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510(k)s Final Decisions Rendered for October 2000 |
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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-OCT-2000 THROUGH 31-OCT-2000
DEVICE: DMLC IV-ERGO
3D LINE USA, INC. 510(k) NO: K001163(TRADITIONAL)
ATTN: KAREN H RIGAMONTI PHONE NO : 410-580-1730
2807 OLD COURT ROAD SE DECISION MADE: 23-OCT-00
BALTIMORE, MD 21208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIROL EPIDURAL CATHETER
ABBOTT LABORATORIES 510(k) NO: K000886(TRADITIONAL)
ATTN: JILL N SACKETT PHONE NO : 847-937-4085
D-389, BLDG. AP30 SE DECISION MADE: 05-OCT-00
200 ABBOTT PARK ROAD 510(k) STATEMENT
ABBOTT PARK, IL 60064-6157
DEVICE: ABX MICROS CRP
ABX DIAGNOSTICS, INC. 510(k) NO: K002646(TRADITIONAL)
ATTN: BRUCE DAVIS PHONE NO : 297-842-7914
34 BUNSEN DR. SE DECISION MADE: 26-OCT-00
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103
ACRYMED, INC. 510(k) NO: K002909(SPECIAL)
ATTN: BRUCE GIBBINS PHONE NO : 503-624-9830
12232 SW GARDEN PLACE SE DECISION MADE: 13-OCT-00
PORTLAND, OR 97223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO YASARGIL ANEURYSM CLIPS
AESCULAP, INC. 510(k) NO: K002871(SPECIAL)
ATTN: JOYCE THOMAS PHONE NO : 610-231-0228
3773 EXECUTIVE CENTER PARKWAY SE DECISION MADE: 13-OCT-00
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M2376A DEVICELINK SYSTEM, MODEL M2376A
AGILENT TECHNOLOGIES, INC. 510(k) NO: K002967(SPECIAL)
ATTN: MIKE HUDON PHONE NO : 978-659-3173
3000 MINUTEMAN RD. SE DECISION MADE: 18-OCT-00
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M2376A DEVICELINK SYSTEM
AGILENT TECHNOLOGIES, INC. 510(k) NO: K003107(SPECIAL)
ATTN: MIKE HUDON PHONE NO : 978-659-3173
3000 MINUTEMAN RD. SE DECISION MADE: 19-OCT-00
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001
AIR FORCE INC 510(k) NO: K001493(TRADITIONAL)
ATTN: PIERO POLICICCHIO PHONE NO : 619-399-8511
933 BUTTERNUT DRIVE SE DECISION MADE: 25-OCT-00
HOLLAND, MI 49424 510(k) STATEMENT
DEVICE: DA VINCHI EEG AND EMG/EP SYSTEMS
AIRSEP CORP. 510(k) NO: K000963(TRADITIONAL)
ATTN: PETER WEISENBORN PHONE NO : 716-691-0202
290 CREEKSIDE DR. SE DECISION MADE: 20-OCT-00
BUFFALO, NY 14228-2070 510(k) STATEMENT
DEVICE: OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
ALCON UNIVERSAL, LTD. 510(k) NO: K002589(TRADITIONAL)
ATTN: MICHAEL E PFLEGER PHONE NO : 817-551-4877
6201 SOUTH FREEWAY SE DECISION MADE: 23-OCT-00
FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMS SPHINCTER 800 URINARY PROSTHESIS
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K002919(SPECIAL)
ATTN: ELSA A LINKE PHONE NO : 952-930-6309
10700 BREN RD., WEST SE DECISION MADE: 03-OCT-00
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
ANGIODYNAMICS, INC. 510(k) NO: K001578(SPECIAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 13-OCT-00
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR
ARISTA LATINDO INDUSTRIAL, LTD. P.510(k) NO: K002745(TRADITIONAL)
ATTN: LINGA SUMARTA PHONE NO : 622 166 20201/195
128 JALAN KYAI HAJI MUHAMMAD SE DECISION MADE: 12-OCT-00
MANSYUR 510(k) STATEMENT
JAKARTA BARAT, INDONESIA 11210
DEVICE: VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR
ARISTA LATINDO INDUSTRIAL, LTD. P.510(k) NO: K002746(TRADITIONAL)
ATTN: LINGA SUMARTA PHONE NO : 622 166 20201/195
128 JALAN KYAI HAJI MUHAMMAD SE DECISION MADE: 11-OCT-00
MANSYUR 510(k) STATEMENT
JAKARTA BARAT, INDONESIA 11210
DEVICE: TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PR
ARROW INTL., INC. 510(k) NO: K003006(TRADITIONAL)
ATTN: THOMAS D NICKEL PHONE NO : 610-478-3137
2400 BERNVILLE RD. SE DECISION MADE: 27-OCT-00
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATOM INFA WARMER V-505
ATOM MEDICAL CORPORATION 510(k) NO: K002355(ABBREVIATED)
ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 10-OCT-00
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
AUTOMATIC LIQUID PACKAGING, INC. 510(k) NO: K994321(TRADITIONAL)
ATTN: JOHN BRDA PHONE NO : 815-338-9500
2200 LAKE SHORE DR. SE DECISION MADE: 25-OCT-00
WOODSTOCK, IL 60098 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE
AVITRO LLC 510(k) NO: K000632(TRADITIONAL)
ATTN: JOHN BRDA PHONE NO : 815-338-9500
2200 LAKE SHORE DRIVE SE DECISION MADE: 19-OCT-00
WOODSTOCK, IL 60098 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD
AVITRO LLC 510(k) NO: K001795(TRADITIONAL)
ATTN: JOHN BRDA PHONE NO : 815-338-9500
2200 LAKE SHORE DRIVE SE DECISION MADE: 19-OCT-00
WOODSTOCK, IL 60098 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHOENIX DIGITAL EEG
AXON SYSTEMS, INC. 510(k) NO: K002316(TRADITIONAL)
ATTN: HOWARD BAILIN PHONE NO : 800-888-2966
400-2200 OSER AVE. SE DECISION MADE: 26-OCT-00
HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)
AXYA MEDICAL, INC. 510(k) NO: K002557(TRADITIONAL)
ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510
100 CUMMINGS CENTER SE DECISION MADE: 06-OCT-00
SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY, MA 01915
DEVICE: RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION
BAUSCH & LOMB, INC. 510(k) NO: K002823(TRADITIONAL)
ATTN: PAUL G STAPLETON PHONE NO : 716-338-8172
1400 NORTH GOODMAN ST. SE DECISION MADE: 17-OCT-00
ROCHESTER, NY 14603-0450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
BAXTER HEALTHCARE CORP. 510(k) NO: K003225(SPECIAL)
ATTN: MARY ELLEN SNYDER PHONE NO : 847-270-4644
RT. 120 AND WILSON ROAD SE DECISION MADE: 19-OCT-00
ROUND LAKE, IL 60073-0490 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY
BAYER CORP. 510(k) NO: K002376(TRADITIONAL)
ATTN: WILLIAM J PIGNATO PHONE NO : 508-359-3825
63 NORTH ST. SE DECISION MADE: 26-OCT-00
MEDFIELD, MA 02052-1688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEME
BAYLIS MEDICAL CO., INC. 510(k) NO: K002389(TRADITIONAL)
ATTN: KRIS SHAH PHONE NO : 905 602 4875
5160 EXPLORER DRIVE, UNIT 37 SE DECISION MADE: 23-OCT-00
MISSISSAUGA, CANADA L4W-4T7 510(k) STATEMENT
DEVICE: PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100
BECKMAN COULTER, INC. 510(k) NO: K002799(SPECIAL)
ATTN: ANNETTE HELLIE PHONE NO : 714-993-8767
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 05-OCT-00
BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
BECKMAN COULTER, INC. 510(k) NO: K002905(TRADITIONAL)
ATTN: MARA CALER PHONE NO : 858-621-4583
7330 CARROLL ROAD SE DECISION MADE: 19-OCT-00
SAD DIEGO, CA 92196-9006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BVI SLING
BIO-VASCULAR, INC. 510(k) NO: K002233(TRADITIONAL)
ATTN: DAISY P SIN PHONE NO : 651-603-5203
2575 UNIVERSITY AVE., STE.180 SE DECISION MADE: 13-OCT-00
ST. PAUL, MN 55114-1024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER
BIOCARE CORP. 510(k) NO: K002855(TRADITIONAL)
ATTN: PAUL W MCDONALD PHONE NO : 781-894-0800
200 PROSPECT STREET SE DECISION MADE: 12-OCT-00
WALTHAM, MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOCHECK TESTOSTERONE EIA, MODEL BC-1115
BIOCHECK, INC. 510(k) NO: K002294(TRADITIONAL)
ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646
9418 LASAINE AVE SE DECISION MADE: 02-OCT-00
NORTHRIDGE, CA 91325 510(k) STATEMENT
DEVICE: WUJIN #3 TIBIAL NAIL
BIOLOGICALLY ORIENTED PROSTHESES 510(k) NO: K002325(TRADITIONAL)
ATTN: ANGENA PAREKH PHONE NO : 810-982-7777
17 SEVENTEENTH ST. SE DECISION MADE: 30-OCT-00
PORT HURON, MI 48060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
BIOMERIEUX, INC. 510(k) NO: K001460(TRADITIONAL)
ATTN: JANET CONNOLLY PHONE NO : 781-871-4442
1022 HINGHAM STREET SE DECISION MADE: 04-OCT-00
ROCKLAND, MA 02370 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BROOKER TIBIA NAILS
BIOMET ORTHOPEDICS, INC. 510(k) NO: K002057(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 04-OCT-00
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BROOKER FEMORAL NAILS
BIOMET ORTHOPEDICS, INC. 510(k) NO: K002278(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-269-6639
P.O. BOX 587 SE DECISION MADE: 23-OCT-00
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LACTOSORB PUSH SCREW
BIOMET, INC. 510(k) NO: K002423(TRADITIONAL)
ATTN: TRACY BICKEL PHONE NO : 219-372-1761
56 EAST BELL DRIVE SE DECISION MADE: 20-OCT-00
WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENT XXL CLOSED BOX FEMORAL COMPONENT
BIOMET, INC. 510(k) NO: K002772(SPECIAL)
ATTN: MICHELLE L MCKINLEY PHONE NO : 219-372-1644
AIRPORT INDUSTRIAL PARK, SE DECISION MADE: 04-OCT-00
P.O.BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46580
DEVICE: BIOMET BI-POLAR SHOULDER SYSTEM
BIOMET, INC. 510(k) NO: K002998(SPECIAL)
ATTN: TRACY J BICKE; PHONE NO : 219-372-1761
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 06-OCT-00
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
BIOPLATE, INC. 510(k) NO: K002879(SPECIAL)
ATTN: ERIC V HOHENSTEIN PHONE NO : 323-549-9500
6911 MELROSE AVE. SE DECISION MADE: 05-OCT-00
LOS ANGELES, CA 90038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GL
BIOPRO (M) SDN BHD 510(k) NO: K994276(TRADITIONAL)
ATTN: JAMES H LALE PHONE NO : 603 376 1386
LOT14, PT.4204 LINGKARN SULTAN SE DECISION MADE: 20-OCT-00
HISHAMUDDIN, NORTH PORT INDU. 510(k) STATEMENT
PORT KLANG, MALAYSIA 42000
DEVICE: BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION G
BIOPRO (M) SDN BHD 510(k) NO: K994281(TRADITIONAL)
ATTN: JAMES H LALE PHONE NO : 603 376 1390
LOT14, PT.4204 LINGKARN SULTAN SE DECISION MADE: 20-OCT-00
HISHAMUDDIN, NORTH PORT INDU. 510(k) STATEMENT
PORT KLANG, MALAYSIA 42000
DEVICE: NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K002133(TRADITIONAL)
ATTN: JODI LYNN GREENNIZEN PHONE NO : 508-652-5008
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 12-OCT-00
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPID EXCHANGE TAPERTOME
BOSTON SCIENTIFIC CORP. 510(k) NO: K002802(SPECIAL)
ATTN: CAROL J HOLLOWAY PHONE NO : 508-650-8514
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 05-OCT-00
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCANPRO CREAM
BRENNEN MEDICAL, INC. 510(k) NO: K002077(TRADITIONAL)
ATTN: PHILLIP LAWIN PHONE NO : 651-429-7413
1290 HAMMOND RD. SE DECISION MADE: 02-OCT-00
ST. PAUL, MN 55110 510(k) STATEMENT
DEVICE: BETA GLUCAN GEL (MACROPRO GEL)
BRENNEN MEDICAL, INC. 510(k) NO: K002078(TRADITIONAL)
ATTN: PHILLIP LAWIN PHONE NO : 651-429-7413
1290 HAMMOND RD. SE DECISION MADE: 02-OCT-00
ST. PAUL, MN 55110 510(k) STATEMENT
DEVICE: BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE
C.R. BARD, INC. 510(k) NO: K002094(TRADITIONAL)
ATTN: MARION GORDON PHONE NO : 978-262-4867
129 CONCORD RD., BLDG. 3 SE DECISION MADE: 06-OCT-00
BILLERICA, MA 01821-7031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPOSIX E/X MESH
C.R. BARD, INC. 510(k) NO: K002684(TRADITIONAL)
ATTN: RUTH C FORSTADT PHONE NO : 401-463-7000
100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 11-OCT-00
CANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOF
CANTOR & SILVER LTD. 510(k) NO: K994320(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 20-OCT-00
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY
CEDARA SOFTWARE CORPORATION 510(k) NO: K002590(TRADITIONAL)
ATTN: CAROL NAKAGAWA PHONE NO : 905 672 2100
6509 AIRPORT RD. SE DECISION MADE: 31-OCT-00
MISSISSAUGA, ONTARIO, CANADA L4V 1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15
CERAMOPTEC, INC. 510(k) NO: K002296(TRADITIONAL)
ATTN: CAROL J MORELLO PHONE NO : 413-525-0600
515 SHAKER ROAD SE DECISION MADE: 02-OCT-00
EAST LONGMEADOW, MA 01028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE
CIVCO MEDICAL INSTRUMENTS CO., INC510(k) NO: K002546(TRADITIONAL)
ATTN: J. WILLIAM JONES PHONE NO : 319-656-4447
102 FIRST ST. SOUTH SE DECISION MADE: 31-OCT-00
KALONA, IA 52247 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOSTAT II ENA-6 PROFILE ELISA
COGENT DIAGNOTICS LTD. 510(k) NO: K003054(TRADITIONAL)
ATTN: DANIELLE KNIGHT PHONE NO : 714-933-3000
PENTLANDS SCIENCE PARK SE DECISION MADE: 13-OCT-00
BUSH LOAN, PENICUIK 510(k) STATEMENT
MIDLOTHIAN, SCOTLAND, UNITED KINGDOM EH26 OPL
DEVICE: AUTOSTAT II ENA-4 PROFILE ELISA
COGENT DIAGNOTICS LTD. 510(k) NO: K003057(TRADITIONAL)
ATTN: DANIELLE KNIGHT PHONE NO : 714-933-3000
PENTLANDS SCIENCE PARK SE DECISION MADE: 13-OCT-00
BUSH LOAN, PENICUIK 510(k) STATEMENT
MIDLOTHIAN, SCOTLAND, UNITED KINGDOM EH26 OPL
DEVICE: FOCUS
COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K002147(TRADITIONAL)
ATTN: MICHAEL A PARSONS PHONE NO : 314-993-0003
1145 CORPORATE LAKE DR. SE DECISION MADE: 13-OCT-00
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
ST. LOUIS, MO 63132-1716
DEVICE: GUNTHER TULIP VENA CAVA MREYE FILTER SET
COOK, INC. 510(k) NO: K000855(TRADITIONAL)
ATTN: MARY GOSSARD PHONE NO : 812-339-2235
925 SOUTH CURRY PIKE SE DECISION MADE: 18-OCT-00
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402
DEVICE: CORDIS SLALOM PTA BALLOON CATHETER
CORDIS CORP. 510(k) NO: K003159(SPECIAL)
ATTN: CHUCK RYAN PHONE NO : 908-412-7446
7 POWDERHORN DRIVE SE DECISION MADE: 30-OCT-00
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB
CORE-VENT CORP. 510(k) NO: K002188(TRADITIONAL)
ATTN: WILL FISHER PHONE NO : 702-253-1344
4630 SOUTH ARVILLE, SUITE D SE DECISION MADE: 30-OCT-00
LAS VEGAS, NV 89103 510(k) STATEMENT
DEVICE: BIOMESH P1 AND BIOMESH PLUG AND PATCH
COUSIN BIOTECH S.A.R.L 510(k) NO: K002479(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 19-OCT-00
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECAT PET SCANNER
CTI PET SYSTEMS, INC. 510(k) NO: K002715(TRADITIONAL)
ATTN: WILLIAM SKREMSKY PHONE NO : 865-218-2522
810 INNOVATION DR. SE DECISION MADE: 31-OCT-00
KNOXVILLE, TN 37932-2571 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES,
CURON MEDICAL, INC. 510(k) NO: K002898(SPECIAL)
ATTN: THOMAS C WEHMAN PHONE NO : 408-733-9910
735 PALOMAR AVENUE SE DECISION MADE: 17-OCT-00
SUNNYVALE, CA 94086 510(k) STATEMENT
DEVICE: GLOBAL SPINAL FIXATION SYSTEM
D.K.M. CO.,LTD. 510(k) NO: K001668(TRADITIONAL)
ATTN: ANDREW PAENG PHONE NO : 573-225-7700
P.O. BOX 3415 SE DECISION MADE: 19-OCT-00
ST. LOUIS, MO 63143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATO
DADE BEHRING, INC. 510(k) NO: K002551(TRADITIONAL)
ATTN: PAUL L ROGERS PHONE NO : 408-239-2309
3403 YERBA BUENA ROAD SE DECISION MADE: 11-OCT-00
P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95161-9013
DEVICE: N PROTEIN STANDARD SL
DADE BEHRING, INC. 510(k) NO: K002804(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
GLASGOW SITE SE DECISION MADE: 05-OCT-00
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOP
DADE BEHRING, INC. 510(k) NO: K002974(TRADITIONAL)
ATTN: PAUL L ROGERS PHONE NO : 408-239-2309
3403 YERBA BUENA ROAD SE DECISION MADE: 11-OCT-00
SAN JOSE, CA 95161-9013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION T
DATASCOPE CORP. 510(k) NO: K002949(SPECIAL)
ATTN: JOANNE WOLF PHONE NO : 973-244-6100
15 LAW DR. SE DECISION MADE: 20-OCT-00
FAIRFIELD, NJ 07004-0011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L
DATEX-OHMEDA, INC. 510(k) NO: K002478(TRADITIONAL)
ATTN: JOEL C KENT PHONE NO : 978-640-0460
3 HIGHWOOD DR. SE DECISION MADE: 05-OCT-00
TEWKSBURY, MA 01876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
DEPILASE GROUP LTD. 510(k) NO: K001990(TRADITIONAL)
ATTN: MARIO LUCA RUSSO PHONE NO : 440 207 8496120
12 ST. JAMES'S SQUARE SE DECISION MADE: 23-OCT-00
LONDON SW1 Y 4RB, UNITED KINGDOM S510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K002883(SPECIAL)
ATTN: CHERYL K HASTINGS PHONE NO : 219-371-4901
700 ORTHOPAEDIC DR. SE DECISION MADE: 13-OCT-00
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM
EBI, L.P. 510(k) NO: K002980(SPECIAL)
ATTN: PATRICIA FLOOD PHONE NO : 973-299-9022
100 INTERPACE PKWY. SE DECISION MADE: 23-OCT-00
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WACKERS-LIU CQ SOFTWARE
ECLIPSE SYSTEMS INC. 510(k) NO: K002229(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 20-OCT-00
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG
EEMAGINE MEDICAL IMAGING SOLUTIONS510(k) NO: K002631(TRADITIONAL)
ATTN: SCOTT PEASE PHONE NO : 262-363-5546
W306 D8345 CHESNUT DRIVE SE DECISION MADE: 23-OCT-00
MUKWONAGO, WI 53149 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL
ELECTRO MEDICAL SYSTEMS SA 510(k) NO: K002484(TRADITIONAL)
ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0460
49 PLAIN STREET SE DECISION MADE: 04-OCT-00
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ISOBAR SPINAL SYSTEM
ENCORE ORTHOPEDICS, INC. 510(k) NO: K002959(SPECIAL)
ATTN: JOANNA DROEGE PHONE NO : 512-834-6255
9800 METRIC BLVD. SE DECISION MADE: 16-OCT-00
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDIUS ENDOSCOPIC ACCESS SYSTEM
ENDIUS INC. 510(k) NO: K002437(TRADITIONAL)
ATTN: SUSAN FINNERAN PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 02-OCT-00
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOCARE PERCUTANEOUS ACCESS SET
ENDOCARE, INC. 510(k) NO: K002396(TRADITIONAL)
ATTN: VINCENT CUTARELLI PHONE NO : 949-595-5424
7 STUDEBAKER SE DECISION MADE: 13-OCT-00
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEADBAND FOR BAHA
ENTIFIC MEDICAL SYSTEMS INC. 510(k) NO: K002913(TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 612-571-1976
6470 RIVERVIEW TERRACE SE DECISION MADE: 17-OCT-00
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELRAN 01 SYSTEM
ENVISION ADVANCED MEDICAL SYSTEM L510(k) NO: K002431(ABBREVIATED)
ATTN: GERARD J PRUD'HOMME PHONE NO : 202-637-5735
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 24-OCT-00
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUPALAMUS DEFLECTABLE STYLET, MODEL 01545
EUPALAMUS, LLC 510(k) NO: K002534(TRADITIONAL)
ATTN: ANNE LAURITZEN PHONE NO : 310-471-6289
3411 MANDEVILLE CANYON ROAD SE DECISION MADE: 18-OCT-00
BRENTWOOD, CA 90049 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLASMAKINETIC GENERATOR
EVEREST MEDICAL CORP. 510(k) NO: K003060(SPECIAL)
ATTN: DAVID KAY PHONE NO : 44 029 20776300
FORTRAN ROAD, SE DECISION MADE: 31-OCT-00
ST. MELLONS, CARDIFF, UNITED KINGD510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EEG SPIKE AND EVENT DETECTOR MODULE
EXCEL TECH. LTD. 510(k) NO: K002332(TRADITIONAL)
ATTN: DEBBIE DAVY PHONE NO : 905 829 5300
2568 BRISTOL CIRCLE SE DECISION MADE: 06-OCT-00
OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIRECT CROWN
FLEXIBLE DIMENSIONS LLC 510(k) NO: K001884(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 25-OCT-00
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MOD
FLUORO SCAN IMAGING SYSTEMS, INC. 510(k) NO: K002198(TRADITIONAL)
ATTN: WILLIAM J ENGEL PHONE NO : 847-564-5400
650-B ANTHONY TRAIL SE DECISION MADE: 17-OCT-00
NORTHBROOK, IL 60062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER
FONAR CORP. 510(k) NO: K002490(TRADITIONAL)
ATTN: LUCIANO BONANNI PHONE NO : 631-694-2929
110 MARCUS DR SE DECISION MADE: 03-OCT-00
MELVILLE, NY 11747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEEDNET, MODEL EP6T5, EP5E5
GALIL MEDICAL LTD. 510(k) NO: K003065(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEEN ST. SE DECISION MADE: 31-OCT-00
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER
GAMBRO HEALTHCARE 510(k) NO: K994390(TRADITIONAL)
ATTN: JEFFREY R SHIDEMAN PHONE NO : 612-835-4018
1185 OAK ST. SE DECISION MADE: 26-OCT-00
LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLAR SPO2 MODULE WITH MASIMO SET
GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K002957(SPECIAL)
ATTN: DAVID WAHLIG PHONE NO : 414-362-2090
8200 WEST TOWER AVE. SE DECISION MADE: 18-OCT-00
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGTHSPEED 3.0 CT SCANNER SYSTEM
GE MEDICAL SYSTEM 510(k) NO: K002978(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
16800 RYERSON ROAD SE DECISION MADE: 10-OCT-00
NEW BERLIN, WI 53151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNA MFO/I MAGNETIC RESONANCE SYSTEM
GE MEDICAL SYSTEMS 510(k) NO: K002611(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. BOX 414, W-709 SE DECISION MADE: 31-OCT-00
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMAL CAUTERY UNIT, MODEL 150
GEIGER MEDICAL TECHNOLOGIES, INC. 510(k) NO: K002341(TRADITIONAL)
ATTN: JOHN BOTTJER PHONE NO : 949-240-7584
24040 CAMINO DEL AVION, A-195 SE DECISION MADE: 23-OCT-00
MONARCH BEACH, CA 92629 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REUSABLE CANNULA
GENICON, LC 510(k) NO: K002542(TRADITIONAL)
ATTN: GARY HABERLAND PHONE NO : 407-273-7619
573 WATERSCAPE WAY SE DECISION MADE: 23-OCT-00
ORLANDO, FL 32828 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING
GEUDER GMBH 510(k) NO: K001125(TRADITIONAL)
ATTN: HILLARD W WELCH PHONE NO : 508-771-6777
344 ANNABELLE POINT ROAD SE DECISION MADE: 04-OCT-00
CENTERVILLE, MA 02632-2402 510(k) STATEMENT
DEVICE: CRANIOCAP
GILLETTE CHILDREN'S SPECIALTY HEAL510(k) NO: K000861(TRADITIONAL)
ATTN: LINDA VALERI PHONE NO : 651-229-3808
1785 GOLD COURT SE DECISION MADE: 30-OCT-00
EAGAN, MN 55122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACUETTE WITH PPACK
GREINER VACUETTE NORTH AMERICA, IN510(k) NO: K002777(TRADITIONAL)
ATTN: JUDI SMITH PHONE NO : 410-313-8003
P.O. BOX 6581 SE DECISION MADE: 05-OCT-00
ELLICOTT CITY, MD 21042-0581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER
GUIDANT CARDIAC AND VASCULAR SURGE510(k) NO: K002676(TRADITIONAL)
ATTN: KRISTEN HONL PHONE NO : 650-470-6200
1525 O'BRIEN DR. SE DECISION MADE: 30-OCT-00
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
GUIDANT CORP. 510(k) NO: K002143(TRADITIONAL)
ATTN: SUSAN SILAVIN, PH.D. PHONE NO : 408-845-3127
3200 LAKESIDE DR. SE DECISION MADE: 12-OCT-00
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW
H&C MEDICAL DEVICES SPA 510(k) NO: K002074(TRADITIONAL)
ATTN: ATTILIO CASTELLI PHONE NO : 046-385-0125
VIA PISA 250 SE DECISION MADE: 04-OCT-00
20099 SESTO SAN GIOVANNI 510(k) SUMMARY AVAILABLE FROM FDA
MILAN, ITALY
DEVICE: HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST
HARALD NORDIN S.A 510(k) NO: K003219(SPECIAL)
ATTN: JAMES DELANEY PHONE NO : 978-371-0066
100 MAIN STREET; SUITE 120 SE DECISION MADE: 25-OCT-00
CONCORD, MA 01742 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST
HARALD NORDIN S.A 510(k) NO: K003221(SPECIAL)
ATTN: JAMES DELANEY PHONE NO : 978-371-0066
100 MAIN STREET; SUITE 120 SE DECISION MADE: 25-OCT-00
CONCORD, MA 01742 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARDY DISK CEFTIZOXIME, 30MCG
HARDY DIAGNOSTICS 510(k) NO: K002367(TRADITIONAL)
ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 26-OCT-00
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: HARDYDISK STREPTOMYCIN, 300MCG
HARDY DIAGNOSTICS 510(k) NO: K002368(TRADITIONAL)
ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 25-OCT-00
SANTA MARIA, CA 93455 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARDYDISK GENTAMICIN, 120MCG
HARDY DIAGNOSTICS 510(k) NO: K002369(TRADITIONAL)
ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 26-OCT-00
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: HARDYDISK CEFUROXIME, 30MCG
HARDY DIAGNOSTICS 510(k) NO: K002656(TRADITIONAL)
ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 25-OCT-00
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: HARDYDISK LOMEFLOXACIN, 10MCG
HARDY DIAGNOSTICS 510(k) NO: K002660(TRADITIONAL)
ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 26-OCT-00
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: HARDYDISK CEFOTETAN, 30MCG
HARDY DIAGNOSTICS 510(k) NO: K002661(TRADITIONAL)
ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 26-OCT-00
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: HARDYDISK NETILMICIN, 30MCG
HARDY DIAGNOSTICS 510(k) NO: K002663(TRADITIONAL)
ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 19-OCT-00
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: HARDYDISK LEVOFLOXACIN, 5MCG
HARDY DIAGNOSTICS 510(k) NO: K002664(TRADITIONAL)
ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 26-OCT-00
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551
HDC CORP. 510(k) NO: K994059(TRADITIONAL)
ATTN: JAMES ABILLA PHONE NO : 408-954-1909
2109 O'TOOLE AVE. SE DECISION MADE: 13-OCT-00
SAN JOSE, CA 95131 510(k) STATEMENT
DEVICE: HL168B
HEALTH & LIFE CO., LTD. 510(k) NO: K002882(SPECIAL)
ATTN: PAUL YANG PHONE NO : 886 2 32349600
6F,NO. 407, CHUNG SHAN RD. SE DECISION MADE: 13-OCT-00
SEC.02, CHUNG HO CITY 510(k) STATEMENT
TAIPEI HSIEN, CHINA (TAIWAN)
DEVICE: RAICHEM PHOSPORUS REAGENT
HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K003012(SPECIAL)
ATTN: JOSE A MONTANEZ PHONE NO : 443-367-5518
9033 RED BRANCH ROAD SE DECISION MADE: 25-OCT-00
COLUMBIA, MD 21045-2105 510(k) STATEMENT
DEVICE: NARKOMAT, MODEL 2000
HEYER AMERICA, INC. 510(k) NO: K000995(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
3234 ELLA LANE SE DECISION MADE: 11-OCT-00
NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HITACHI ALTAIRE
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K002420(ABBREVIATED)
ATTN: DOUGLAS THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 17-OCT-00
TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUREONE INSULIN SYRINGE
HOSUK CO., LTD. 510(k) NO: K002921(TRADITIONAL)
ATTN: Y. H KIM PHONE NO : 011 82 438830411
52-6 DUKJEONG-RI, SAMSUNG-MYUN SE DECISION MADE: 18-OCT-00
UMSUNG-GUN, CHUNGCHEONG, REPUBLIC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIA SPINE SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K002505(SPECIAL)
ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117
59 ROUTE 17 SE DECISION MADE: 05-OCT-00
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIA SPINE SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K002858(SPECIAL)
ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117
59 ROUTE 17 SE DECISION MADE: 13-OCT-00
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID
HUNTER RESEARCH LABORATORIES, INC.510(k) NO: K002213(TRADITIONAL)
ATTN: BARBARA PEDIGO PHONE NO : 303-744-1989
1541 SOUTH VINE ST. SE DECISION MADE: 03-OCT-00
DENVER, CO 80210 510(k) STATEMENT
DEVICE: I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300
I-STAT CORP. 510(k) NO: K001387(TRADITIONAL)
ATTN: PAUL VANDERWERF PHONE NO : 609-469-0242
104 WINDSOR CENTER DR. SE DECISION MADE: 05-OCT-00
EAST WINDSOR, NJ 08520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK
IC-USA, INC. 510(k) NO: K001972(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 27-OCT-00
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BURR HOLE COVER, MODEL XX
IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K001096(TRADITIONAL)
ATTN: DAVID M LEE PHONE NO : 321-757-8990
2290 EAU GALLIE BLVD. SE DECISION MADE: 25-OCT-00
MELBOURNE, FL 32935 510(k) STATEMENT
DEVICE: NAVIGUS PEEL AWAY INTRODUCER
IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K002330(TRADITIONAL)
ATTN: DAVID M LEE PHONE NO : 321-757-8990
2290 EAU GALLIE BLVD. SE DECISION MADE: 18-OCT-00
MELBOURNE, FL 32935 510(k) STATEMENT
DEVICE: PINS AND WIRES
IMPLANT RESOURCE, INC. 510(k) NO: K002125(TRADITIONAL)
ATTN: AL LIPPINCOTT PHONE NO : 952-492-5858
3150 E. 200TH STREET SE DECISION MADE: 11-OCT-00
PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPOAID
IMPOAID, INC. 510(k) NO: K000730(TRADITIONAL)
ATTN: ELAIN DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 19-OCT-00
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSIGHT 4000 ENDOSCOPE
INSIGHT INSTRUMENTS MFG., INC. 510(k) NO: K000252(TRADITIONAL)
ATTN: K. PETER LULOH PHONE NO : 407-324-2727
5400 SOUTH BRYANT AVE. SE DECISION MADE: 17-OCT-00
SANFORD, FL 32773 510(k) STATEMENT
DEVICE: COALIZA PROTEIN S-FREE
INSTRUMENTATION LABORATORY CO. 510(k) NO: K002467(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 13-OCT-00
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM
INTERPORE CROSS INTL. 510(k) NO: K002592(TRADITIONAL)
ATTN: PROSIE REY-FESSLER PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 06-OCT-00
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
INVACARE CORP. 510(k) NO: K002284(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-329-6595
ONE INVACARE WAY SE DECISION MADE: 24-OCT-00
ELYRIA, OH 44036-2125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSQ3
IOMED, INC. 510(k) NO: K001522(TRADITIONAL)
ATTN: W. TIM MILLER PHONE NO : 801-975-1191
3385 WEST 1820 SOUTH SE DECISION MADE: 18-OCT-00
SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JEL BIOS PURE
J.F. JELENKO & CO., INC. 510(k) NO: K002645(TRADITIONAL)
ATTN: RAPHAEL JUDKINS PHONE NO : 914-273-8600
99 BUSINESS PARK DR. SE DECISION MADE: 19-OCT-00
ARMONK, NY 10504 510(k) STATEMENT
DEVICE: EQUITY
JENSEN INDUSTRIES, INC. 510(k) NO: K002826(ABBREVIATED)
ATTN: JOHN SLANSKI PHONE NO : 203-239-2090
50 STILLMAN RD. SE DECISION MADE: 24-OCT-00
NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-LIGHT 4000 SERIES MANUAL WHEELCHAIR
JIANGSU INTCO MEDICAL EQUIPMENT & 510(k) NO: K002669(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 909-548-4828
12390 EAST END AVENUE SE DECISION MADE: 11-OCT-00
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR
JIANGSU INTCO MEDICAL EQUIPMENT & 510(k) NO: K002670(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 909-548-4828
12390 EAST END AVENUE SE DECISION MADE: 11-OCT-00
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-TRAVELER 2500 SERIES MANUAL WHEELCHAIR
JIANGSU INTCO MEDICAL EQUIPMENT & 510(k) NO: K002671(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 909-548-4828
12390 EAST END AVENUE SE DECISION MADE: 11-OCT-00
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-COMFORT TRANSPORTER 2000 SERIES
JIANGSU INTCO MEDICAL EQUIPMENT & 510(k) NO: K002673(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 909-548-4828
12390 EAST END AVENUE SE DECISION MADE: 11-OCT-00
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELS CANNULA (KIT), MODEL M1210-88,M1510-88
JOSTRA AG 510(k) NO: K002857(TRADITIONAL)
ATTN: KATHLEEN JOHNSON PHONE NO : 302-454-9959
2035 SUNSET LAKE ROAD SE DECISION MADE: 05-OCT-00
NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE
KAMIYA BIOMEDICAL CO. 510(k) NO: K002558(SPECIAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 25-OCT-00
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: KSEA VASCULAR FIBERSCOPES
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K001408(TRADITIONAL)
ATTN: KEVIN KENNAN PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 30-OCT-00
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA UNIMAT 12
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K002700(TRADITIONAL)
ATTN: KEVIN KENNAN PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 18-OCT-00
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA NEURO-FIBERSCOPE
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K002788(TRADITIONAL)
ATTN: KEVIN KENNAN PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 23-OCT-00
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLU
KLS-MARTIN L.P. 510(k) NO: K002152(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
3234 ELLA LANE SE DECISION MADE: 10-OCT-00
NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESUSCI INFLATE-A-SHIELD CPR BARRIER
LAERDAL MEDICAL CORP. 510(k) NO: K001742(TRADITIONAL)
ATTN: CYNTHIA J NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 06-OCT-00
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPER NOVA, ACUBEAM
LIGHT FORCE THERAPY, INC. 510(k) NO: K001179(TRADITIONAL)
ATTN: KIM PETERSON PHONE NO : 719-749-2974
17725 CLEESE CT. SE DECISION MADE: 27-OCT-00
PAYTON, CO 80831 510(k) STATEMENT
DEVICE: ADVANTAGE DRIVE SYSTEM
LINVATEC CORP. 510(k) NO: K002523(TRADITIONAL)
ATTN: LAURA D SENEFF PHONE NO : 727-399-5234
11311 CONCEPT BOULEVARD SE DECISION MADE: 06-OCT-00
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMALITE CURE LIGHT, MODEL 2100
LUMALITE, INC. 510(k) NO: K002566(TRADITIONAL)
ATTN: JOSEPH M FOREHAND PHONE NO : 619-660-5410
2810 VIA ORANGE WAY, STE. B SE DECISION MADE: 19-OCT-00
SPRING VALLEY, CA 91978 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACROPOREMX MANDIBULAR FIXATION SYSTEM
MACROPORE, INC. 510(k) NO: K000696(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900
6740 TOP GUN ST. SE DECISION MADE: 19-OCT-00
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WHEELCHAIR, MECHANICAL SERIES MODEL 3100
MADA MEDICAL PRODUCTS, INC. 510(k) NO: K002943(TRADITIONAL)
ATTN: JEFFERY W ADAM PHONE NO : 201-460-0454
625 WASHINGTON AVE SE DECISION MADE: 23-OCT-00
CARLSTADT, NJ 07072 510(k) STATEMENT
DEVICE: AERO-CLICK
MAP MEDIZINTECHNIK FUR ARZT UND PA510(k) NO: K993094(TRADITIONAL)
ATTN: TORSTEN SCHLICHTHOLZ PHONE NO : 498 989 518723
FRAUNHOFERSTRASSE 16 SE DECISION MADE: 23-OCT-00
MUNCHEN, GERMANY D-82152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPONDER 3000
MARQUETTE HELLIGE GMBH 510(k) NO: K000638(TRADITIONAL)
ATTN: KLAUS RUDOLF PHONE NO : 761-454-3379
MUNZINGER STR. 3 SE DECISION MADE: 30-OCT-00
D-79111 FREIBURG, GERMANY 79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMBINED PHYSIOLOGICAL MONITORING SYSTEM
MARYROSE CUSIMANO, PH.D. & SCOTT Z510(k) NO: K002104(TRADITIONAL)
ATTN: MARYROSE CUSIMANO PHONE NO : 954-578-6884
7481 W. OAKLAND PARK BLVD. SE DECISION MADE: 10-OCT-00
# 305 510(k) SUMMARY AVAILABLE FROM FDA
FT. LAUDERDALE, FL 33319
DEVICE: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES
MASIMO CORP. 510(k) NO: K002751(SPECIAL)
ATTN: JAMES J CRONIN PHONE NO : 949-250-9688
2852 KELVIN AVE. SE DECISION MADE: 05-OCT-00
IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE
MASIMO CORP. 510(k) NO: K002939(SPECIAL)
ATTN: JAMES J CRONIN PHONE NO : 949-250-9688
2852 KELVIN AVE. SE DECISION MADE: 06-OCT-00
IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GL
MAXXIM MEDICAL 510(k) NO: K002933(ABBREVIATED)
ATTN: PALLIE STODDARD PHONE NO : 864-369-7391
308 CHURCH STREET SE DECISION MADE: 19-OCT-00
HONE PATH, SC 29654 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROLITE PULSED LIGHT SYSTEM
MEDICAL BIO CARE SWEDEN AB 510(k) NO: K000929(TRADITIONAL)
ATTN: CONNIE WHITE HOY PHONE NO : 505-323-2403
9630 TOWNER NE SE DECISION MADE: 17-OCT-00
ALBUQUERQUE, NM 87112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PBN FALLOPIAN TUBE CATHETER SYSTEM
MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K000620(TRADITIONAL)
ATTN: KARL SWARTZ PHONE NO : 352-338-0440
3600 S.W. 47TH AVE. SE DECISION MADE: 30-OCT-00
GAINESVILLE, FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIR BILIARY STENT
MEDINOL LTD. 510(k) NO: K002130(SPECIAL)
ATTN: NASR SALMAN PHONE NO : 972 648 1448
KIRYAT ATIDIM, P.O.B. 58165 SE DECISION MADE: 30-OCT-00
TEL-AVIV, ISRAEL 61581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS
MEDISON AMERICA, INC. 510(k) NO: K003121(TRADITIONAL)
ATTN: GARY J ALLSEBROK PHONE NO : 510-276-3559
16303 PANORAMIC WAY SE DECISION MADE: 20-OCT-00
SAN LEANDRO, CA 94578-1116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS ALERT GAUGE
MEDISYSTEMS CORP. 510(k) NO: K002372(TRADITIONAL)
ATTN: FREDRIC SWINDLER PHONE NO : 206-621-6500
1201 3RD AVE. SE DECISION MADE: 25-OCT-00
SEATTLE, WA 98101-3016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT
MEDIVANCE, INC. 510(k) NO: K002577(TRADITIONAL)
ATTN: ROBERT A KLINE PHONE NO : 303-926-1917
500 S. ARTHUR AVENUE, STE 100 SE DECISION MADE: 26-OCT-00
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW
MEDLINE INDUSTRIES, INC. 510(k) NO: K003091(TRADITIONAL)
ATTN: LARA N SIMMONS PHONE NO : 847-949-2639
ONE MEDLINE PL. SE DECISION MADE: 24-OCT-00
MUNDELEIN, IL 60060-4486 510(k) STATEMENT
DEVICE: MENICON PROGENT REMOVER
MENICON CO. LTD. 510(k) NO: K002140(TRADITIONAL)
ATTN: BEVERLEY D VENUTI PHONE NO : 978-658-6888
269A BALLARDVALE STREET SE DECISION MADE: 10-OCT-00
WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOBEEPER CB12/12, MODEL CB12/12
MERIDIAN MEDICAL TECHNOLOGIES LTD.510(k) NO: K002310(TRADITIONAL)
ATTN: GERARD LYNN PHONE NO : 442 890 222333
207 AIRPORT RD., WEST SE DECISION MADE: 25-OCT-00
BELFAST, IRELAND BT3 9ED 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INQWIRE DIAGNOSTIC GUIDE WIRE
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K002289(SPECIAL)
ATTN: CHESTER MCCOY PHONE NO : 801-208-4404
1600 WEST MERIT PKWY. SE DECISION MADE: 04-OCT-00
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDI GLIADIN A TEST
MICRO DETECT, INC. 510(k) NO: K002358(TRADITIONAL)
ATTN: MEHDI ALEM PHONE NO : 714-832-8234
2852 WALNUT AVE., SUITE H-1 SE DECISION MADE: 19-OCT-00
TUSTIN, CA 92780-7033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDI GLIADIN G TEST
MICRO DETECT, INC. 510(k) NO: K002359(TRADITIONAL)
ATTN: MEHDI ALEM PHONE NO : 714-832-8234
2852 WALNUT AVE., SUITE H-1 SE DECISION MADE: 19-OCT-00
TUSTIN, CA 92780-7033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM
MIDMARK CORP. 510(k) NO: K003090(ABBREVIATED)
ATTN: MIKE SNYDER PHONE NO : 937-526-8390
OUTE 47 WEST, VISTA DRIVE SE DECISION MADE: 18-OCT-00
VERSAILLES, OH 45380 510(k) STATEMENT
DEVICE: ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4
MISONIX, INC. 510(k) NO: K000927(TRADITIONAL)
ATTN: ALBERT F CLANCY JR. PHONE NO : 516-694-9555
1938 NEW HIGHWAY SE DECISION MADE: 10-OCT-00
FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MITEK CUFFTACK
MITEK PRODUCTS 510(k) NO: K003076(SPECIAL)
ATTN: CHRISTINE KUNTZ-NASSIF PHONE NO : 781-251-2794
249 VANDERBILT AVE. SE DECISION MADE: 27-OCT-00
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARRIAZO BARRAQUER II MICROKERATOME
MORIA S.A. 510(k) NO: K002191(TRADITIONAL)
ATTN: DAVID CONRAD PHONE NO : 331 467 44674
15 RUE GEORGES BESSE SE DECISION MADE: 12-OCT-00
ANTONY, FRANCE 92160 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR
NARISHIGE CO., LTD. 510(k) NO: K002850(TRADITIONAL)
ATTN: MITSUKO YONEYAMA PHONE NO : 813 330 88383
27-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 05-OCT-00
SETAGAY-KU, TOKYO 157-0062, JAPAN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACH
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K002686(SPECIAL)
ATTN: CHERYL NORTON PHONE NO : 763-694-3500
2800 NORTHWEST BLVD. SE DECISION MADE: 18-OCT-00
MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM
NEU-ION, INC. 510(k) NO: K001811(TRADITIONAL)
ATTN: LEE A HEIKKINEN PHONE NO : 410-944-5200
7200 RUTHERFORD RD. SE DECISION MADE: 25-OCT-00
SUITE 100 510(k) STATEMENT
BALTIMORE, MD 21244-2704
DEVICE: NICHOLS ADVANTAGE THYROGLOB
NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K002888(TRADITIONAL)
ATTN: JIMMY WONG PHONE NO : 949-240-5260
33047 CALLE AVIADOR SE DECISION MADE: 20-OCT-00
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFE SCOPE P, MODEL BSM-4100 SERIES
NIHON KOHDEN AMERICA, INC. 510(k) NO: K001693(TRADITIONAL)
ATTN: BONNIE BISHOP PHONE NO : 949-250-3210
2601 CAMPUS DR. SE DECISION MADE: 24-OCT-00
IRVINE, CA 92612-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500
NONIN MEDICAL, INC. 510(k) NO: K002690(SPECIAL)
ATTN: RICHARD P BENNETT PHONE NO : 612-553-9968
2605 FERNBROOK LANE, NORTH SE DECISION MADE: 11-OCT-00
MINNEAPOLIS, MN 55447-4755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY
NORDISKA DENTAL AB 510(k) NO: K002808(TRADITIONAL)
ATTN: RICHARD KIRSCHNER PHONE NO : 425-745-2584
P.O. BOX 435 SE DECISION MADE: 31-OCT-00
LYNWOOD, WA 98046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY
NORDISKA DENTAL AB 510(k) NO: K002810(TRADITIONAL)
ATTN: RICHARD KIRSCHNER PHONE NO : 425-745-2584
P.O. BOX 435 SE DECISION MADE: 31-OCT-00
LYNWOOD, WA 98046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY
NORDISKA DENTAL AB 510(k) NO: K002811(TRADITIONAL)
ATTN: RICHARD KIRSCHNER PHONE NO : 425-745-2584
P.O. BOX 435 SE DECISION MADE: 31-OCT-00
LYNWOOD, WA 98046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
NOVA BIOMEDICAL CORP. 510(k) NO: K002613(TRADITIONAL)
ATTN: PAUL W MACDONALD PHONE NO : 781-894-0800
200 PROSPECT ST. SE DECISION MADE: 19-OCT-00
WALTHAM, MA 02254-9141 510(k) STATEMENT
DEVICE: DISPOSABLE H-PE MICROKERATOME BLADES
OASIS 510(k) NO: K001464(TRADITIONAL)
ATTN: YVONNE FERNANDEZ PHONE NO : 626-914-2891
514 SOUTH VERMONT AVENUE SE DECISION MADE: 02-OCT-00
GLENDORA, CA 91741 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLAGEN WOUND DRESSING
OASIS RESEARCH, LLC 510(k) NO: K002443(TRADITIONAL)
ATTN: JAMES CHRISTENSEN PHONE NO : 909-305-9857
514 S. VERMONT AVENUE SE DECISION MADE: 18-OCT-00
GLENDORA, CA 91741 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTLENS
ODC OPHTHALMIC DEVELOPMENT CO. AG 510(k) NO: K002510(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
777 S. WADSWORTH BLVD. SE DECISION MADE: 18-OCT-00
BLDG. 2, SUITE 102 510(k) SUMMARY AVAILABLE FROM FDA
LAKEWOOD, CO 80226
DEVICE: OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
OLYMPUS AMERICA, INC. 510(k) NO: K002918(SPECIAL)
ATTN: MICHAEL CAMPBELL PHONE NO : 972-556-9697
3131 WEST ROYAL LANE SE DECISION MADE: 25-OCT-00
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
OLYMPUS AMERICA, INC. 510(k) NO: K002982(SPECIAL)
ATTN: MICHAEL CAMPBELL PHONE NO : 972-556-9697
3131 WEST ROYAL LANE SE DECISION MADE: 25-OCT-00
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM
OMNIGRACE (THAILAND) LTD. 510(k) NO: K002922(TRADITIONAL)
ATTN: WILLIAM E PATTON PHONE NO : 330-966-8878
7815 VANDERBILT DRIVE NW SE DECISION MADE: 16-OCT-00
NORTH CANTON, OH 44720 510(k) STATEMENT
DEVICE: TDK HANDPIECES
ORASYSTEMS, LLC 510(k) NO: K000848(TRADITIONAL)
ATTN: BERNARD SESSMAN PHONE NO : 973-227-5505
555 PASSAIC AVENUE SE DECISION MADE: 05-OCT-00
WEST CALDWELL, NJ 07006 510(k) STATEMENT
DEVICE: BACT/ALERT CSR
ORGANON TEKNIKA CORP. 510(k) NO: K003104(TRADITIONAL)
ATTN: REBECCA A RIVAS PHONE NO : 919-620-2288
100 AKZO AVE. SE DECISION MADE: 20-OCT-00
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR
OTTO BOCK ORTHOPEDIC INDUSTRY, INC510(k) NO: K000739(TRADITIONAL)
ATTN: WILLIAM JACKSON PHONE NO : 615-773-0002
3000 XENIUM LANE, SUITE N SE DECISION MADE: 24-OCT-00
PLYMOUTH, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSLEEP
OXFORD BIOSIGNALS LIMITED 510(k) NO: K002622(TRADITIONAL)
ATTN: PAULINE A HOBDAY PHONE NO : 440 186 5784840
OXFORD SCIENCE PARK SE DECISION MADE: 23-OCT-00
OXFORD, OX4 4 GA, UNITED KINGDOM O510(k) STATEMENT
DEVICE: DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CON
P.T. HEALTHCARE GLOVINDO 510(k) NO: K000838(TRADITIONAL)
ATTN: ELLEN HUTAPEA PHONE NO : 62 61 650015
JL. KOL. YOS SUDARSO K.M. 10 SE DECISION MADE: 23-OCT-00
KAWASAN INDUSRI MEDAN 510(k) STATEMENT
MEDAN, INDONESIA 10340
DEVICE: PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A,
PACE MEDICAL 510(k) NO: K002204(TRADITIONAL)
ATTN: ROBERT C MACE PHONE NO : 781-890-5656
391 TOTTEN POND RD. SE DECISION MADE: 18-OCT-00
WALTHAM, MA 02451 510(k) STATEMENT
DEVICE: MODEL 4815 ADAPTER
PACE MEDICAL 510(k) NO: K002496(TRADITIONAL)
ATTN: ROBERT C MACE PHONE NO : 781-890-5656
391 TOTTEN POND RD. SE DECISION MADE: 10-OCT-00
WALTHAM, MA 02451 510(k) STATEMENT
DEVICE: MODEL 4810 ANALYZER OUTPUT ADAPTER
PACE MEDICAL 510(k) NO: K002497(TRADITIONAL)
ATTN: ROBERT C MACE PHONE NO : 781-890-5656
391 TOTTEN POND RD. SE DECISION MADE: 10-OCT-00
WALTHAM, MA 02451 510(k) STATEMENT
DEVICE: PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-"X" & Z-13175-
PARADIGM MEDICAL INDUSTRIES, INC. 510(k) NO: K002228(TRADITIONAL)
ATTN: TRACY S BEST PHONE NO : 801-977-8970
2355 SOUTH 1070 WEST SE DECISION MADE: 06-OCT-00
SALT LAKE CITY, UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEATED HUMIDIFIER
PEGASUS RESEARCH CORP. 510(k) NO: K983783(TRADITIONAL)
ATTN: E J SMITH PHONE NO : 410-451-0639
1714 SOUTH LYON ST. SE DECISION MADE: 24-OCT-00
SANTA ANA, CA 92705 510(k) STATEMENT
DEVICE: PERCLOSE VASCULAR SUTURE DELIVERY DEVICE
PERCLOSE, INC. 510(k) NO: K001703(TRADITIONAL)
ATTN: DENISE C SUNGLETON PHONE NO : 650-474-3193
400 SAGINAW DRIVE SE DECISION MADE: 03-OCT-00
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETCAN HUBER NEEEDLE SET
PFM PRODUKTE FUR DIE MEDIZIN AG 510(k) NO: K002471(TRADITIONAL)
ATTN: SALVADORE F PALOMARES PHONE NO : 949-463-6146
15 CHEROKEE STREET SE DECISION MADE: 19-OCT-00
TRABUCO CANYON, CA 92679 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
PHARMACIA & UPJOHN CO. 510(k) NO: K002556(TRADITIONAL)
ATTN: TONI D ELLIOTT PHONE NO : 614-834-8629
592 CERESIA COURT SE DECISION MADE: 31-OCT-00
PICKERINGTON,, OH 43147 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TREPCHEK TREPONEMAL ANTIBODY EIA
PHOENIX BIOTECH CORP. 510(k) NO: K001552(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 908-362-9288
53 CEDAR LAKE ROAD SE DECISION MADE: 19-OCT-00
BLAIRSTOWN, NJ 07825 510(k) STATEMENT
DEVICE: 300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC
PIE MEDICAL 510(k) NO: K002880(TRADITIONAL)
ATTN: COLLEEN J HITTLE PHONE NO : 317-849-1916
SE DECISION MADE: 26-OCT-00
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPL CRIMP SYSTEM
PIONEER LABORATORIES, INC. 510(k) NO: K002110(TRADITIONAL)
ATTN: AMY H MOMMAERTS PHONE NO : 906-226-9909
375 RIVER PARK CIRCLE SE DECISION MADE: 06-OCT-00
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TC-PLUS SOLUTION KNEE
PLUS ORTHOPEDICS 510(k) NO: K000666(TRADITIONAL)
ATTN: HARTMUT LOCH PHONE NO : 858-455-2400
3550 GENERAL ATOMICS CT. SE DECISION MADE: 13-OCT-00
BLDG. 15-100 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121-1122
DEVICE: C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
POINTE SCIENTIFIC, INC. 510(k) NO: K002651(TRADITIONAL)
ATTN: RON JAMISON PHONE NO : 313-383-7220
1025 JOHN A. PAPALAS DR. SE DECISION MADE: 13-OCT-00
LINCOLN PARK, MI 48146 510(k) STATEMENT
DEVICE: RIGID GAS PERMEABLE CONTACT LENS
POLYMER TECHNOLOGY 510(k) NO: K002025(TRADITIONAL)
ATTN: DEBRA L.B. KETCHUM PHONE NO : 716-338-8638
1400 N GOODMAN STREET SE DECISION MADE: 31-OCT-00
P.O. BOX 30450 510(k) SUMMARY AVAILABLE FROM FDA
ROCHESTER, NY 14603-0450
DEVICE: SAFE MINI
POLYSTAN A/S 510(k) NO: K980974(TRADITIONAL)
ATTN: THOMAS ANDERSEN PHONE NO : 454-465-1566
WALGERHOLM 8 SE DECISION MADE: 13-OCT-00
VAERLOSE, DENMARK DK-3500 510(k) STATEMENT
DEVICE: MILLENNIUM EDITION 2000 ACCELERATED ELECTROFORMING SYSTEM
PRODUCT DEVELOPMENT INDUSTRIES, IN510(k) NO: K002675(TRADITIONAL)
ATTN: RODOLFO A CARBALLO PHONE NO : 520-881-2556
4500 EAST SPEEDWAY BLVD., #50 SE DECISION MADE: 25-OCT-00
TUCSON, AZ 85712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-POSURE SYSTEM VERSION 2 RAD
PRONOSCO A/S 510(k) NO: K002500(TRADITIONAL)
ATTN: JONATHAN KAHAN PHONE NO : 202-637-5794
555 13TH STREET SE DECISION MADE: 23-OCT-00
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000
PULMONETIC SYSTEMS, INC. 510(k) NO: K002881(SPECIAL)
ATTN: ROBERT HANKINS PHONE NO : 909-783-2280
930 SOUTH MT. VERNON AVE., SE DECISION MADE: 11-OCT-00
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
COLTON, CA 92324-3928
DEVICE: PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
PURITAN BENNETT CORP. 510(k) NO: K001646(TRADITIONAL)
ATTN: MARY E FUNK PHONE NO : 760-603-5957
2200 FARADAY AVE. SE DECISION MADE: 20-OCT-00
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER
QUALIGEN, INC. 510(k) NO: K003094(SPECIAL)
ATTN: DOROTHY DEINZER PHONE NO : 760-918-9165
2042 CORTE DEL NOGAL SE DECISION MADE: 25-OCT-00
CARLSBAD, CA 92009-1410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C.T.M. POWER CHAIR, MODEL HS-5600
R.S. MCQUATE AND ASSOCIATES, INC. 510(k) NO: K002983(TRADITIONAL)
ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651
3636 E. COLUMBINE DR. SE DECISION MADE: 11-OCT-00
PHOENIX, AZ 85032-7372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESSURE WIRE SENSOR, MODEL 12003/12303
RADI MEDICAL SYSTEMS AB 510(k) NO: K002962(SPECIAL)
ATTN: MATS GRANLUND PHONE NO : 461 816 1000
PALMBLADSGATAN 10 SE DECISION MADE: 04-OCT-00
UPPSALA, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIOMED SOURCE
RADIOMED CORPORATION 510(k) NO: K001070(TRADITIONAL)
ATTN: JOHN SCHWAMB PHONE NO : 978-663-7400
9 LINNELL CIRCLE SE DECISION MADE: 24-OCT-00
BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIONICS RF DISC CATHETER ELECTRODE SYSTEM
RADIONICS, INC. 510(k) NO: K001741(TRADITIONAL)
ATTN: KRISTINE CANAVAN PHONE NO : 781-272-1233
22 TERRY AVE. SE DECISION MADE: 23-OCT-00
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROMAP WITH NEURO 100
RADIONICS, INC. 510(k) NO: K002773(TRADITIONAL)
ATTN: NANCY C MACDONALD PHONE NO : 781-272-1233
22 TERRY AVE. SE DECISION MADE: 23-OCT-00
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX MICROALBUMIN
RANDOX LABORATORIES LTD. 510(k) NO: K002674(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 441 849 422413
55 DIAMOND RD. SE DECISION MADE: 05-OCT-00
CRUMLIN, CO. ANTRIM, IRELAND BT29 510(k) STATEMENT
DEVICE: REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)
REPROMEDIX CORP 510(k) NO: K001603(TRADITIONAL)
ATTN: HAN-SOO KIM PHONE NO : 781-667-8893
86 CUMMINGS PARK, SE DECISION MADE: 05-OCT-00
WOBURN, MA 01801 510(k) STATEMENT
DEVICE: REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)
REPROMEDIX CORP 510(k) NO: K001606(TRADITIONAL)
ATTN: HAN-SOO KIM PHONE NO : 781-667-8893
86 CUMMINGS PARK, SE DECISION MADE: 05-OCT-00
WOBURN, MA 01801 510(k) STATEMENT
DEVICE: REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
REPROMEDIX CORP 510(k) NO: K001607(TRADITIONAL)
ATTN: HAN-SOO KIM PHONE NO : 781-667-8893
86 CUMMINGS PARK, SE DECISION MADE: 05-OCT-00
WOBURN, MA 01801 510(k) STATEMENT
DEVICE: PDT DOSECALCULATOR, MODEL 80000
RETINALABS.COM 510(k) NO: K000418(TRADITIONAL)
ATTN: FRANK TIGHE PHONE NO : 800-793-1473
1776 PEACHTREE STREET SE DECISION MADE: 24-OCT-00
200 NORTH 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30309
DEVICE: RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERI
RIVERSTONE RESOURCES SDN. BHD. 510(k) NO: K003232(TRADITIONAL)
ATTN: CHONG CHU MEE PHONE NO : 603 636 8077
LOT 21909, NO.5, LORONG HELAN SE DECISION MADE: 26-OCT-00
HINDIK KEPONG BARU INDUST. EST 510(k) STATEMENT
KEPONG BARU, KUALA LUMPUR, MALAYSIA 52100
DEVICE: ELECSYS CA 15-3 TEST SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K001468(TRADITIONAL)
ATTN: PRISCILLA A HAMILL PHONE NO : 317-576-3723
9115 HAGUE RD. SE DECISION MADE: 23-OCT-00
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS DHEA-S CALSET
ROCHE DIAGNOSTICS CORP. 510(k) NO: K002760(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-576-3544
9115 HAGUE RD. SE DECISION MADE: 05-OCT-00
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q-LUX PLASMA 100 LIGHT CURE UNIT
ROLENCE ENTERPRISE CO. LTD. 510(k) NO: K001719(TRADITIONAL)
ATTN: STERLING CHENG PHONE NO : 886 346 31999
18-3 LANE 231 PU CHUNG RD. SE DECISION MADE: 10-OCT-00
CHUNGLI 320, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE
RONVIG INSTRUMENTS, LTD. 510(k) NO: K002168(ABBREVIATED)
ATTN: ANNETTE RAVN NEILSEN PHONE NO : 45 75 895711
GL.VEJLEVEJ 57-59 SE DECISION MADE: 13-OCT-00
DK-8721 DAUGAARD, DENMARK DK-8721 510(k) STATEMENT
DEVICE: PIPER
RTEK MEDICAL SYSTEMS, LLC 510(k) NO: K001295(TRADITIONAL)
ATTN: ROBERT C JACKSON PHONE NO : 716-249-0984
16 TOBEY VILLAGE OFFICE PARK SE DECISION MADE: 25-OCT-00
PITTSFORD, NY 14534 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE
SAGE BIOPHARMA 510(k) NO: K002836(SPECIAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 03-OCT-00
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM
SCIMEDX CORP. 510(k) NO: K002169(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 973-625-8822
400 FORD RD. SE DECISION MADE: 19-OCT-00
DENVILLE, NJ 07834 510(k) STATEMENT
DEVICE: GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM
SCIMEDX CORP. 510(k) NO: K002189(TRADITIONAL)
ATTN: GARY L EHNUS PHONE NO : 973-625-8822
400 FORD RD. SE DECISION MADE: 19-OCT-00
DENVILLE, NJ 07834 510(k) STATEMENT
DEVICE: MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM
SECTRA-IMTEC AB 510(k) NO: K002936(SPECIAL)
ATTN: HERMAN OOSTERWIJK PHONE NO : 940-440-9530
2001 EAST OAKSHORES DRIVE SE DECISION MADE: 17-OCT-00
CROSSROADS, TX 76227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVERNESS MEDICAL OVULATION PREDICTOR TEST
SELFCARE, INC. 510(k) NO: K002867(SPECIAL)
ATTN: CAROL A ADILETTO PHONE NO : 781-647-3900
200 PROSPECT ST. SE DECISION MADE: 12-OCT-00
WALTHAM, MA 02154-3457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
SHANGHAI PT PLASTICS ENTERPRISE CO510(k) NO: K002814(TRADITIONAL)
ATTN: CHANG T SUN PHONE NO : 862 157 814212
258 YUSHU RD. SE DECISION MADE: 20-OCT-00
CANGQIAO TOWNSHIP 510(k) STATEMENT
SHONGJIANG COUNTY, SHANGHAI, CHINA
DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
SHANGHAI PT PLASTICS ENTERPRISE CO510(k) NO: K002870(TRADITIONAL)
ATTN: PETER WANG PHONE NO : 011 862 157818521
NO. 258, YUSHU ROAD SE DECISION MADE: 16-OCT-00
CANGQIAO TOWNSHIP 510(k) STATEMENT
SONGJIANG COUNTY, SHANGHAI, CHINA
DEVICE: CATHCOR DESKTOP
SIEMENS ELEMA AB 510(k) NO: K002137(TRADITIONAL)
ATTN: DAVE SIMARD PHONE NO : 978-097-7737
ELECTROMEDICAL SYSTEMS GROUP SE DECISION MADE: 05-OCT-00
16 ELECTRONICS AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
DANVERS, MA 01923
DEVICE: MAGNETOM ALLEGRA SYSTEM
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K002179(TRADITIONAL)
ATTN: JAMIE YIEH PHONE NO : 732-321-4625
186 WOOD AVENUE SOUTH SE DECISION MADE: 11-OCT-00
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM EMOTION MS
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K003014(TRADITIONAL)
ATTN: KATHLEEN RUTHERFORD PHONE NO : 732-231-4779
186 WOOD AVENUE SOUTH SE DECISION MADE: 12-OCT-00
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K003125(TRADITIONAL)
ATTN: JUDI HOFFMAN PHONE NO : 425-557-1229
22010 S.E. 51ST ST. SE DECISION MADE: 20-OCT-00
ISSAQUAH, WA 98029-7002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM SMILE
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K003152(TRADITIONAL)
ATTN: KATHLEEN RUTHERFORD PHONE NO : 732-321-4779
186 WOOD AVENUE SOUTH SE DECISION MADE: 24-OCT-00
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN
SMART GLOVE CORP. SDN BHD 510(k) NO: K002568(TRADITIONAL)
ATTN: FOO K PU PHONE NO : 603 391 6100
LOT 6487 BATU 5 3/4 SE DECISION MADE: 03-OCT-00
JALAN KAPAR 510(k) STATEMENT
KLANG SELANGOR, MALAYSIA 42100
DEVICE: NEUROTOLOGY DRAPE, MODEL TBD
SMITH & NEPHEW ENT. 510(k) NO: K002702(TRADITIONAL)
ATTN: GREG SREDIN PHONE NO : 901-373-0200
2925 APPLING RD. SE DECISION MADE: 26-OCT-00
BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW PORPS & TORPS
SMITH & NEPHEW ENT. 510(k) NO: K002737(TRADITIONAL)
ATTN: ALICIA FARAGE PHONE NO : 901-373-0200
2925 APPLING RD. SE DECISION MADE: 12-OCT-00
BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW PISTONS
SMITH & NEPHEW ENT. 510(k) NO: K003214(TRADITIONAL)
ATTN: JEFFREY W COBB PHONE NO : 901-373-0200
2925 APPLING RD. SE DECISION MADE: 31-OCT-00
BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR-III
SMITH & NEPHEW, INC. 510(k) NO: K002261(TRADITIONAL)
ATTN: DEMETRIOS TSAKONAS PHONE NO : 508-261-3775
160 DASCOMB RD. SE DECISION MADE: 23-OCT-00
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPEEDLINK TRANSVERSE CONNECTOR
SPINAL CONCEPTS, INC. 510(k) NO: K002082(TRADITIONAL)
ATTN: DAVID M HOOPER PHONE NO : 512-918-2700
12012 TECHNOLOGY BLVD., #100 SE DECISION MADE: 06-OCT-00
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCEND SPINAL FIXATION SYSTEM
SPINAL INNOVATIONS, LLC 510(k) NO: K002069(TRADITIONAL)
ATTN: KEN RUSSELL PHONE NO : 901-373-8855
7850 STAGE HILLS BLVD. SE DECISION MADE: 05-OCT-00
SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA
BARTLETT, TN 38133
DEVICE: STACKHOUSE LENS HOOD, MODEL SA-700/FS
STACKHOUSE, INC. 510(k) NO: K003194(SPECIAL)
ATTN: TOM GUTIERREZ PHONE NO : 760-778-7255
1100 BIRD CENTER DR. SE DECISION MADE: 26-OCT-00
PALM SPRINGS, CA 92262 510(k) STATEMENT
DEVICE: STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR
STARION INSTRUMENTS 510(k) NO: K002547(TRADITIONAL)
ATTN: BRIAN GRIGSBY PHONE NO : 408-741-8773
20665 4TH ST. SE DECISION MADE: 20-OCT-00
SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLICITY DISPOSABLE PEN NEEDLE
STERLING MEDIVATIONS, INC. 510(k) NO: K002180(ABBREVIATED)
ATTN: JOEL DOUGLAS PHONE NO : 650-949-0407
180 FERNDALE ROAD SOUTH SE DECISION MADE: 13-OCT-00
WAYZATA, MN 55391 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLICITY SOFT INFUSION SET
STERLING MEDIVATIONS, INC. 510(k) NO: K002492(ABBREVIATED)
ATTN: JOEL DOUGLAS PHONE NO : 650-949-0470
180 FERNDALE ROAD SOUTH SE DECISION MADE: 24-OCT-00
WAYZATA, MN 55391 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER NAVIGATION SYSTEM - ENT MODULE
STRYKER CORP. 510(k) NO: K002732(TRADITIONAL)
ATTN: NICOLE PETTY PHONE NO : 616-323-7700
4100 EAST MILHAM AVENUE SE DECISION MADE: 02-OCT-00
KALAMAZOO, MI 49001-6197 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM
SUITER MEDICAL L.L.C. 510(k) NO: K002876(TRADITIONAL)
ATTN: JAMES P SUITER PHONE NO : 800-354-3450
203 WEST 2ND STREET SE DECISION MADE: 11-OCT-00
MC COOK, NE 69001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURAGARD SODIUM FLUORIDE VARNISH
SULTAN DENTAL PRODUCTS, LTD. 510(k) NO: K002581(TRADITIONAL)
ATTN: GEORGE WOLFE PHONE NO : 201-894-5500
242 SOUTH DEAN ST. SE DECISION MADE: 20-OCT-00
ENGLEWOOD, NJ 07631 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POL
SULZER ORTHOPEDICS, INC. 510(k) NO: K002335(TRADITIONAL)
ATTN: MITCHELL DHORITY PHONE NO : 512-432-9202
9900 SPECTRUM DR. SE DECISION MADE: 25-OCT-00
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS
SULZER ORTHOPEDICS, INC. 510(k) NO: K002356(TRADITIONAL)
ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9900
9900 SPECTRUM DR. SE DECISION MADE: 30-OCT-00
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206
SUN NUCLEAR CORP. 510(k) NO: K002444(TRADITIONAL)
ATTN: THOMAS L POWERS PHONE NO : 407-259-6862
425-A PINEDA COURT SE DECISION MADE: 18-OCT-00
MELBOURNE, FL 32940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
SUN NUCLEAR CORP. 510(k) NO: K002446(TRADITIONAL)
ATTN: THOMAS L POWERS PHONE NO : 407-259-6862
425-A PINEDA COURT SE DECISION MADE: 23-OCT-00
MELBOURNE, FL 32940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSCAR 2, MODEL 222
SUNTECH MEDICAL INSTRUMENTS, INC. 510(k) NO: K003004(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SE DECISION MADE: 25-OCT-00
HASBROUCK, NJ 07460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGI-VISION URETHRAL COIL
SURGI-VISION, INC. 510(k) NO: K002345(TRADITIONAL)
ATTN: NANCY E TAYLOR PHONE NO : 410-730-8998
9250 RUMSEY RD., SUITE 100 SE DECISION MADE: 11-OCT-00
COLUMBIA, MD 21045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIOCAMERAS EXTRACRANIAL SYSTEM
SURGICAL NAVIGATION TECHNOLOGIES, 510(k) NO: K000246(TRADITIONAL)
ATTN: ROGER WHITE PHONE NO : 303-439-9709
530 COMPTON STREET SE DECISION MADE: 20-OCT-00
BROOMFIELD, CO 80020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRE
SURGICAL SPECIALTIES CORP. 510(k) NO: K002849(TRADITIONAL)
ATTN: VIKKI M HOFFMAN PHONE NO : 610-404-1000
100 DENNIS DRIVE SE DECISION MADE: 18-OCT-00
READING, PA 19606-3776 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES USS (10.0MM SIDE OPENING SCREWS)
SYNTHES 510(k) NO: K003061(SPECIAL)
ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 30-OCT-00
P.O. BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1262
DEVICE: SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM
SYNTHES (USA) 510(k) NO: K002361(TRADITIONAL)
ATTN: BONNIE J SMITH PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 31-OCT-00
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: SYNTHES PROXIMAL HUMERAL NAIL
SYNTHES (USA) 510(k) NO: K002729(TRADITIONAL)
ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 06-OCT-00
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMALL STATURE USS
SYNTHES (USA) 510(k) NO: K994121(TRADITIONAL)
ATTN: JONATHAN M GILBERT PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 17-OCT-00
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100
TECNO INSTRUMENTS (PVT.) LTD. 510(k) NO: K002257(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 19-OCT-00
GREAT NECK,, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LITEAIRE
THAYER MEDICAL CORP. 510(k) NO: K993101(TRADITIONAL)
ATTN: DAVID T SLADEK PHONE NO : 520-790-5393
4575 SOUTH PALO VERDE RD., SE DECISION MADE: 26-OCT-00
SUITE 337 510(k) STATEMENT
TUCSON, AZ 85714
DEVICE: ANSPACH ANGLED MICRONOSE ATTACHMENT
THE ANSPACH EFFORT, INC. 510(k) NO: K002903(TRADITIONAL)
ATTN: WILLIAM E ANSPACH III PHONE NO : 561-627-1080
4500 RIVERSIDE DR. SE DECISION MADE: 24-OCT-00
PALM BEACH GARDENS, FL 33410 510(k) STATEMENT
DEVICE: SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
THE BINDING SITE, LTD. 510(k) NO: K002560(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 26-OCT-00
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT
THE BINDING SITE, LTD. 510(k) NO: K002561(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 26-OCT-00
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KI
THE BINDING SITE, LTD. 510(k) NO: K002563(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 26-OCT-00
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
THE BINDING SITE, LTD. 510(k) NO: K002564(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 26-OCT-00
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: REFACTO LABORATORY STANDARD
THE GENETICS INSTITUTE 510(k) NO: K002350(TRADITIONAL)
ATTN: MARYANN KRANE PHONE NO : 617-665-8737
87 CAMBRIDGE PARK DRIVE SE DECISION MADE: 05-OCT-00
CAMBRIDGE, MA 02140-2387 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM
TISSUE MEDICAL LASERS, INC. 510(k) NO: K000317(TRADITIONAL)
ATTN: DWIGHT ZURAWSKI PHONE NO : 505-828-0508
4432 ANAHEIM AVE., N.E. SE DECISION MADE: 27-OCT-00
ALBUQUERQUE, NM 87113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORNIER TOTAL ELBOW PROSTHESIS
TORNIER S.A. 510(k) NO: K000003(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 02-OCT-00
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389
DEVICE: 3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K002424(TRADITIONAL)
ATTN: DIANA THORSON PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 27-OCT-00
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068
DEVICE: OPART, MODEL MRT-600
TOSHIBA AMERICA MRI, INC. 510(k) NO: K002522(TRADITIONAL)
ATTN: BRUCE CLARK PHONE NO : 650-872-2722
280 UTAH AVE. SE DECISION MADE: 25-OCT-00
SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3
TOSHIBA AMERICA MRI, INC. 510(k) NO: K002531(TRADITIONAL)
ATTN: KEN NEHMER PHONE NO : 650-872-2722
280 UTAH AVE. SE DECISION MADE: 26-OCT-00
SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRV2000 INDIVIDUAL RECREATIONAL VEHICLE
TRAC ABOUT, INC. 510(k) NO: K001835(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
777 S. WADSWORTH BLVD. SE DECISION MADE: 11-OCT-00
BLDG.2. STE. 102 510(k) STATEMENT
LAKEWOOD, CO 80226
DEVICE: TUTOPATCH
TUTOGEN MEDICAL U.S., INC. 510(k) NO: K991296(TRADITIONAL)
ATTN: PJ PARDO PHONE NO : 904-462-2178
13709 PROGRESS BLVD. SE DECISION MADE: 06-OCT-00
BOX 19 510(k) SUMMARY AVAILABLE FROM FDA
ALACHUA, FL 32615
DEVICE: AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT
UNILENS CORP., USA 510(k) NO: K002408(TRADITIONAL)
ATTN: CHARLOTTE B COUECOU PHONE NO : 727-544-2531
10431 72ND ST. NORTH SE DECISION MADE: 17-OCT-00
LARGO, FL 33777 510(k) STATEMENT
DEVICE: UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED
UNITED CHAIR MFG., LLC 510(k) NO: K002318(TRADITIONAL)
ATTN: DOUGLAS A HANBY PHONE NO : 614-759-7333
2097 SOUTH HAMILTON ROAD SE DECISION MADE: 11-OCT-00
SUITE 109 510(k) STATEMENT
COLUMBUS, OH 43232
DEVICE: SPIRIT ACUPUNCTURE NEEDLE
UNITED PACIFIC CO., LTD. 510(k) NO: K003010(TRADITIONAL)
ATTN: DANIEL YE HUA PHONE NO : 626-458-8518
219 SOUTH RAYMOND AVE SE DECISION MADE: 19-OCT-00
ALHAMBRA, CA 91801 510(k) STATEMENT
DEVICE: VISION 9000 PHASED ARRAY TORSO COIL
USA INSTRUMENTS, INC. 510(k) NO: K002482(TRADITIONAL)
ATTN: RONY THOMAS PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 17-OCT-00
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWER 5000 GENERAL PURPOSE COIL
USA INSTRUMENTS, INC. 510(k) NO: K002483(TRADITIONAL)
ATTN: RONY THOMAS PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 25-OCT-00
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PACIFIER THERMOMETER MODELS VT-901F, VT901C
VALEO CORP. 510(k) NO: K002562(TRADITIONAL)
ATTN: MARIAN HARDING COCHRAN PHONE NO : 954-779-2500
501 SOUTH ANDREWS AVENUE SE DECISION MADE: 13-OCT-00
FT. LAUDERDALE, FL 33301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISIJET HYDROKERATOME, MODEL 50
VISIJET, INC. 510(k) NO: K991124(TRADITIONAL)
ATTN: JUDY F GORDON PHONE NO : 949-854-6314
18732 SAGINAW SE DECISION MADE: 20-OCT-00
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITREA 2, VERSION 2.1
VITAL IMAGES, INC. 510(k) NO: K002519(TRADITIONAL)
ATTN: ROBERT C SAMEC PHONE NO : 612-915-8001
3300 FERNBROOK LANE NORTH SE DECISION MADE: 19-OCT-00
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55447
DEVICE: AERONEB PORTABLE NEBULIZER
VOGUE SHOPS, INC. 510(k) NO: K003022(TRADITIONAL)
ATTN: TRACI V.A. EDWARDS PHONE NO : 408-543-2414
6225 POWERS AVE. SE DECISION MADE: 13-OCT-00
JACKSONVILLE, FL 32217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTICOAT 7 DRESSING
WESTAIM BIOMEDICAL INC. 510(k) NO: K001519(TRADITIONAL)
ATTN: STEVE CHARTIER PHONE NO : 603-775-7300
ONE HAMPTON RD., SUITE 302 SE DECISION MADE: 06-OCT-00
EXETER, NH 03833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STE
WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K002975(TRADITIONAL)
ATTN: MOHD HAIZAN HUSSEIN PHONE NO : 60 387 069788
LOT11, JL.2,KAWASAN PERUSAHAAN SE DECISION MADE: 24-OCT-00
BANDAR BARU SLAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA
SELANGOR DAURL EHSAN, SEPANG, MALAYSIA 43900
DEVICE: XPS NITRO SYSTEM
XOMED, INC. 510(k) NO: K002828(TRADITIONAL)
ATTN: MARTIN D SARGENT PHONE NO : 904-279-7586
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 17-OCT-00
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM MIDDLE EAR PROSTHESES
XOMED, INC. 510(k) NO: K002897(TRADITIONAL)
ATTN: DAVID TIMLIN PHONE NO : 904-279-7532
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 11-OCT-00
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 288
TOTAL WITH SUMMARIES 212
TOTAL WITH STATEMENTS 76
Updated 4/10/2001
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