, NY 13039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIBERTY GLUCOSE CONTROL, MODEL 2120031
LIBERTY HEALTHCARE GROUP, INC. 510(k) NO: K052980(TRADITIONAL)
ATTN: JOJN C GORMLEY PHONE NO : 830-372-1991
940 CROSSROADS BLVD. SE DECISION MADE: 30-NOV-05
SEGUIN, TX 78155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIUM DBM GEL AND PUTTY
LIFENET 510(k) NO: K053098(TRADITIONAL)
ATTN: DAVID KLEMENTOWSKI PHONE NO : 757-464-4761
5809 WARD CT. SE DECISION MADE: 28-NOV-05
VIRGINIA BEACH, VA 23455 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES
LUMENIS, INC. 510(k) NO: K052526(TRADITIONAL)
ATTN: KAREN L BAKER PHONE NO : 408-764-3603
2400 CONDENSA ST. SE DECISION MADE: 15-NOV-05
SANTA CLARA, CA 95051-0901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URYXXON 200 URINE ANALYZER
MACHEREY-NAGEL GMBH & CO., KG. 510(k) NO: K051034(TRADITIONAL)
ATTN: EDUARDO MARCH PHONE NO : 301-828-3120
7361 CALHOUN PLACE, SUITE 500 SE DECISION MADE: 22-NOV-05
ROCKVILLE, MD 20855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS)
MAKO SURGICAL CORP. 510(k) NO: K052851(SPECIAL)
ATTN: WILLIAM F TAPIA PHONE NO : 954-927-2044
2901 SIMMS STREET SE DECISION MADE: 18-NOV-05
HOLLYWOOD, FL 33020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE
MANAN MEDICAL PRODUCTS, INC. 510(k) NO: K052802(SPECIAL)
ATTN: NICOHL R WILDING PHONE NO : 800-424-6779
241 WEST PALATINE RD. SE DECISION MADE: 01-NOV-05
WHEELING, IL 60090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JOSTRA HLM TUBING SET
MAQUET CARDIOPULMONARY AG 510(k) NO: K053025(TRADITIONAL)
ATTN: KATHLEEN JOHNSON PHONE NO : 641-472-0775
P.O. BOX 2042 SE DECISION MADE: 10-NOV-05
FAIRFIELD, IA 52556 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MEDCOMP SPLIT CATH II
MEDCOMP 510(k) NO: K051280(TRADITIONAL)
ATTN: JEAN CALLOW PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 30-NOV-05
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDITECH MODEL ABPM-04
MEDITECH KFT. 510(k) NO: K051149(TRADITIONAL)
ATTN: BENNY ARAZY PHONE NO : 972 4 9940337
INDUSTRIAL PARK 13 SE DECISION MADE: 18-NOV-05
MIZPE AVIV 510(k) STATEMENT
M.P. MISGAV, ISRAEL 20187
DEVICE: MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COI
MEDRAD, INC. 510(k) NO: K052827(SPECIAL)
ATTN: LISA A EWING PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 01-NOV-05
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE
MEDRAD, INC. 510(k) NO: K053042(SPECIAL)
ATTN: LISA A EWING PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 17-NOV-05
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UVBIOTEK MODELS 3200B AND 4000B
MEDTEK LIGHTING CORPORATION 510(k) NO: K051330(TRADITIONAL)
ATTN: ROBERT T WAGNER PHONE NO : 727-471-0173
2840 SCHERER DRIVE N. SE DECISION MADE: 18-NOV-05
SAINT PETERSBURG, FL 33716 510(k) STATEMENT
DEVICE: MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRES
MEDTRADE PRODUCTS LTD. 510(k) NO: K051082(TRADITIONAL)
ATTN: JONATHAN D RANFIELD PHONE NO : 440 127 0500019
ELECTRA HOUSE SE DECISION MADE: 08-NOV-05
CREWE BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA
CREWE, CHESHIRE, UNITED KINGDOM CW1 6GL
DEVICE: CG FUTURE ANNULOPLASTY BAND
MEDTRONIC HEART VALVES 510(k) NO: K052860(SPECIAL)
ATTN: JULIE SHERMAN PHONE NO : 763-514-2876
8299 CENTRAL AVE., N.E. SE DECISION MADE: 10-NOV-05
M.S. P108 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55432-3576
DEVICE: MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MM
MEDTRONIC MINIMED 510(k) NO: K052431(TRADITIONAL)
ATTN: JODIE ROGERS PHONE NO : 818-576-5708
18000 DEVONSHIRE ST. SE DECISION MADE: 29-NOV-05
NORTHRIDGE, CA 91325-1219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-
MEDTRONIC MINIMED 510(k) NO: K052432(TRADITIONAL)
ATTN: JODIE ROGERS PHONE NO : 818-576-5708
18000 DEVONSHIRE ST. SE DECISION MADE: 29-NOV-05
NORTHRIDGE, CA 91325-1219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K052524(SPECIAL)
ATTN: BRUCE BACKLUND PHONE NO : 763-391-9000
7611 NORTHLAND DR. SE DECISION MADE: 22-NOV-05
MINNEAPOLIS, MN 55038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VERTE-STACK SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K052931(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
PYRAMID PLACE SE DECISION MADE: 16-NOV-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934
MEDTRONIC, INC. 510(k) NO: K052413(TRADITIONAL)
ATTN: JULIE GOODE PHONE NO : 763-514-9670
4000 LEXINGTON AVE. N SE DECISION MADE: 17-NOV-05
SHOREVIEW, MN 55126-2983 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PIONEER U601 SERIES ASPIRATOR
MERITS HEALTH PRODUCTS CO., LTD. 510(k) NO: K052650(ABBREVIATED)
ATTN: STEVE CHAO PHONE NO : 886 4 23594985
9, ROAD 36 SE DECISION MADE: 04-NOV-05
TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN) 407
DEVICE: SKELITE RESORBABLE CEMENT RESTRICTOR
MILLENIUM BIOLOGIX, INC. 510(k) NO: K051836(TRADITIONAL)
ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830
1129 BLOOMFIELD AVE. SE DECISION MADE: 21-NOV-05
WEST CALDWELL, NJ 07006 510(k) STATEMENT
DEVICE: POLY SILOXANE IMPRESSION MATERIAL
MILLENNIUM DENTAL INTERNATIONAL, I510(k) NO: K053018(TRADITIONAL)
ATTN: JEANETTE SMITH PHONE NO : 519 641 3066
1980 HYDE PARK SE DECISION MADE: 08-NOV-05
LONDON, ONTARIO, CANADA N6H 5L9 510(k) STATEMENT
DEVICE: MILTEX LIGATING CLIP
MILTEX, INC. 510(k) NO: K052018(TRADITIONAL)
ATTN: CHARLES WEAVER PHONE NO : 717-840-9335
589 DAVIES DRIVE SE DECISION MADE: 04-NOV-05
YORK, PA 17402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY
MISONIX, INC. 510(k) NO: K052702(TRADITIONAL)
ATTN: RONALD R MANNA PHONE NO : 631-694-9555
1938 NEW HIGHWAY SE DECISION MADE: 21-NOV-05
FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Y2K2 ENTERNAL TUBE FLUID FILTER
MOSS MEDICAL PRODUCTS 510(k) NO: K051206(TRADITIONAL)
ATTN: GERALD MOSS PHONE NO : 516-674-0904
4049 NY 150 SE DECISION MADE: 02-NOV-05
WEST SAND LAKE, NY 12196 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SOPRANO HAIR REMOVAL DIODE LASER
MSQ (M2) LTD. 510(k) NO: K052874(SPECIAL)
ATTN: TATIANA EPSTEIN PHONE NO : 972 462 75357
7 HAESHEL ST. SE DECISION MADE: 22-NOV-05
INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
CAESAREA, ISRAEL 38900
DEVICE: BE-CERTAIN PREGNANCY TEST
NATUREPLEX, LLC 510(k) NO: K051963(TRADITIONAL)
ATTN: VICTOR J SANTOS PHONE NO : 901-327-4550
3791 AIRPARK ST. SE DECISION MADE: 23-NOV-05
MEMPHIS, TN 38118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K052186(SPECIAL)
ATTN: PATRICK GARVEY PHONE NO : 925-463-4479
4280 HACIENDA DR. SE DECISION MADE: 10-NOV-05
PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIPRO HYPODERMIC NEEDLE
NIPRO MEDICAL CORP. 510(k) NO: K052474(TRADITIONAL)
ATTN: KAELYN B HADLEY PHONE NO : 859-224-8256
1384 COPPERFIELD COURT SE DECISION MADE: 10-NOV-05
LEXINGTON, KY 40514-1268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WRISTOX MODEL 3100 PULSE OXIMETER
NONIN MEDICAL, INC. 510(k) NO: K052829(TRADITIONAL)
ATTN: LORI ROTH PHONE NO : 763-577-3093
13700 1ST AVE. NORTH SE DECISION MADE: 10-NOV-05
PLYMOUTH, MN 55441-5443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160
NORAS RONTGEN-UND MEDIZINTECHNIK G510(k) NO: K052987(SPECIAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 08-NOV-05
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPER PORCELAIN EX-3 PRESS
NORITAKE CO., INC. 510(k) NO: K052304(TRADITIONAL)
ATTN: IVAN J WASSERMAN PHONE NO : 202-342-8400
3050 K STREET, NW, STE 400 SE DECISION MADE: 23-NOV-05
WASHINGTON, DC 20007 510(k) STATEMENT
DEVICE: NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE
NORTH COAST MEDICAL, INC. 510(k) NO: K052019(TRADITIONAL)
ATTN: TARHAN KAYIHAN PHONE NO : 408-776-5000
18305 SUTTER BLVD. SE DECISION MADE: 04-NOV-05
MORGAN HILL, CA 95037-2845 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVABONE-BIOACTIVE SYNTHETIC GRAFT
NOVABONE PRODUCTS, LLC 510(k) NO: K052494(TRADITIONAL)
ATTN: DAVID M GAISSER PHONE NO : 386-462-7660
13709 PROGRESS BLVD., #33 SE DECISION MADE: 03-NOV-05
ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMIT SLEEVE
NUCLETRON CORPORATION 510(k) NO: K052228(TRADITIONAL)
ATTN: LISA DIMMICK PHONE NO : 410-872-4435
8671 ROBERT FULTON DR. SE DECISION MADE: 09-NOV-05
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K051886(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DR. SE DECISION MADE: 14-NOV-05
MELVILLE, NY 11747-9058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTADERM ANTIMICROBIAL WOUND DRESSING
ORGANOGENESIS, INC. 510(k) NO: K051647(TRADITIONAL)
ATTN: PATRICK BILBO PHONE NO : 781-401-1155
150 DAN RD. SE DECISION MADE: 08-NOV-05
CANTON, MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAMON 3 MODIFIED
ORMCO CORP. 510(k) NO: K052477(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 949-255-8766
1717 WEST COLLINS AVENUE SE DECISION MADE: 30-NOV-05
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRAFTON PLUS DBM PASTE
OSTEOTECH, INC. 510(k) NO: K042707(TRADITIONAL)
ATTN: CHRISTOPHER TALBOT PHONE NO : 732-542-2800
51 JAMES WAY SE DECISION MADE: 30-NOV-05
EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRAFTON PLUS DBM PASTE
OSTEOTECH, INC. 510(k) NO: K043048(TRADITIONAL)
ATTN: CHRISTOPHER TALBOT PHONE NO : 732-542-2800
51 JAMES WAY SE DECISION MADE: 23-NOV-05
EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXI-LITE, MODEL FL-V1.2
PERFORMANCE HYPERBARICS 510(k) NO: K051759(TRADITIONAL)
ATTN: SPENCER FELDMAN PHONE NO : 808-573-8166
2599 A OLINDA ROAD SE DECISION MADE: 17-NOV-05
MAKAWAO, HI 96768 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLI
PHILIPS MEDICAL SYSTEMS 510(k) NO: K052961(SPECIAL)
ATTN: TAPAN D SHAH PHONE NO : 978-659-7681
3000 MINUTEMAN RD. SE DECISION MADE: 18-NOV-05
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K052377(ABBREVIATED)
ATTN: EGON PFEIL PHONE NO : 497 031 4631926
HEWLETT-PACKARD STR.2 SE DECISION MADE: 17-NOV-05
BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K052801(SPECIAL)
ATTN: HAUKE SCHIK PHONE NO : 49 703 14632031
HEWLETT-PACKARD STR.2 SE DECISION MADE: 02-NOV-05
BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIEZOSURGERY
PIEZOSURGERY SRL 510(k) NO: K052518(TRADITIONAL)
ATTN: MARIA E DONAWA PHONE NO : +39 065 782665
PIAZZA ALBANIA 10 SE DECISION MADE: 16-NOV-05
ROME, ITALY 00153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PACP SYSTEM
PIONEER SURGICAL TECHNOLOGY 510(k) NO: K053053(SPECIAL)
ATTN: JONATHAN GILBERT PHONE NO : 906-226-4812
375 RIVER PARK CIRCLE SE DECISION MADE: 16-NOV-05
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ
POLYGANICS BV 510(k) NO: K052099(TRADITIONAL)
ATTN: JAN NIEUWENHUIS PHONE NO : 315 058 86588
L.J. ZIELSTRAWEG 1 SE DECISION MADE: 21-NOV-05
GRONINGEN, NETHERLANDS 9713-GX 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOJET XPEEDIOR 120 CATHETER
POSSIS MEDICAL, INC. 510(k) NO: K052256(TRADITIONAL)
ATTN: MARK STENOIEN PHONE NO : 763-780-4555
9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 10-NOV-05
MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOAD
POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K052910(SPECIAL)
ATTN: BARBARA J WHITMAN PHONE NO : 267-775-8151
2021 CABOT BLVD. SE DECISION MADE: 07-NOV-05
LANGHORNE, PA 19047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEDIATRIC FEEDING TUBE
PROMEDIC, INC. 510(k) NO: K052903(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 WEST WATERVIEW CT. SE DECISION MADE: 09-NOV-05
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE
PT. SHAMROCK MANUFACTURING CORP. 510(k) NO: K052709(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 909-591-8855
5445 DANIELS STREET SE DECISION MADE: 08-NOV-05
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOKO LEGEND
PULMONARY DATA SERVICES, INC. 510(k) NO: K051572(SPECIAL)
ATTN: DONALD HENTON PHONE NO : 303-666-5555
908 MAIN STREET SE DECISION MADE: 17-NOV-05
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)
QUEST DIAGNOSTICS, INC. 510(k) NO: K051161(TRADITIONAL)
ATTN: JAMES BOURLAND PHONE NO : 702-733-3769
4230 BURNHAM AVE. SE DECISION MADE: 22-NOV-05
LAS VEGAS, NV 89119-5410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUILL NONABSORBABLE NYLON BARBED SUTURE
QUILL MEDICAL, INC. 510(k) NO: K052900(ABBREVIATED)
ATTN: LOIS V SMART PHONE NO : 919-806-1961
2505 MERIDIAN PARKWAY SE DECISION MADE: 28-NOV-05
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
RESEARCH TRIANGLE PARK, NC 27713
DEVICE: RPS ADENO DETECTOR
RAPID PATHOGEN SCREENING 510(k) NO: K052092(TRADITIONAL)
ATTN: ROBERT SAMBURSKY PHONE NO : 215-300-2255
13946 WOOD DUCK CIRCLE SE DECISION MADE: 22-NOV-05
BRADENTON, FL 34202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRA
REFERENCE DIAGNOSTICS, INC. 510(k) NO: K052148(ABBREVIATED)
ATTN: JOSEPH LAWLOR PHONE NO : 781-276-9000
19 CROSBY DR. SUITE 30 SE DECISION MADE: 09-NOV-05
BEDFORD, MA 01730 510(k) STATEMENT
DEVICE: STERLING INTERFERENC SCREW HT
REGENERATION TECHNOLOGIES, INC. 510(k) NO: K052405(TRADITIONAL)
ATTN: CARRIE HARTILL PHONE NO : 386-418-8888
11621 RESEARCH CIR. SE DECISION MADE: 16-NOV-05
P.O. BOX 2650 510(k) SUMMARY AVAILABLE FROM FDA
ALACHUA, FL 32616-2650
DEVICE: OMNIPICC PI
RITA MEDICAL SYSTEMS, INC. 510(k) NO: K051102(TRADITIONAL)
ATTN: DAVID SMITH PHONE NO : 706-846-3126
1 HORIZON WAY SE DECISION MADE: 23-NOV-05
MANCHESTER, GA 31816 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK
ROCHE DIAGNOSTICS 510(k) NO: K053059(SPECIAL)
ATTN: RANDY JOHNSON PHONE NO : 317-521-3532
9115 HAGUE ROAD SE DECISION MADE: 28-NOV-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUBICOR MAGIC BREAST BIOPSY DEVICE
RUBICOR MEDICAL, INC. 510(k) NO: K053151(TRADITIONAL)
ATTN: ROBERT J CHIN PHONE NO : 650-593-5225
849 VETERANS BLVD. SE DECISION MADE: 18-NOV-05
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SAFERSLEEP SYSTEM
SAFER SLEEP LLC 510(k) NO: K050883(TRADITIONAL)
ATTN: STEVEN CHERNOFF PHONE NO : 425-861-8262
P.O. BOX 3515 SE DECISION MADE: 04-NOV-05
REDMOND, WA 98073-3515 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000
SANARUS MEDICAL, INC. 510(k) NO: K052861(SPECIAL)
ATTN: TRENA DEPEL PHONE NO : 925-460-5731
4696 WILLOW RD. SE DECISION MADE: 15-NOV-05
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAUFLON FLAT COLOURED LENS CASE
SAUFLON PHARMACEUTICALS, LTD. 510(k) NO: K052809(TRADITIONAL)
ATTN: AZITTA JADALIZADEH PHONE NO : 44 208 3224200
49-53 YORK ST. SE DECISION MADE: 02-NOV-05
TWICKENHAM, MIDDLESEX, UNITED KING510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60
SCIENCES FOR BIO MATERIALS 510(k) NO: K050407(TRADITIONAL)
ATTN: DENIS CLEMENT PHONE NO : 33 562 422101
ZI DU MONGE SE DECISION MADE: 04-NOV-05
LOURDES, FRANCE F65100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STELLA CERVICAL PLATE
SCIENT'X 510(k) NO: K052763(SPECIAL)
ATTN: J. D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 10-NOV-05
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABL80 FLEX ANALYZER
SENDX MEDICAL, INC. 510(k) NO: K051804(TRADITIONAL)
ATTN: DOREEN E MILFORD PHONE NO : 760-603-3401
1945 PALOMAR OAKS WAY SE DECISION MADE: 01-NOV-05
CARLSBAD, CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENTINEL UIBC LIQUID
SENTINEL CH. SRL 510(k) NO: K051111(TRADITIONAL)
ATTN: DAVIDE SPADA PHONE NO : 39 02 3455141
5 VIA PRINCIPE EUGENIO SE DECISION MADE: 17-NOV-05
MILANO, ITALY 20155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
SENTINEL CH. SRL 510(k) NO: K051114(TRADITIONAL)
ATTN: DAVIDE SPADA PHONE NO : 39 02 3455141
5 VIA PRINCIPE EUGENIO SE DECISION MADE: 25-NOV-05
MILANO, ITALY 20155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS
SERADYN INC. 510(k) NO: K051211(TRADITIONAL)
ATTN: JACK ROGERS PHONE NO : 317-610-3823
7998 GEORGETOWN RD. SE DECISION MADE: 18-NOV-05
SUITE 1000 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46268-5260
DEVICE: QMS AMIKACIN REAGENTS
SERADYN INC. 510(k) NO: K052815(TRADITIONAL)
ATTN: JACK ROGERS PHONE NO : 317-610-3823
7998 GEORGETOWN RD. SE DECISION MADE: 01-NOV-05
SUITE 1000 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46268-5260
DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, N
SHANGHAI ANTARES INDUSTRIES, INC. 510(k) NO: K052612(ABBREVIATED)
ATTN: JOHN LAI PHONE NO : 011 86 2157814213
259 YUSHU RD., SE DECISION MADE: 22-NOV-05
CANGQIAO TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA
SONGJIANG COUNTY, SHANGHAI, CHINA 201600
DEVICE: F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT
SHANGHAI FIMET MEDICAL INSTRUMENT 510(k) NO: K052470(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 01-NOV-05
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S.
SHIAN JIA MEEI ENTERPRISE CO., LTD510(k) NO: K052182(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 04-NOV-05
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VINTAGE ZR
SHOFU DENTAL CORP. 510(k) NO: K052033(TRADITIONAL)
ATTN: DAVID P MORAIS PHONE NO : 760-736-3277
1225 STONE DR. SE DECISION MADE: 18-NOV-05
SAN MARCOS, CA 92078 510(k) STATEMENT
DEVICE: SYNGO NEURO DSA CT
SIEMENS AG 510(k) NO: K053024(TRADITIONAL)
ATTN: RUEDIGER KOERNER PHONE NO : 499 191 189355
SIEMENSSTR. 1 SE DECISION MADE: 04-NOV-05
FORCHHEIM, GERMANY D-91301 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ACUSON CYPRESS ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K052331(TRADITIONAL)
ATTN: ISKRA MRAKOVIC PHONE NO : 650-694-5004
1230 SHOREBIRD WAY SE DECISION MADE: 10-NOV-05
P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393
DEVICE: SONOLINE G60 S ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K052894(SPECIAL)
ATTN: ISKRA MRAKOVIC PHONE NO : 650-694-5004
1230 SHOREBIRD WAY SE DECISION MADE: 23-NOV-05
P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393
DEVICE: KIMBA SPINAL IMPLANT
SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K052533(TRADITIONAL)
ATTN: TRACY L GRAY PHONE NO : 763-588-9873
4050 OLSON MEMORIAL HWY SE DECISION MADE: 03-NOV-05
SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55422
DEVICE: SBI AUTOFIX
SMALL BONE INNOVATIONS, LLC 510(k) NO: K052576(TRADITIONAL)
ATTN: DONALD GUTHNER PHONE NO : 212-583-0250
505 PARK AVE., 14TH FLOOR SE DECISION MADE: 07-NOV-05
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K050209(TRADITIONAL)
ATTN: JANICE HASELTON PHONE NO : 978-749-1494
150 MINUTEMAN RD. SE DECISION MADE: 23-NOV-05
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADD-MS 3 AMBULATORY INFUSION PUMP
SMITHS MEDICAL MD, INC. 510(k) NO: K051568(TRADITIONAL)
ATTN: MELANIE HESS PHONE NO : 651-628-7333
1265 GREY FOX RD. SE DECISION MADE: 17-NOV-05
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVOS SYSTEM
SOMANETICS CORP. 510(k) NO: K051274(TRADITIONAL)
ATTN: RONALD A WIDMAN PHONE NO : 248-689-3050
1653 EAST MAPLE RD. SE DECISION MADE: 04-NOV-05
TROY, MI 48083-4208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
SONOSITE,INC. 510(k) NO: K053069(TRADITIONAL)
ATTN: DAINA L GRAHAM PHONE NO : 425-951-1275
21919 30TH DRIVE SE. SE DECISION MADE: 16-NOV-05
BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: UNI-THREAD SPINAL SYSTEM
SPINE VISION, INC 510(k) NO: K052406(TRADITIONAL)
ATTN: LYNNETTE WHITAKER PHONE NO : 574-269-9776
3003 SUMMIT BLVD., SUITE 1400 SE DECISION MADE: 07-NOV-05
ATLANTA, GA 30319 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STIMUPLEX HNS-12, MODEL 4892098
STOCKERT GMBH 510(k) NO: K052313(ABBREVIATED)
ATTN: DOMINIKA SCHULER PHONE NO : +49 761 207160
BOETZINGER STRASSE 72 SE DECISION MADE: 17-NOV-05
FREIBURG, B-W, GERMANY D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER SPINE AVS ASL PEEK SPACER
STRYKER SPINE 510(k) NO: K051205(TRADITIONAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL CT. SE DECISION MADE: 04-NOV-05
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER SPINE TRIO SPINAL FIXATION SYSTEM
STRYKER SPINE 510(k) NO: K052971(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 16-NOV-05
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSA-LINK PORCELAIN BONDING SYSTEM
SULTAN CHEMISTS, INC. 510(k) NO: K052699(TRADITIONAL)
ATTN: CLARK SMITH PHONE NO : 201-871-1232
85 WEST FOREST AVE. SE DECISION MADE: 16-NOV-05
ENGLEWOOD, NJ 07631 510(k) STATEMENT
DEVICE: SUPERDIMENSION/BRONCHUS PREMIUM
SUPERDIMENSION, LTD. 510(k) NO: K052852(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 S SE DECISION MADE: 14-NOV-05
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE
SURGICAL SPECIALTIES CORP. 510(k) NO: K052437(TRADITIONAL)
ATTN: ELIZABETH LAZARO PHONE NO : 610-404-1000
100 DENNIS DR. SE DECISION MADE: 07-NOV-05
READING, PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LEN
SYNERGEYES 510(k) NO: K052675(TRADITIONAL)
ATTN: RICHARD E LIPPMAN PHONE NO : 240-683-3738
15825 SHADY GROVE ROAD SE DECISION MADE: 30-NOV-05
SUITE 30 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20850
DEVICE: POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE
SYNTEX HEALTHCARE PRODUCTS CO. LTD510(k) NO: K052877(TRADITIONAL)
ATTN: MICKY LIN PHONE NO : 909-591-7888
3973 SCHAEFER AVE. SE DECISION MADE: 08-NOV-05
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) SPHERICAL WASHERS
SYNTHES (USA) 510(k) NO: K052483(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-719-5861
1302 WRIGHTS LANE EAST SE DECISION MADE: 04-NOV-05
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, M
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K052872(TRADITIONAL)
ATTN: SHU-MEI WU PHONE NO : 886 266 358080
4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 23-NOV-05
SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIARDIA/CRYPTOSPORIDIUM CHEK
TECHLAB, INC. 510(k) NO: K051929(TRADITIONAL)
ATTN: DAVID M LYRLY PHONE NO : 540-953-1664
2001 KRAFT DR. SE DECISION MADE: 17-NOV-05
BLACKSBURG, VA 24060-6358 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYPTOSPORIDIUM II
TECHLAB, INC. 510(k) NO: K052932(SPECIAL)
ATTN: DAVID M LYERLY PHONE NO : 540-953-1664
2001 KRAFT DR. SE DECISION MADE: 04-NOV-05
BLACKSBURG, VA 24060-6358 510(k) STATEMENT
DEVICE: TEH LOONG POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
TEH LOONG CORP. 510(k) NO: K052636(TRADITIONAL)
ATTN: CHIEN LIN PHONE NO : 773-327-2054
2631, N. MAGNOLIA STREET SE DECISION MADE: 10-NOV-05
CHICAGO, IL 60614 510(k) STATEMENT
DEVICE: SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE
TERANG NUSA SDN BHD 510(k) NO: K052837(SPECIAL)
ATTN: CHIN GUAN LOW PHONE NO : +60 977 47171
1, JALAN 8, SE DECISION MADE: 21-NOV-05
PENGKALAN CHEPA 2 IND. ZONE 510(k) STATEMENT
KOTA BHARU, KELANTAN, MALAYSIA 16100
DEVICE: TERUMO MICRO TAPERED PEN NEEDLE
TERUMO MEDICAL CORP. 510(k) NO: K052561(TRADITIONAL)
ATTN: BARBARA SMITH PHONE NO : 410-392-7241
125 BLUE BALL RD. SE DECISION MADE: 23-NOV-05
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IGD DIAGNOSTIC TEST KITS
THE BINDING SITE LTD. 510(k) NO: K051299(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
2425 WEST OLYMPIC BOULEVARD SE DECISION MADE: 23-NOV-05
WEST TOWER, SUITE 4000 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TOR
THE LAGADO CORP. 510(k) NO: K052507(TRADITIONAL)
ATTN: JOHN M SZABOCSIK PHONE NO : 312-553-0828
203 NORTH WABASH AVENUE SE DECISION MADE: 02-NOV-05
SUITE 1200 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60601
DEVICE: TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS
TIARA MEDICAL SYSTEMS, INC. 510(k) NO: K051583(SPECIAL)
ATTN: GEOFFREY SLEEPER PHONE NO : 216-521-1220
14414 DETROIT AVE, SUITE 205 SE DECISION MADE: 04-NOV-05
LAKEWOOD, OH 44107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOPEZ TOTAL ANKLE REPLACEMENT
TOPEZ ORTHOPEDICS, INC 510(k) NO: K051023(TRADITIONAL)
ATTN: LEWIS WARD PHONE NO : 303-530-3279
4655 KIRKWOOD COURT SE DECISION MADE: 15-NOV-05
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCOMPASS SOFTWARE PACKAGE
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K053043(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 18-NOV-05
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY
USA INSTRUMENTS, INC. 510(k) NO: K052916(SPECIAL)
ATTN: ROBERT B SMITH PHONE NO : 330-995-8572
1515 DANNER DR. SE DECISION MADE: 09-NOV-05
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMINA 1600, 3300 AND 6600 SYSTEMS
USA LASER BIOTECH INC. 510(k) NO: K052814(TRADITIONAL)
ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433
12101 CULLEN BLVD., # A SE DECISION MADE: 30-NOV-05
HOUSTON, TX 77047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECLIPSE TREATMENT PLANNING SYSTEM
VARIAN MEDICAL SYSTEMS 510(k) NO: K050296(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 03-NOV-05
M/S E-110 510(k) SUMMARY AVAILABLE FROM FDA
PALO ALTO, CA 94304-1129
DEVICE: VISION (WITH OFF-LINE REVIEW)
VARIAN MEDICAL SYSTEMS 510(k) NO: K052391(SPECIAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 23-NOV-05
M/S E-110 510(k) SUMMARY AVAILABLE FROM FDA
PALO ALTO, CA 94304-1129
DEVICE: VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER
VASCULAR SOLUTIONS, INC. 510(k) NO: K052257(TRADITIONAL)
ATTN: SARA L COON PHONE NO : 763-656-4300
6464 SYCAMORE COURT SE DECISION MADE: 23-NOV-05
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THROMBIX 3X3 HEMOSTATIC PAD
VASCULAR SOLUTIONS, INC. 510(k) NO: K053054(SPECIAL)
ATTN: LINDA BUSKLEIN PHONE NO : 763-656-4217
6464 SYCAMORE COURT NORTH SE DECISION MADE: 23-NOV-05
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS
VERYAN MEDICAL LIMITED 510(k) NO: K051312(TRADITIONAL)
ATTN: JUDITH DANIELSON PHONE NO : 360-904-6512
1327 BLUEGRASS WAY SE DECISION MADE: 04-NOV-05
GAMBRILLS, MD 21054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-MIO MANUAL DRIVER
VIDACARE CORPORATION 510(k) NO: K052195(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 02-NOV-05
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-IO
VIDACARE CORPORATION 510(k) NO: K052408(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 17-NOV-05
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VILEX X-FIX
VILEX, INC. 510(k) NO: K052196(TRADITIONAL)
ATTN: ABRAHAM LAVI PHONE NO : 412-655-7550
345 OLD CURRY HOLLOW RD. SE DECISION MADE: 22-NOV-05
PLEASANT HILLS, PA 15236 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BETACONE HIP PROSTHESIS SYSTEM
WALDEMAR LINK GMBH & CO. KG 510(k) NO: K051826(TRADITIONAL)
ATTN: JANICE M HOGAN PHONE NO : 267-675-4600
1835 MARKET STREET SE DECISION MADE: 18-NOV-05
28TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
PHILADELPHIA, PA 19103
DEVICE: DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-90
WELCH ALLYN, INC. 510(k) NO: K052784(ABBREVIATED)
ATTN: CHRIS KLACZKY PHONE NO : 315-685-3694
4341 STATE ST. RD. SE DECISION MADE: 22-NOV-05
SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)
WELCH ALLYN, INC. 510(k) NO: K053027(SPECIAL)
ATTN: JOHN E SAWYER PHONE NO : 315-685-4571
4341 SOUTH STATE ST. RD. SE DECISION MADE: 22-NOV-05
P.O. BOX 220 510(k) SUMMARY AVAILABLE FROM FDA
SKANEATELES FALLS, NY 13153-0220
DEVICE: IGNITE BONE VOID FILLER KIT
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K052913(SPECIAL)
ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732
5677 AIRLINE RD. SE DECISION MADE: 07-NOV-05
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES
YTY INDUSTRY (MANJUNG) SDN. BHD. 510(k) NO: K052502(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 18-NOV-05
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER
ZERUSA LIMITED 510(k) NO: K052381(TRADITIONAL)
ATTN: OONAGH SWEENEY PHONE NO : 011 353 91863062
219-220 BUSINESS INNOVATION SE DECISION MADE: 21-NOV-05
CENTRE NUIG, NEWCASTLE RD 510(k) SUMMARY AVAILABLE FROM FDA
GALWAY, IRELAND
DEVICE: THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTE
ZIMMER TRABECULAR 510(k) NO: K052950(SPECIAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 16-NOV-05
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEEL
ZIMMER, INC. 510(k) NO: K052879(SPECIAL)
ATTN: BRANDON HIPSHER PHONE NO : 574-371-8083
P.O. BOX 708 SE DECISION MADE: 22-NOV-05
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 258
TOTAL WITH SUMMARIES 225
TOTAL WITH STATEMENTS 33
Updated December 5, 2005
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