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510(k)s Final Decisions Rendered for August 2002 |
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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-AUG-2002 THROUGH 31-AUG-2002
DEVICE: RELYX RMGIP
3M COMPANY 510(k) NO: K022476(SPECIAL)
ATTN: KAREN O'MALLEY PHONE NO : 651-736-7326
3M CENTER, BLDG. 260-2B-12 SE DECISION MADE: 02-AUG-02
ST PAUL, MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINPRO PROPHY POWDER
3M ESPE AG DENTAL PRODUCTS 510(k) NO: K021450(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 01-AUG-02
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3T VESSEL CANNULAS
3T MEDICAL SYSTEMS, LLC. 510(k) NO: K020768(TRADITIONAL)
ATTN: ROBERT P EATON PHONE NO : 303-838-2407
12553 S. WAMBLEE VALLEY ROAD SE DECISION MADE: 23-AUG-02
CONIFER, CO 80433-6204 510(k) STATEMENT
DEVICE: ALLGRAD 45 AND 90 CELL SEPARATION MEDIA
INTL., INC. 510(k) NO: K022330(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW ROAD SE DECISION MADE: 26-AUG-02
GUILFORD, CT 06443 510(k) STATEMENT
DEVICE: LITE MINERAL OIL
INTL., INC. 510(k) NO: K022332(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW ROAD SE DECISION MADE: 23-AUG-02
GUILFORD, CT 06443 510(k) STATEMENT
DEVICE: HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS
INTL., INC. 510(k) NO: K022334(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW ROAD SE DECISION MADE: 28-AUG-02
GUILFORD, CT 06443 510(k) STATEMENT
DEVICE: ALLGRAD AND ALLGRAD100
INTL., INC. 510(k) NO: K022335(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW ROAD SE DECISION MADE: 23-AUG-02
GUILFORD, CT 06443 510(k) STATEMENT
DEVICE: HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)
INTL., INC. 510(k) NO: K022352(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW ROAD SE DECISION MADE: 28-AUG-02
GUILFORD, CT 06443 510(k) STATEMENT
DEVICE: ACIDIFIED TYRODES SOLUTION
INTL., INC. 510(k) NO: K022547(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW ROAD SE DECISION MADE: 28-AUG-02
GUILFORD, CT 06437 510(k) STATEMENT
DEVICE: PVP (POLYVINYLPYRROLIDONE)
INTL., INC. 510(k) NO: K022590(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW ROAD SE DECISION MADE: 30-AUG-02
GUILFORD, CT 06437 510(k) STATEMENT
DEVICE: LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
A-MED SYSTEMS, INC. 510(k) NO: K020529(TRADITIONAL)
ATTN: CYNTHIA G ROYSTER PHONE NO : 916-375-7400
2491 BOATMAN AVE. SE DECISION MADE: 26-AUG-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BNF
AAP IMPLANTATE AG 510(k) NO: K021782(TRADITIONAL)
ATTN: DIPL-ING CHRISTIAN ABEL PHONE NO : 493 075 019190
LORENZWEG 5 SE DECISION MADE: 26-AUG-02
BERLIN, GERMANY 12099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASU
ABBOTT LABORATORIES 510(k) NO: K021960(TRADITIONAL)
ATTN: JANET S CONNOLLY PHONE NO : 781-276-6230
4-A CROSBY DR. SE DECISION MADE: 16-AUG-02
BEDFORD, MA 01730-1402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
ABBOTT LABORATORIES 510(k) NO: K022203(SPECIAL)
ATTN: FRANK POKROP PHONE NO : 847-937-8473
DEPT 0389 BLDG J-45 SE DECISION MADE: 01-AUG-02
200 ABBOTT PARK ROAD 510(k) SUMMARY AVAILABLE FROM FDA
ABBOTT PARK, IL 60064-6133
DEVICE: ACCESSAED, MODEL 9100-0300
ACCESS CARDIOSYSTEMS, INC. 510(k) NO: K020984(TRADITIONAL)
ATTN: DAVID BARASH PHONE NO : 978-371-4985
150 BAKER AVENUE EXTENSION SE DECISION MADE: 14-AUG-02
SUITE 108 510(k) SUMMARY AVAILABLE FROM FDA
CONCORD, MA 01742
DEVICE: ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC
ACMI CORPORATION 510(k) NO: K022480(SPECIAL)
ATTN: JOHN A DELUCIA PHONE NO : 508-804-2617
136 TURNPIKE ROAD SE DECISION MADE: 22-AUG-02
SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM
ACUSON CORP. 510(k) NO: K022567(TRADITIONAL)
ATTN: JERRY W TSUTSUMI PHONE NO : 650-943-7286
1220 CHARLESTON RD. SE DECISION MADE: 13-AUG-02
MOUNTAIN VIEW, CA 94039-7393 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES
ACUTRONIC MEDICAL SYSTEMS AG 510(k) NO: K012693(TRADITIONAL)
ATTN: TERRY TORZALA PHONE NO : 520-743-7874
PO BOX 85820 SE DECISION MADE: 01-AUG-02
TUCSON, AZ 85754-5820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTITATIVE BLOOD POOL SPECT (QBS)
ADAC LABORATORIES 510(k) NO: K022428(TRADITIONAL)
ATTN: COLEEN COLEMAN PHONE NO : 408-468-3051
540 ALDER DR. SE DECISION MADE: 06-AUG-02
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ALPHA INFUSION PUMP AND CATHETERS
ADVANCED INFUSION, INC. 510(k) NO: K021964(TRADITIONAL)
ATTN: JAMES CHRISTENSEN PHONE NO : 909-305-9857
6200 SOUTH MCCLINTOCK #6 SE DECISION MADE: 12-AUG-02
TEMPE, AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAMITRODE S-SERIES (S4 AND S8) LEADS
ADVANCED NEUROMODULATION SYSTEM,IN510(k) NO: K022222(SPECIAL)
ATTN: KATRYNA WARREN PHONE NO : 972-309-8000
6501 WINDCREST DRIVE,SUTE 100 SE DECISION MADE: 08-AUG-02
PLANO, TX 75024 510(k) STATEMENT
DEVICE: APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K013003(TRADITIONAL)
ATTN: NATALIE BENNINGTON PHONE NO : 949-453-6482
33 TECHNOLOGY DR. SE DECISION MADE: 28-AUG-02
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP
ADVEN MEDICAL 510(k) NO: K021528(TRADITIONAL)
ATTN: MARK W ALDANA PHONE NO : 806-745-7718
1001 SLATON HWY. SE DECISION MADE: 21-AUG-02
LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AART SILICONE SHEETING
AESTHETIC AND RECONSTRUCTIVE TECHN510(k) NO: K022223(TRADITIONAL)
ATTN: CATHERINE RIPLE PHONE NO : 805-239-1059
5871 LONE PINE PLACE SE DECISION MADE: 08-AUG-02
PASO ROBLES, CA 93446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AART CALF IMPLANT
AESTHETIC AND RECONSTRUCTIVE TECHN510(k) NO: K022511(TRADITIONAL)
ATTN: CATHERINE RIPLE PHONE NO : 805-239-1059
5871 LONE PINE PLACE SE DECISION MADE: 26-AUG-02
PASO ROBLES, CA 93446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADC DENTAL
AGFA CORP. 510(k) NO: K021542(TRADITIONAL)
ATTN: JEFF JEDLICKA PHONE NO : 864-421-1815
10 SOUTH ACADEMY STREET SE DECISION MADE: 06-AUG-02
GREENVILLE, SC 29602 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MEDSTATION
AISOFTW@RE MEDICAL, S.P.A. 510(k) NO: K021934(TRADITIONAL)
ATTN: DIANA UPTON PHONE NO : 201-692-1945
719 CATALPA AVE SE DECISION MADE: 12-AUG-02
TEANECK, NJ 07666 510(k) STATEMENT
DEVICE: ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
ALARIS MEDICAL SYSTEMS, INC. 510(k) NO: K022209(SPECIAL)
ATTN: RENNE L FLUET PHONE NO : 858-458-7563
10221 WATERIDGE CIRCLE SE DECISION MADE: 06-AUG-02
SAN DIEGO, CA 92121-2772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
ALCON UNIVERSAL, LTD. 510(k) NO: K021143(TRADITIONAL)
ATTN: RALPH H LARSEN PHONE NO : 817-551-4702
6201 SOUTH FREEWAY SE DECISION MADE: 08-AUG-02
FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K022564(SPECIAL)
ATTN: NAISHU WANG PHONE NO : 858-513-3888
12330 STOWE DRIVE SE DECISION MADE: 30-AUG-02
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLY STAT HCG DIPSTICK TEST
ALIDEX, INC. 510(k) NO: K021386(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 425-814-1514
12277 134TH CT., N.E., #100 SE DECISION MADE: 05-AUG-02
REDMOND, WA 98052 510(k) STATEMENT
DEVICE: GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYST
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K012931(TRADITIONAL)
ATTN: LANCE MARCONI PHONE NO : 847-785-3312
1500 WAUKEGAN RD. SE DECISION MADE: 20-AUG-02
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROPHYSIOLOGY CATHETER
ALLIANCE MEDICAL CORP. 510(k) NO: K012708(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 480-763-5300
10232 SOUTH 51ST. STREET SE DECISION MADE: 13-AUG-02
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALPHA DRIVE SYSTEM
ALPHA OMEGA LTD. 510(k) NO: K013396(SPECIAL)
ATTN: AJWAD AKASHI PHONE NO : 972 465 63327
HA'AVODA ST., P.O. BOX 810 SE DECISION MADE: 07-AUG-02
NAZARETH ILLIT, ISRAEL 17105 510(k) STATEMENT
DEVICE: SCREWLINE
ALTATEC BIOTECHNOLOGIES N.A., INC.510(k) NO: K022425(SPECIAL)
ATTN: ROBERT J SLOMOFF PHONE NO : 301-983-1707
9229 CRANFORD DRIVE SE DECISION MADE: 14-AUG-02
POTOMAC, MD 20854 510(k) STATEMENT
DEVICE: ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S &
ANDERSEN PRODUCTS, INC. 510(k) NO: K021493(SPECIAL)
ATTN: WENDY HEDRICK PHONE NO : 336-376-3000
3202 CAROLINE DR., SE DECISION MADE: 30-AUG-02
HEALTH SCIENCE PARK 510(k) SUMMARY AVAILABLE FROM FDA
HAW RIVER, NC 27258-8710
DEVICE: BABY TEETHER, MODEL 20104
ANGELINA TRADING, INC. 510(k) NO: K014023(TRADITIONAL)
ATTN: JOHN CHANG PHONE NO : 213-362-0899
947 S. ALAMEDA STREET #A SE DECISION MADE: 02-AUG-02
LOS ANGELES, CA 90021 510(k) STATEMENT
DEVICE: MODIFICATION TO INSTA CHECK MULTI-DRUG SCREEN PANEL THC/COC.MOR
APPLIED BIOTECH, INC. 510(k) NO: K022392(SPECIAL)
ATTN: DOUG HARDING PHONE NO : 858-587-6771
10237 FLANDERS CT. SE DECISION MADE: 15-AUG-02
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC O
ARGUS BIOMEDICAL PTY LTD 510(k) NO: K013756(TRADITIONAL)
ATTN: BARBARA S FANT PHONE NO : 513-961-8200
3307 CLIFTON AVE., SE DECISION MADE: 29-AUG-02
CINCINNATI, OH 45220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHEATH ADAPTER, MODEL SA-09847
ARROW INTL., INC. 510(k) NO: K021723(TRADITIONAL)
ATTN: BRANDON EPTING PHONE NO : 610-378-0131
2400 BERNVILLE RD. SE DECISION MADE: 08-AUG-02
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTERIA BLOOD FILTER
ARTERIA MEDICAL SCIENCE, INC. 510(k) NO: K021293(TRADITIONAL)
ATTN: ALAN HINTON PHONE NO : 707-422-1778
22 HILL ST. SE DECISION MADE: 22-AUG-02
NEWBURYPORT, MA 01950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
ARTHROCARE CORP. 510(k) NO: K022543(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 30-AUG-02
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALMO THERMOREGULATION INTERFACE ACCESSORY
AVACORE TECHNOLOGIES, INC. 510(k) NO: K014210(TRADITIONAL)
ATTN: CRAIG COOMBS PHONE NO : 415-531-1932
251 HIGH STREET, SUITE B SE DECISION MADE: 16-AUG-02
PALO ALTO, CA 94301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASTIM KIT
AXELGAARD MFG. CO., LTD. 510(k) NO: K013532(TRADITIONAL)
ATTN: DAN JEFFERY PHONE NO : 760-723-7554
1667 S. MISSION ROAD SE DECISION MADE: 22-AUG-02
FALLBROOK, CA 92028-4115 510(k) STATEMENT
DEVICE: INTROCAN SAFETY IV CATHETER
B. BRAUN MEDICAL, INC. 510(k) NO: K020785(TRADITIONAL)
ATTN: AMY S KRALL PHONE NO : 610-266-0500
824 TWELFTH AVE. SE DECISION MADE: 28-AUG-02
BETHLEHEM, PA 18018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIFIX CATHETER CONNECTOR
B. BRAUN MEDICAL, INC. 510(k) NO: K022019(TRADITIONAL)
ATTN: AMY S KRALL PHONE NO : 610-266-0500
901 MARCON BLVD. SE DECISION MADE: 01-AUG-02
ALLENTOWN, PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERFUSOR COMPACT WITH FM SYSTEM
B. BRAUN MEDICAL, INC. 510(k) NO: K022575(TRADITIONAL)
ATTN: LINDA MORGAN PHONE NO : 972-245-2243
1601 WALLACE DR., SUITE 150 SE DECISION MADE: 21-AUG-02
CARROLLTON, TX 75006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LEN
BAUSCH & LOMB INCORPORATED 510(k) NO: K022128(TRADITIONAL)
ATTN: DEBRA L KETCHUM PHONE NO : 585-338-8638
1400 NORTH GOODMAN STREET SE DECISION MADE: 22-AUG-02
ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPID-FILL TUBESET, MODEL 90005
BAXA CORP. 510(k) NO: K022523(TRADITIONAL)
ATTN: KARL STEINBECK PHONE NO : 303-617-2181
13760 EAST ARAPAHOE RD. SE DECISION MADE: 12-AUG-02
ENGLEWOOD, CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION S
BECTON DICKINSON & CO. 510(k) NO: K022426(SPECIAL)
ATTN: M. WENDY BOSSHARDT PHONE NO : 201-847-6280
1 BECTON DRIVE SE DECISION MADE: 08-AUG-02
FRANKLIN LAKES, NJ 07417-1880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MC
BECTON, DICKINSON AND COMPANY 510(k) NO: K021954(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 01-AUG-02
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
BECTON, DICKINSON AND COMPANY 510(k) NO: K022172(TRADITIONAL)
ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778
7 LOVETON CIR. SE DECISION MADE: 12-AUG-02
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN)
BEST MANUFACTURING COMPANY 510(k) NO: K022024(TRADITIONAL)
ATTN: DAVID C YOUNG PHONE NO : 706-862-2302
579 EDISON STREET SE DECISION MADE: 01-AUG-02
MENLO, GA 30731 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SER
BIO-RAD 510(k) NO: K022525(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 15-AUG-02
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIE
BIO-RAD 510(k) NO: K022529(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1200
9500 JERONIMO ROAD SE DECISION MADE: 15-AUG-02
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S
BIO-RAD 510(k) NO: K022707(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO ROAD SE DECISION MADE: 22-AUG-02
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE AUTOTAC SYSTEM TITANIUM TACK
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K022790(SPECIAL)
ATTN: WINSTON GREER PHONE NO : 205-967-7880
ONE PERIMETER PARK SOUTH SE DECISION MADE: 28-AUG-02
SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
BIRMINGHAM, AL 35243
DEVICE: MODIFICATION TO THE MAESTRO SYSTEM
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K022795(SPECIAL)
ATTN: WINSTON GREER PHONE NO : 205-967-7880
ONE PERIMETER PARK SOUTH SE DECISION MADE: 30-AUG-02
SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
BIRMINGHAM, AL 35243
DEVICE: CERALAS D DIODE LASER SYSTEM, MODEL # D50
BIOLITEC, INC. 510(k) NO: K013691(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST., NW SE DECISION MADE: 13-AUG-02
WASHINGTON, DC 20004-5910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLEEPFLO, MODEL 101501
BIOMEC, , INC. 510(k) NO: K020607(ABBREVIATED)
ATTN: TRACEY H WIELINSKI PHONE NO : 216-937-2800
1771 EAST 30TH STREET SE DECISION MADE: 30-AUG-02
CLEVELAND, OH 44114-4407 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDA D-DIMER
BIOMERIEUX, INC. 510(k) NO: K021877(TRADITIONAL)
ATTN: RON SANYAL PHONE NO : 919-620-2373
100 RODOLPHE STREET SE DECISION MADE: 07-AUG-02
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID
BIOMERIEUX, INC. 510(k) NO: K022045(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM ROAD SE DECISION MADE: 15-AUG-02
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED P
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K022463(SPECIAL)
ATTN: DALENE T BINKLEY PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 16-AUG-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTERIOR STABILIZED TIBIAL BEARINGS
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K022586(SPECIAL)
ATTN: DALENE T BINKLEY PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 15-AUG-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM ANKLE ARTHRODESIS NAIL
BIOMET, INC. 510(k) NO: K021786(TRADITIONAL)
ATTN: LONNIE WITHAM PHONE NO : 219-267-6639
56 EAST BELL DR. SE DECISION MADE: 26-AUG-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2MM PEDIATRIC FLEX NAIL
BIOMET, INC. 510(k) NO: K022531(SPECIAL)
ATTN: TRACY J BICKEL PHONE NO : 574-267-6639
56 BELL DRIVE SE DECISION MADE: 26-AUG-02
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: BIOTEST HEMOGLOBIN MEASURING SYSTEM
BIOTEST MEDIZINTECHNIK GMBH 510(k) NO: K020710(ABBREVIATED)
ATTN: MARK LICATA PHONE NO : 804-828-9329
614 N 4TH STREET SE DECISION MADE: 14-AUG-02
RICHMOND, VA 23219 510(k) STATEMENT
DEVICE: UNINHIBITED
BISCO, INC. 510(k) NO: K021503(TRADITIONAL)
ATTN: STEPHEN (STEVE) SMITH PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 01-AUG-02
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE SPINAL FIXATION SYSTEM SPACER
BLACKSTONE MEDICAL, INC. 510(k) NO: K022399(SPECIAL)
ATTN: ALAN LOMBARDO PHONE NO : 973-633-9968
90 BROOKSDALE DR. SE DECISION MADE: 06-AUG-02
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER
BLACKSTONE MEDICAL, INC. 510(k) NO: K022605(SPECIAL)
ATTN: ALAN LOMBARDO PHONE NO : 973-633-9968
90 BROOKDALE DR. SE DECISION MADE: 21-AUG-02
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOLTON PTA CATHETER
BOLTON MEDICAL, INC. 510(k) NO: K021996(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-797-0014
16-00 POLLITT DR. SE DECISION MADE: 23-AUG-02
FAIR LAWN, NJ 07410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URETERAL STENT
BOSTON SCIENTIFIC CORP. 510(k) NO: K013784(TRADITIONAL)
ATTN: JANET A MCGRATH PHONE NO : 508-652-8726
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 08-AUG-02
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PRO
BOSTON SCIENTIFIC CORP. 510(k) NO: K020120(TRADITIONAL)
ATTN: PAIGE SWEENEY PHONE NO : 508-652-5560
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 02-AUG-02
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR SE MICROSPHERES
BOSTON SCIENTIFIC CORP. 510(k) NO: K022427(SPECIAL)
ATTN: JODI LYNN GREENIZEN PHONE NO : 518-742-4338
10 GLENS FALLS TECHNICAL PARK SE DECISION MADE: 22-AUG-02
DIX AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
GLENS FALLS, NY 12801-3864
DEVICE: BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC SCIMED, INC. 510(k) NO: K021735(TRADITIONAL)
ATTN: CANDICE BURNS PHONE NO : 763-494-2845
ONE SCIMED PLACE SE DECISION MADE: 08-AUG-02
MAPLE GROVE, MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOYD DELIVERY UNIT
BOYD INDUSTRIES, INC. 510(k) NO: K020833(TRADITIONAL)
ATTN: BRUCE LIVINGSTON PHONE NO : 727-561-9292
12900 44TH STREET NORTH SE DECISION MADE: 08-AUG-02
CLEARWATER, FL 33762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTIMA SNORING MIKE, MODEL 0540
BRAEBON MEDICAL CORP. 510(k) NO: K020312(TRADITIONAL)
ATTN: RICHARD A BONATO PHONE NO : 613 831 6690
120 WALGREEN DRIVE SE DECISION MADE: 07-AUG-02
SUITE 1 510(k) STATEMENT
RR#3 CARP, ONTARIO, CANADA KOA 1LO
DEVICE: PATXFER
BRAINLAB AG 510(k) NO: K021583(TRADITIONAL)
ATTN: STEFAN VILSMEIER PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8 SE DECISION MADE: 12-AUG-02
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSSEOUS IMPLANT
BRANEMARK INTEGRATION AB 510(k) NO: K021355(TRADITIONAL)
ATTN: RICKARD BRANEMARK PHONE NO : 460 317 601060
LILLA BOMMEN 1 SE DECISION MADE: 30-AUG-02
GOTBORG, SWEDEN SE-411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRESAGEN CATHETER, MODEL CS-3000
BRESAGEN, INC. 510(k) NO: K021481(TRADITIONAL)
ATTN: JOHN KUCHARCZYK PHONE NO : 706-613-9878
111 RIVER BEND ROAD SE DECISION MADE: 06-AUG-02
ATHENS, GA 30605 510(k) STATEMENT
DEVICE: BRUNO ELECTRA-RIDE, MODEL SRE-2700
BRUNO INDEPENDENT LIVING AIDS, INC510(k) NO: K022509(SPECIAL)
ATTN: RICHARD KELLER PHONE NO : 262-953-5336
1780 EXECUTIVE DRIVE SE DECISION MADE: 13-AUG-02
P.O. BOX 84 510(k) STATEMENT
OCONOMOWOC, WI 53066
DEVICE: BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
C.R. BARD, INC. 510(k) NO: K022350(TRADITIONAL)
ATTN: BRIAN A KANERVIKO PHONE NO : 401-463-7000
100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 23-AUG-02
P.O. BOX 8500 510(k) SUMMARY AVAILABLE FROM FDA
CRANSTON, RI 02920
DEVICE: BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
C.R. BARD, INC. 510(k) NO: K022434(TRADITIONAL)
ATTN: BETH A ZIS PHONE NO : 978-262-4866
129 CONCORD ROAD SE DECISION MADE: 05-AUG-02
BUILDING 3 510(k) SUMMARY AVAILABLE FROM FDA
BILLERICA, MA 01821 THIRD PARTY REVIEW
DEVICE: CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
C.R. BARD, INC. 510(k) NO: K022561(TRADITIONAL)
ATTN: PEGGY KEIFFER PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 23-AUG-02
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F 900
C.S.O. S.R.L. 510(k) NO: K022054(TRADITIONAL)
ATTN: R. BRENT MINER PHONE NO : 716-632-1988
197 BELVOIR ROAD SE DECISION MADE: 06-AUG-02
WILLIAMSVILLE, NY 14221 510(k) STATEMENT
DEVICE: C.T.M. POWER CHAIR, MODEL HS-2800
C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K021617(TRADITIONAL)
ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651
3636 E. COLUMBINE DRIVE SE DECISION MADE: 02-AUG-02
PHOENIX, AZ 85032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALMLIGHT
CAO GROUP, INC. 510(k) NO: K020057(TRADITIONAL)
ATTN: TRACY S BEST PHONE NO : 801-256-9282
8685 SOUTH 7TH WEST SE DECISION MADE: 27-AUG-02
SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRC-15BT
CAPINTEC, INC. 510(k) NO: K020150(TRADITIONAL)
ATTN: MARY ANNE DELL PHONE NO : 412-963-1988
540 ALPHA DR. SE DECISION MADE: 02-AUG-02
PITTSBURGH, PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K021574(TRADITIONAL)
ATTN: ALEX GONOROVSKY PHONE NO : 972 894 84600
2 PEKERIS ST. SE DECISION MADE: 12-AUG-02
PO BOX 527 510(k) SUMMARY AVAILABLE FROM FDA
REHOVOT, ISRAEL 76100
DEVICE: NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS
CARDIOMED SUPPLIES, INC. 510(k) NO: K021080(TRADITIONAL)
ATTN: DONNA MCCOMB PHONE NO : 905 888 1965
5 GORMLEY INDUSTRIAL AVENUE SE DECISION MADE: 29-AUG-02
GORMLEY, ONTARIO, CANADA L0H 1G0 510(k) STATEMENT
DEVICE: CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
CARDIOMEDICS, INC. 510(k) NO: K022107(TRADITIONAL)
ATTN: GARY CLARK PHONE NO : 949-863-2500
18872 BARDEEN AVE. SE DECISION MADE: 08-AUG-02
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENOXAPARIN TEST CARD
CARDIOVASCULAR DIAGNOSTICS, INC. 510(k) NO: K013305(TRADITIONAL)
ATTN: PETER SCOTT PHONE NO : 800-247-4234
9401 GLOBE CENTER DR. SE DECISION MADE: 23-AUG-02
SUITE 140 510(k) SUMMARY AVAILABLE FROM FDA
MORRISVILLE, NC 27560
DEVICE: EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, IN
CHAY MEDICAL, LLC. 510(k) NO: K021781(TRADITIONAL)
ATTN: STEPHEN C PEARSON PHONE NO : 707-481-3204
3257 ROUTE 128 SE DECISION MADE: 30-AUG-02
CALISTOGA, CA 94515 510(k) STATEMENT
DEVICE: CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3
CLINIQA CORPORATION 510(k) NO: K022232(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION ROAD SE DECISION MADE: 01-AUG-02
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SY
CLINIQA CORPORATION 510(k) NO: K022491(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION ROAD SE DECISION MADE: 27-AUG-02
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: REPHRESH VAGINAL GEL
COLUMBIA LABORATORIES, INC. 510(k) NO: K021737(TRADITIONAL)
ATTN: SUSAN A WITHAM PHONE NO : 973-994-3999
100 NORTH VILLAGE AVENUE SE DECISION MADE: 26-AUG-02
SUITE 32 510(k) STATEMENT
ROCKVILLE CENTRE, NY 11570
DEVICE: SURGISIS STAPLE LINE REINFORCEMENT
COOK BIOTECH, INC. 510(k) NO: K022044(TRADITIONAL)
ATTN: MARK BLEYER PHONE NO : 765-497-3355
3055 KENT AVE. SE DECISION MADE: 23-AUG-02
WEST LAFAYETTE, IN 47906-1076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYDNEY IVF CULTURE OIL
COOK UROLOGICAL, INC. 510(k) NO: K022002(TRADITIONAL)
ATTN: BRENDA DAVIS PHONE NO : 812-829-6500
1100 WEST MORGAN ST. SE DECISION MADE: 12-AUG-02
P.O. BOX 227 510(k) SUMMARY AVAILABLE FROM FDA
SPENCER, IN 47460
DEVICE: 7.0 FR. ENDOBRONCHIAL BLOCKER
COOK, INC. 510(k) NO: K021920(SPECIAL)
ATTN: APRIL LAVENDER PHONE NO : 800-468-1379
P.O. BOX 489 SE DECISION MADE: 14-AUG-02
BLOOMINGTON, IN 47402-0489 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
CORDIS CORP. 510(k) NO: K021898(SPECIAL)
ATTN: SAM MIRZA PHONE NO : 786-313-2007
14201 N.W. 60TH AVE. SE DECISION MADE: 14-AUG-02
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 507EL VITAL SIGNS MONITOR
CRITICARE SYSTEMS, INC. 510(k) NO: K022435(SPECIAL)
ATTN: ALEX KAPLAN PHONE NO : 262-798-8282
20925 CROSSROADS CIRCLE SE DECISION MADE: 14-AUG-02
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECAT VISION PET SCANNER, MODELS 3000 & 5000
CTI PET SYSTEMS, INC. 510(k) NO: K021633(TRADITIONAL)
ATTN: WILLIAM SKREMSKY PHONE NO : 865-218-2522
810 INNOVATION DR. SE DECISION MADE: 14-AUG-02
KNOXVILLE, TN 37932-2571 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420
CURELIGHT LTD 510(k) NO: K013623(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 16-AUG-02
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTEIN S AC
DADE BEHRING, INC. 510(k) NO: K022290(TRADITIONAL)
ATTN: DONNA A WOLF PHONE NO : 302-631-0384
514 GBC DRIVE SE DECISION MADE: 27-AUG-02
NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170
DATASCOPE CORP. 510(k) NO: K020550(TRADITIONAL)
ATTN: RUSSELL OLSEN PHONE NO : 201-995-8391
800 MACARTHUR BLVD. SE DECISION MADE: 28-AUG-02
MAHWAH, NJ 07430-0619 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA HMEF 500
DATEX-OHMEDA 510(k) NO: K021265(TRADITIONAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 30-AUG-02
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02
DATEX-OHMEDA 510(k) NO: K022507(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 23-AUG-02
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMOD
DAYTON WATER SYSTEMS 510(k) NO: K021352(SPECIAL)
ATTN: DAYNE GILLELAND PHONE NO : 937-461-5225
430 LEO ST. SE DECISION MADE: 01-AUG-02
DAYTON, OH 45404 510(k) STATEMENT
DEVICE: TAILWIND
DELTAGLIDE 510(k) NO: K022704(TRADITIONAL)
ATTN: JERE PERCHY PHONE NO : 203-230-0301
3 INDUSTRIAL CIRCLE SE DECISION MADE: 27-AUG-02
HAMDEN, CT 06517 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DELTEC INSULIN INFUSION PUMP AND ACCESSORIES
DELTEC, INC. 510(k) NO: K020655(TRADITIONAL)
ATTN: LISA STONE PHONE NO : 651-628-7224
1265 GREY FOX RD. SE DECISION MADE: 13-AUG-02
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRIPPER PLUS NEEDLE
DELTEC, INC. 510(k) NO: K021999(TRADITIONAL)
ATTN: LISA STONE PHONE NO : 651-628-7224
1265 GREY FOX RD. SE DECISION MADE: 13-AUG-02
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEAL & PROTECT PROTECTIVE SEALANT
DENTSPLY INTL. 510(k) NO: K021805(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE SE DECISION MADE: 19-AUG-02
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
DEPUY ACROMED 510(k) NO: K022246(SPECIAL)
ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704
325 PARAMOUNT DR. SE DECISION MADE: 02-AUG-02
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ISOLA SPINAL SYSTEM
DEPUY ACROMED 510(k) NO: K022285(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 13-AUG-02
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)
DEPUY ACROMED 510(k) NO: K022623(SPECIAL)
ATTN: FRANK MAAS PHONE NO : 508-828-3390
325 PARAMOUNT DR. SE DECISION MADE: 27-AUG-02
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPFIX EXTERNAL FIXATION SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K021933(TRADITIONAL)
ATTN: CHERYL K HASTINGS PHONE NO : 574-372-7006
700 ORTHOPAEDIC DR. SE DECISION MADE: 26-AUG-02
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
DIAGNOSTIC CHEMICALS, LTD. (USA) 510(k) NO: K022538(SPECIAL)
ATTN: MIKE BERG PHONE NO : 949-643-0406
26371 EVA STREET SE DECISION MADE: 23-AUG-02
LAGUNA HILLS, CA 92656 510(k) STATEMENT
DEVICE: IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K022603(SPECIAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 21-AUG-02
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLADDERSCAN BVI 6100
DIAGNOSTIC ULTRASOUND CORP. 510(k) NO: K022153(TRADITIONAL)
ATTN: RUSS GARRISON PHONE NO : 425-867-1348
21222 30TH DRIVE SE, STE. 120 SE DECISION MADE: 15-AUG-02
BOTHELL, WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FLASH-LITE LED DENTAL CURING LIGHT
DISCUS DENTAL, INC. 510(k) NO: K022184(TRADITIONAL)
ATTN: GARRY L HOLLAR PHONE NO : 310-845-8345
8550 HIGUERA STREET SE DECISION MADE: 20-AUG-02
CULVER CITY, CA 91761 510(k) STATEMENT
DEVICE: DISETRONIC D-TRON INSULIN INFUSION PUMP
DISETRONIC MEDICAL SYSTEMS AG 510(k) NO: K021725(SPECIAL)
ATTN: SANDRA SONIEC PHONE NO : 413 442 42884
KIRCHBERSTRASSE 190, POSTFACH SE DECISION MADE: 02-AUG-02
BURGDORF, SWITZERLAND CH-3401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILA
DORNIER MEDTECH AMERICA, INC. 510(k) NO: K021724(TRADITIONAL)
ATTN: TIM THOMAS PHONE NO : 770-514-6163
1155 ROBERTS BLVD. SE DECISION MADE: 19-AUG-02
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORNIER MEDILAS H LASER FIBER CABLES
DORNIER MEDTECH AMERICA, INC. 510(k) NO: K022544(SPECIAL)
ATTN: TIM THOMAS PHONE NO : 770-514-6163
1155 ROBERTS BLVD. SE DECISION MADE: 21-AUG-02
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
DRAEGER MEDICAL, INC. 510(k) NO: K022031(TRADITIONAL)
ATTN: MICHAEL A KELHART PHONE NO : 215-721-5400
3135 QUARRY RD. SE DECISION MADE: 29-AUG-02
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-CARE INFARED EAR THERMOMETER, MODEL LCT-200
E-CARE TECHNOLOGY CORPORATION 510(k) NO: K021753(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD SE DECISION MADE: 06-AUG-02
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: EBI DYNAFIX VS OSTEOTOMY SYSTEM
EBI, L.P. 510(k) NO: K021749(TRADITIONAL)
ATTN: JON CAPARETTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 12-AUG-02
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI XFIX DFS SYSTEM
EBI, L.P. 510(k) NO: K022319(SPECIAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 12-AUG-02
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
EBI, L.P. 510(k) NO: K022419(SPECIAL)
ATTN: JON CAPAROTTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 12-AUG-02
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS PIEZON MASTER 600
ELECTRO MEDICAL SYSTEMS SA 510(k) NO: K022328(SPECIAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 13-AUG-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMENIS SELECTA DUET
ELLEX MEDICAL PTY. LTD. 510(k) NO: K021550(TRADITIONAL)
ATTN: BILL SWAIM PHONE NO : 952-881-9100
7138 SHADY OAK ROAD SE DECISION MADE: 09-AUG-02
MINNEAPOLIS, MN 55344 510(k) STATEMENT
DEVICE: UNI KNEE
ENCORE MEDICAL, L.P. 510(k) NO: K022437(SPECIAL)
ATTN: JOANNA DROEGE PHONE NO : 512-834-6255
9800 METRIC BLVD. SE DECISION MADE: 23-AUG-02
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDIUS FLEXTIP BLADE
ENDIUS, INC. 510(k) NO: K022578(SPECIAL)
ATTN: CHRISTINE KUNTZ-NASSIF PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 23-AUG-02
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
ENTIFIC MEDICAL SYSTEMS, INC. 510(k) NO: K021837(TRADITIONAL)
ATTN: CONSTANCE BUNDY PHONE NO : 763-574-1976
6470 RIVERVIEW TERRACE SE DECISION MADE: 30-AUG-02
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEMENT RESTRICTOR, SMALL AND LARGE
EXACTECH, INC. 510(k) NO: K021765(TRADITIONAL)
ATTN: GARY MILLER PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 16-AUG-02
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 96 CHANNEL EEG HEADBOX MODEL EMU96
EXCEL TECH. LTD. 510(k) NO: K021599(TRADITIONAL)
ATTN: JOHN MUNFORD PHONE NO : 905 829 5300 351
2568 BRISTOL CIRCLE SE DECISION MADE: 13-AUG-02
OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERPESELECT 2 ELISA IGG, MODEL ELO920G
FOCUS TECHNOLOGIES, INC. 510(k) NO: K021486(TRADITIONAL)
ATTN: MICHAEL J WAGNER PHONE NO : 714-220-1900
10703 PROGRESS WAY SE DECISION MADE: 01-AUG-02
CYPRESS, CA 90630-4737 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFEPRO SAFETY SYRINGE
FORMOSA MEDICAL DEVICES, INC. 510(k) NO: K022063(TRADITIONAL)
ATTN: JOSEPH J CHANG PHONE NO : 972-365-8188
11497 COLUMBIA PARK DRIVE WEST SE DECISION MADE: 29-AUG-02
SUITE #9 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32258
DEVICE: FONIX, MODEL 7000
FRYE ELECTRONICS, INC. 510(k) NO: K022510(ABBREVIATED)
ATTN: KRISTINA FRYE PHONE NO : 503-620-2722
9826 S.W. TIGARD ST. SE DECISION MADE: 27-AUG-02
TIGARD, OR 97223 510(k) STATEMENT
DEVICE: PRISMA SYSTEM
GAMBRO RENAL PRODUCTS 510(k) NO: K010805(ABBREVIATED)
ATTN: SUZANNE DENNIS PHONE NO : 303-542-5075
10810 W. COLLINS AVE. SE DECISION MADE: 06-AUG-02
LAKEWOOD, CO 80215 510(k) STATEMENT
DEVICE: SIGNA 3.0T MAGNETIC RESONANCE SYSTEM
GE MEDICAL SYSTEMS 510(k) NO: K022397(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. 414 SE DECISION MADE: 22-AUG-02
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K022193(SPECIAL)
ATTN: MELISSA ROBINSON PHONE NO : 817-887-2133
4502 WOODLAND CORP.BLVD. SE DECISION MADE: 01-AUG-02
TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSA-CUFF, MODELS INFANT, CHILD, ADULT
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K022482(TRADITIONAL)
ATTN: MELISSA ROBINSON PHONE NO : 813-887-2133
4502 WOODLAND CORPORATE BLVD. SE DECISION MADE: 13-AUG-02
TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MOBILE MILLENNIUM MG SYSTEM
GE MEDICAL SYSTEMS, INC. 510(k) NO: K022240(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 06-AUG-02
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTAGE WINDOWS X-RAY/MR FUSION
GE MEDICAL SYSTEMS, INC. 510(k) NO: K022310(TRADITIONAL)
ATTN: LARRY KROGER PHONE NO : 414-544-3894
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 01-AUG-02
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DASH 3000/4000 PATIENT MONITOR
GENERAL ELECTRIC MEDICAL SYSTEMS I510(k) NO: K020290(TRADITIONAL)
ATTN: KAREN WEBB PHONE NO : 414-362-3329
8200 WEST TOWER AVE. SE DECISION MADE: 14-AUG-02
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAPH-LOOP LIGATING LOOP
GENZYME BIOSURGERY 510(k) NO: K022410(SPECIAL)
ATTN: KAREN K SYLVIA PHONE NO : 508-677-6448
600 AIRPORT RD. SE DECISION MADE: 20-AUG-02
FALL RIVER, MA 02720-4740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIVEN DIAGNOSTICS SYSTEM
GIVEN IMAGING LTD. 510(k) NO: K022362(SPECIAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 490 97784
NEW INDUSTRIAL PARK SE DECISION MADE: 09-AUG-02
P.O. BOX 258 510(k) SUMMARY AVAILABLE FROM FDA
YOQNEAM, ISRAEL 20692
DEVICE: GLOVCO EBONY
GLOVCO (M) SDN. BHD. 510(k) NO: K013828(TRADITIONAL)
ATTN: TAN PENG HOCK PHONE NO : 603 329 13888
LOT 760, JALAN HAJI SIRAT, SE DECISION MADE: 13-AUG-02
OFF JALAN MERU 510(k) STATEMENT
KLANG, SELANGOR D.E., MALAYSIA 42100
DEVICE: GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM
GRASS INSTRUMENT CO. 510(k) NO: K021807(TRADITIONAL)
ATTN: PETER L FULLER PHONE NO : 781-848-2970
570 LIBERTY ST. SE DECISION MADE: 29-AUG-02
BRAINTREE, MA 02185 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
GUIDANT CARDIAC SURGERY 510(k) NO: K022718(TRADITIONAL)
ATTN: ANNE SCHLAGENHAFT PHONE NO : 408-845-1842
3200 LAKESIDE DR. SE DECISION MADE: 28-AUG-02
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER
GUIDANT CORP. 510(k) NO: K021455(TRADITIONAL)
ATTN: KAREN S ALSOP PHONE NO : 651-582-3123
4100 HAMLINE AVE., NORTH SE DECISION MADE: 02-AUG-02
ST. PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY
GYRUS ENT L.L.C. 510(k) NO: K021777(TRADITIONAL)
ATTN: JEFFREY W COBB PHONE NO : 901-373-2673
2925 APPLING RD SE DECISION MADE: 26-AUG-02
BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARG
HANS RUDOLPH, INC. 510(k) NO: K020759(TRADITIONAL)
ATTN: KEVIN RUDOLPH PHONE NO : 816-363-5522
7205 CENTRAL SE DECISION MADE: 13-AUG-02
KANSAS CITY, MO 64114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001
HARMAC MEDICAL PRODUCTS, INC. 510(k) NO: K021916(TRADITIONAL)
ATTN: ROBERT F MORAN PHONE NO : 716-897-4500
2201 BAILEY AVE. SE DECISION MADE: 29-AUG-02
BUFFALO, NY 14211-1797 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIFE LIPPOROTEIN-12, MODEL 3344
HELENA LABORATORIES 510(k) NO: K022333(TRADITIONAL)
ATTN: PATRICIA FRANKS PHONE NO : 409-842-3714
1530 LINDBERGH DR. SE DECISION MADE: 15-AUG-02
PO BOX 752 510(k) STATEMENT
BEAUMONT, TX 77704
DEVICE: XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1
HELLEN PROFESSIONAL SERVICES 510(k) NO: K020226(TRADITIONAL)
ATTN: ROBIN HELLEN PHONE NO : 818-709-5646
9418 LASAINE AVENUE SE DECISION MADE: 22-AUG-02
NORTHRIDGE, CA 91325 510(k) STATEMENT
DEVICE: MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHIT
HEYUAN HONGLI INDUSTRIES, INC. 510(k) NO: K022305(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 08-AUG-02
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K021751(ABBREVIATED)
ATTN: DOUGLAS THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 15-AUG-02
TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HMS-DHR-3 NEUROMUSCULAR STIMULATOR
HOME MEDICAL SERVICES 510(k) NO: K021472(TRADITIONAL)
ATTN: C.A. TEKLINSKI PHONE NO : 858-621-5959
9393 ACTIVITY RD., SUITE F SE DECISION MADE: 06-AUG-02
SAN DIEGO, CA 92126 510(k) STATEMENT
DEVICE: HMS-DHR-3 NEUROMUSCULAR STIMULATOR
HOME MEDICAL SERVICES 510(k) NO: K021496(TRADITIONAL)
ATTN: C.A. TEKLINSKI PHONE NO : 858-621-5959
9393 ACTIVITY RD., SUITE F SE DECISION MADE: 06-AUG-02
SAN DIEGO, CA 92126 510(k) STATEMENT
DEVICE: HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES
HORIZONS INTL. CORP. 510(k) NO: K022546(TRADITIONAL)
ATTN: RAFIC SALEH PHONE NO : 787-842-4000
287 MONTERREY ST. SE DECISION MADE: 12-AUG-02
P.O.BOX 7273 510(k) STATEMENT
PONCE, PR 00717
DEVICE: XIA SPINAL SYSTEM
HOWMEDICA OSTEONICS 510(k) NO: K022160(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
59 ROUTE 17 SE DECISION MADE: 01-AUG-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S2 FEMORAL NAIL
HOWMEDICA OSTEONICS 510(k) NO: K022461(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
59 ROUTE 17 SE DECISION MADE: 22-AUG-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S2 TIBIAL NAIL
HOWMEDICA OSTEONICS CORP. 510(k) NO: K022481(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
59 ROUTE 17 SE DECISION MADE: 26-AUG-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCOLADE C FEMORAL STEMS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K022555(SPECIAL)
ATTN: DEBRA BING PHONE NO : 201-831-5413
59 ROUTE 17 SE DECISION MADE: 26-AUG-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULCRUM
HOWTEK, INC. 510(k) NO: K021949(TRADITIONAL)
ATTN: W. SCOTT PARR PHONE NO : 603-882-5200
21 PARK AVE. SE DECISION MADE: 12-AUG-02
HUDSON, NH 03051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR LES
HYCARE INTL. CO., LTD. 510(k) NO: K022530(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-9550
198 AVE. DE LA D'EMERALD SE DECISION MADE: 26-AUG-02
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPHERZ
I.Z.I. CORP. 510(k) NO: K022074(TRADITIONAL)
ATTN: HELEN ZINREICH PHONE NO : 410-594-9403
7020 TUDSBURY ROAD SE DECISION MADE: 13-AUG-02
BALTIMORE, MD 21244 510(k) STATEMENT
DEVICE: HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
IMPLEX CORP. 510(k) NO: K022563(SPECIAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 30-AUG-02
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROBOOT
INCAPPE, INC. 510(k) NO: K022233(TRADITIONAL)
ATTN: ROBERT SHERIDAN PHONE NO : 910-509-0403
632 DUNDEE DRIVE SE DECISION MADE: 12-AUG-02
WILMINGTON, NC 28405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INDUS TEXTILES TOWEL-STERILE AND NON-STERILE
INDUS TEXTILES, INC. 510(k) NO: K013958(TRADITIONAL)
ATTN: MICHELE H VOVOLKA PHONE NO : 847-856-0355
P.O. BOX 848 SE DECISION MADE: 19-AUG-02
GRAYSLAKE, IL 60030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR)
INNOVATIVE GLOVES CO; LTD 510(k) NO: K021668(TRADITIONAL)
ATTN: RAJEEV KUMAR SOOD PHONE NO : 667 447 4730
500 M004, T. KUANLUNG, HATYAI, SE DECISION MADE: 12-AUG-02
SONGKHLA, THAILAND 90110 510(k) STATEMENT
DEVICE: POLY-CARB
INOVATIV, LLC 510(k) NO: K022030(TRADITIONAL)
ATTN: ROBERT BOWERS PHONE NO : 503-585-4362
1155 TWIN HILLS DRIVE SE DECISION MADE: 28-AUG-02
JEFFERSON, OR 97352 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACETAL
INOVATIV, LLC 510(k) NO: K022032(TRADITIONAL)
ATTN: ROBERT BOWERS PHONE NO : 503-585-4362
1155 TWIN HILLS DRIVE SE DECISION MADE: 29-AUG-02
JEFFERSON, OR 97352 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COAMATIC AT-400
INSTRUMENTATION LABORATORY CO. 510(k) NO: K022195(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 07-AUG-02
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
INSTRUMENTATION LABORATORY CO. 510(k) NO: K022550(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 27-AUG-02
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BILAYER MATRIX WOUND DRESSING
INTEGRA LIFESCIENCES CORP. 510(k) NO: K021792(TRADITIONAL)
ATTN: DIANA M BORDON PHONE NO : 609-275-0500
311C ENTERPRISE DRIVE SE DECISION MADE: 14-AUG-02
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC
INTEGRA NEUROSCIENCES 510(k) NO: K022553(SPECIAL)
ATTN: NANCY A MATHEWSON PHONE NO : 858-622-2737
5955 PACIFIC CENTER BLVD. SE DECISION MADE: 20-AUG-02
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
INTEGRA NEUROSCIENCES 510(k) NO: K022554(SPECIAL)
ATTN: DONNA WALLACE PHONE NO : 609-936-2397
311 ENTERPRISE DRIVE SE DECISION MADE: 23-AUG-02
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE S
INTERPORE CROSS INTL. 510(k) NO: K022348(SPECIAL)
ATTN: PROSIE REY-FESSLER PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 15-AUG-02
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER
INTERVASCULAR 510(k) NO: K022242(TRADITIONAL)
ATTN: AMY AULWES PHONE NO : 781-431-7240
20 WALNUT ST. SE DECISION MADE: 14-AUG-02
SUITE 12 510(k) SUMMARY AVAILABLE FROM FDA
WELLESLEY, MA 02481
DEVICE: FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS
ISOLATION SYSTEMS, INC. 510(k) NO: K022260(TRADITIONAL)
ATTN: TED ULATOWSKI PHONE NO : 716-694-6390
79 FILLMORE AVE. SE DECISION MADE: 29-AUG-02
TONAWANDA, NY 14150-2335 510(k) STATEMENT
DEVICE: SR IVOCRON
IVOCLAR VIVADENT, INC. 510(k) NO: K013869(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 28-AUG-02
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: JENSEN GOLD FOIL
JENSEN INDUSTRIES, INC. 510(k) NO: K022206(TRADITIONAL)
ATTN: JOHN SLANSKI PHONE NO : 203-239-2090
50 STILLMAN RD. SE DECISION MADE: 29-AUG-02
NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-ASSAY HS-CRP CONTROLS
KAMIYA BIOMEDICAL CO. 510(k) NO: K022486(TRADITIONAL)
ATTN: BRIAN SCHLIESMAN PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 14-AUG-02
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: MODULITH SLK LITHOTRIPTER
KARL STORZ ENDOSCOPY 510(k) NO: K011700(TRADITIONAL)
ATTN: JENNIFER S PORTUGAL PHONE NO : 800-421-0837
600 CORPORATE POINTE SE DECISION MADE: 16-AUG-02
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA QUADRO SWITCH
KARL STORZ ENDOSCOPY 510(k) NO: K021776(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 15-AUG-02
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLO
LATEXX MANUFACTURING SDN.BHD. 510(k) NO: K022101(TRADITIONAL)
ATTN: LAW SIAU WOEI PHONE NO : 201-488-8086
216 CHARLES ST SE DECISION MADE: 02-AUG-02
HACKENSACK, NJ 07601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER E
LATEXX MANUFACTURING SDN.BHD. 510(k) NO: K022102(TRADITIONAL)
ATTN: LAW SIAU WOEI PHONE NO : 201-488-8086
216 CHARLES ST SE DECISION MADE: 22-AUG-02
HACKENSACK, NJ 07601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES
LATEXX MANUFACTURING SDN.BHD. 510(k) NO: K022347(TRADITIONAL)
ATTN: TEOH CHOH SHEE PHONE NO : 605 891 1111
PT. 5054, P.O. BOX 9 SE DECISION MADE: 15-AUG-02
KAMUNTING INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
TAIPING, PERAK, MALAYSIA 34600
DEVICE: MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVE
LATEXX MANUFACTURING SDN.BHD. 510(k) NO: K022548(TRADITIONAL)
ATTN: LAW SIAU WOEI PHONE NO : 201-488-8086
216 CHARLES ST SE DECISION MADE: 15-AUG-02
HACKENSACK, NJ 07601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WS-501 HEAT LAMP
LHASA MEDICAL, INC. 510(k) NO: K013197(TRADITIONAL)
ATTN: KYUNG P RIIHIMAKI PHONE NO : 781-340-1071
234 LIBBEY PKWY. SE DECISION MADE: 29-AUG-02
WEYMOUTH, MA 02189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
LIFESCAN, INC. 510(k) NO: K021819(TRADITIONAL)
ATTN: MARY ELLEN HOLDEN PHONE NO : 408-942-3589
1000 GIBRALTAR DR. SE DECISION MADE: 23-AUG-02
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR
LIGHTMED CORP. 510(k) NO: K021538(TRADITIONAL)
ATTN: IRENE LIN PHONE NO : 886 2 26764920
NO.1-1, LANE1,PAO-AN ST. SEC.3 SE DECISION MADE: 08-AUG-02
SHULIN CITY, CHINA (TAIWAN) 238 510(k) STATEMENT
DEVICE: CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K021887(TRADITIONAL)
ATTN: CHIU CHIN CHANG PHONE NO : 408-944-0360
2391 ZANKER RD., SUITE 340 SE DECISION MADE: 15-AUG-02
SAN JOSE, CA 95131-1124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LODOX, MODEL BASELINE
LODOX SYSTEMS (PTY) LTD. 510(k) NO: K013999(TRADITIONAL)
ATTN: BRADLEY SACKS PHONE NO : 212-439-0746
177 EAST 79TH STREET SE DECISION MADE: 06-AUG-02
SUITE 4 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10021
DEVICE: APL IGA ELISA KIT
LOUISVILLE APL DIAGNOSTICS, INC. 510(k) NO: K021398(TRADITIONAL)
ATTN: SILVIA S PIERANGELI PHONE NO : 770-455-7129
3988 FLOWERS RD., SUITE 620 SE DECISION MADE: 27-AUG-02
DORAVILLE, GA 30360 510(k) STATEMENT
DEVICE: CERANUM 87
LUCIUS METALS COM. 510(k) NO: K021947(TRADITIONAL)
ATTN: DAE-KYU CHANG PHONE NO : 562-799-6626
4241 FARQUHAR AVE. #2 SE DECISION MADE: 26-AUG-02
LOS ALAMITOS, CA 90720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERACAM
LUMALITE, INC. 510(k) NO: K021083(TRADITIONAL)
ATTN: W. EDWARD JOHANSEN PHONE NO : 310-826-4902
11661 SAN VICENTE BOULEVARD SE DECISION MADE: 30-AUG-02
LOS ANGELES, CA 90049 510(k) STATEMENT
DEVICE: BCLEAR
LUMENIS, INC. 510(k) NO: K021762(TRADITIONAL)
ATTN: C. ROBERT PAYNE, JR. PHONE NO : 925-249-8031
1249 QUARRY LN., SUITE 100 SE DECISION MADE: 23-AUG-02
PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAEDA SILVER ACUPUNCTURE NEEDLE
MAEDA TOYOKICHI SHOTEN 510(k) NO: K021904(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888-729-9674
P.O. BOX 4341 SE DECISION MADE: 14-AUG-02
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM
MAGLY ORTHOPEDICS, LLC 510(k) NO: K021579(TRADITIONAL)
ATTN: DAVE STINSON PHONE NO : 425-489-2057
15009 NE 195TH STREET SE DECISION MADE: 09-AUG-02
WOODINVILLE, WA 98072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGLY 6.5MM CANNULATED SCREWS
MAGLY ORTHOPEDICS, LLC 510(k) NO: K021662(TRADITIONAL)
ATTN: DAVE STINSON PHONE NO : 425-489-2057
14241 NE WOODINVILLE-DUVALL RD SE DECISION MADE: 12-AUG-02
#415 510(k) SUMMARY AVAILABLE FROM FDA
WOODINVILLE, WA 98072
DEVICE: STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENT
MAXXIM MEDICAL 510(k) NO: K021452(TRADITIONAL)
ATTN: JULIO GONZALEZ PHONE NO : 727-556-6152
4750 118TH AVE NORTH SE DECISION MADE: 01-AUG-02
CLEARWATER, FL 33762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MEDAMICUS AXIA RSN
MEDAMICUS, INC. 510(k) NO: K022689(SPECIAL)
ATTN: KARYL HASKELL PHONE NO : 763-559-2613
15301 HWY. 55 WEST SE DECISION MADE: 23-AUG-02
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55
MEDCOMP 510(k) NO: K021759(TRADITIONAL)
ATTN: FLORENCE A CAIKOSKI PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 27-AUG-02
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.5T SCANMED PV ARRAY
MEDIC, INC. 510(k) NO: K022395(SPECIAL)
ATTN: RANDALL W JONES PHONE NO : 402-571-3271
6912 NORTH 97TH CIRCLE, SE DECISION MADE: 13-AUG-02
SUITE C 510(k) SUMMARY AVAILABLE FROM FDA
OMAHA, NE 68122
DEVICE: PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWA
MEDICAL BIO CARE SWEDEN AB 510(k) NO: K022568(SPECIAL)
ATTN: CONNIE WHITE HOY PHONE NO : 530-666-7616
908 STETSON STREET SE DECISION MADE: 29-AUG-02
WOODLAND, CA 95776 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASC
MEDICAL BIO CARE SWEDEN AB 510(k) NO: K022569(SPECIAL)
ATTN: CONNIE WHITE HOY PHONE NO : 530-666-7616
908 STETSON STREET SE DECISION MADE: 29-AUG-02
WOODLAND, CA 95776 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIPLUS SINGLE USE GI MANOMETRY CATHETER
MEDIPLUS LTD. 510(k) NO: K013704(TRADITIONAL)
ATTN: ELIZABETH M PAUL PHONE NO : 727-535-1247
541 MORENO CIRCLE NE SE DECISION MADE: 05-AUG-02
ST. PETERSBURG, FL 33703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM
MEDRAD, INC. 510(k) NO: K021988(ABBREVIATED)
ATTN: LORRAINE R FREDES PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 29-AUG-02
INDIANOLA, PA 15051 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: VERTE-STACK SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K021791(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-344-1124
1800 PYRAMID PLACE SE DECISION MADE: 26-AUG-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TENOR SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K022191(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 28-AUG-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE
MEDTRONIC SURGICAL NAVIGATION TECH510(k) NO: K022414(SPECIAL)
ATTN: VICTORIA G RENDON PHONE NO : 720-890-3200
826 COAL CREEK CIR. SE DECISION MADE: 14-AUG-02
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION PLUS TUNA OFFICE SYSTEM; PRESISION TUNA OFFICE SYSTEM;
MEDTRONIC, INC. 510(k) NO: K021804(TRADITIONAL)
ATTN: JULIE GOODE PHONE NO : 763-514-7247
800 53RD AVE NE SE DECISION MADE: 28-AUG-02
MINNEAPOLIS, MN 55421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGO
MEDTRONIC, INC. 510(k) NO: K021902(TRADITIONAL)
ATTN: LUCY TAN PHONE NO : 763-391-9000
7611 NORTHLAND DRIVE SE DECISION MADE: 12-AUG-02
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 7F LAUNCHER GUIDE CATHETER
MEDTRONIC, INC. 510(k) NO: K022764(SPECIAL)
ATTN: FRED L BOUCHER PHONE NO : 978-777-0042
37A CHERRY HILL DR. SE DECISION MADE: 28-AUG-02
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENVOY
MENNEN MEDICAL LTD. 510(k) NO: K022168(SPECIAL)
ATTN: DAVID P JOHNSON PHONE NO : 716-759-6921
10123 MAIN STREET SE DECISION MADE: 01-AUG-02
CLARENCE, NY 14031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR
MEPS, LLC. 510(k) NO: K020400(TRADITIONAL)
ATTN: HARRY BENEDICT PHONE NO : 954-713-8017
ONE EAST BROWARD BLVD #700 SE DECISION MADE: 23-AUG-02
FORT LAUDERDALE, FL 33301 510(k) STATEMENT
DEVICE: ABR-2000
MERIDIAN CO., LTD. 510(k) NO: K020360(TRADITIONAL)
ATTN: SOO-RANG LEE PHONE NO : 822 210 33320
9FI SEOIL BLDG SE DECISION MADE: 29-AUG-02
222 JAMSILBON-DONG 510(k) SUMMARY AVAILABLE FROM FDA
SONGPA-GU, SEOUL, REPUBLIC OF KOREA
DEVICE: EASYTEM EAR THERMOMETER, MODEL BT-020
METATECH CO., LTD. 510(k) NO: K020520(TRADITIONAL)
ATTN: GUENTER GINSBERG PHONE NO : 941-948-2001
11820 RED HIBISCUS DRIVE SE DECISION MADE: 06-AUG-02
BONITA SPRINGS, FL 34135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MHS MED LIGHT 1000
MICRO HEALTH SYSTEMS INC. 510(k) NO: K021956(TRADITIONAL)
ATTN: ROBERT BARNES PHONE NO : 954-575-1076
7407 DOVER LANE SE DECISION MADE: 13-AUG-02
PARKLAND, FL 33067 510(k) STATEMENT
DEVICE: MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT
MILTON HODOSH, M.D. 510(k) NO: K022025(TRADITIONAL)
ATTN: MILTON HODOSH PHONE NO : 401-781-3591
243 ELWOOD AVENUE SE DECISION MADE: 15-AUG-02
PROVIDENCE, RI 02907 510(k) STATEMENT
DEVICE: MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL
MINIMED, INC. 510(k) NO: K021974(TRADITIONAL)
ATTN: GERDA RESCH PHONE NO : 818-576-4198
18000 DEVONSHIRE ST. SE DECISION MADE: 06-AUG-02
NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUTURE FIXATION DEVICE; MESH FIXATION DEVICE
MLE, INC. 510(k) NO: K021834(TRADITIONAL)
ATTN: CHRISTINE E NICHOLS PHONE NO : 508-839-6122
10 GREENLAWN AVE SE DECISION MADE: 28-AUG-02
S. GRAFTON, MA 01560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MPW HEMODIALYSIS WATER PURIFICATION SYSTEM
MPW INDUSTRIAL WATER SERVICES, INC510(k) NO: K001755(ABBREVIATED)
ATTN: BILL WATSON PHONE NO : 330-273-8494
2848 INTERSTATE PARKWAY SE DECISION MADE: 05-AUG-02
BRUNSWICK, OH 44212 510(k) STATEMENT
DEVICE: ISA-21 INTERVENTIONAL SPINE ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K021631(TRADITIONAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SUITE A SE DECISION MADE: 13-AUG-02
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: HRH-127-8 HEAD ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K022372(SPECIAL)
ATTN: TOM SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 13-AUG-02
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K022487(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 23-AUG-02
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: MODEL OBC-63 BREAST ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K022488(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 23-AUG-02
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: NANMA ADJUSTABLE CONSTRICTION RING
NANMA MFG CO., LTD. 510(k) NO: K013051(TRADITIONAL)
ATTN: YOLANDA SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 22-AUG-02
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: CERALOY
NEIRYNCK & VOGT NV 510(k) NO: K021971(TRADITIONAL)
ATTN: JOSH ANDRACHEK PHONE NO : 614-577-1945
12960 STONECREEK DRIVE SE DECISION MADE: 01-AUG-02
PICKERINGTON, OH 43147 510(k) STATEMENT
DEVICE: 800 SERIES EASYNEB NEBULIZER
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K020357(TRADITIONAL)
ATTN: GINA TO PHONE NO : 925-463-4427
4280 HACIENDA DR. SE DECISION MADE: 07-AUG-02
PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HALLU PLATES
NEWDEAL S.A. 510(k) NO: K021626(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 12-AUG-02
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAINET
NICOLET BIOMEDICAL, INC. 510(k) NO: K021986(TRADITIONAL)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 23-AUG-02
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPERMASSIST
NIDACON INTERNATIONAL AB 510(k) NO: K022443(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 28-AUG-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXLINE CLAMP
NOVARE SURGICAL SYSTEMS, INC. 510(k) NO: K010727(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-3640
200 GREGORY LANE SE DECISION MADE: 09-AUG-02
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389
DEVICE: RF TENT
ODIN MEDICAL TECHNOLOGIES LTD. 510(k) NO: K022157(TRADITIONAL)
ATTN: ADI ICKOWICZ PHONE NO : 972 495 91010
P.O. BOX 548 SE DECISION MADE: 28-AUG-02
YOKNEAM ELIT, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MSS-28CS-301/701 NEEDLESCOPE
OLYMPUS OPTICAL CO., LTD. 510(k) NO: K013759(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 20-AUG-02
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
OLYMPUS OPTICAL CO., LTD. 510(k) NO: K022270(SPECIAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 14-AUG-02
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25
OPHTHALMED LLC 510(k) NO: K021696(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
1308 MORNINGSIDE PARK DRIVE SE DECISION MADE: 20-AUG-02
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUSDUO EC DENTAL LASER SYSTEM
OPUSDENT LTD. 510(k) NO: K021508(TRADITIONAL)
ATTN: DORIT WINITZ PHONE NO : 972 9 7718130
117 AHUZAH ST. SE DECISION MADE: 07-AUG-02
RA'ANANNA, ISRAEL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOBAG, MODEL CB
ORIGEN BIOMEDICAL, INC. 510(k) NO: K021702(TRADITIONAL)
ATTN: RICHARD MARTIN PHONE NO : 512-474-7278
9709-A BECK CIRCLE SE DECISION MADE: 06-AUG-02
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO AVALON CUP SYSTEM
ORTHOPEDIC SOURCE INC. 510(k) NO: K022711(SPECIAL)
ATTN: STEVEN M MANDELL PHONE NO : 800-500-0381
5975 HORSESHOE BAR ROAD SE DECISION MADE: 26-AUG-02
P.O. BOX 307 510(k) SUMMARY AVAILABLE FROM FDA
LOOMIS, CA 95650
DEVICE: NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120
ORTHOSOFT, INC. 510(k) NO: K021760(TRADITIONAL)
ATTN: CHRISTOPHER MCLEAN PHONE NO : 514 861 4074
75 QUEEN ST., SUITE 3300 SE DECISION MADE: 27-AUG-02
MONTREAL, QUEBEC, CANADA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3A DENTAL IMPLANT SYSTEM
OSSECO BIOSOURCE, LTD 510(k) NO: K011879(TRADITIONAL)
ATTN: MICHELE H VOVOLKA PHONE NO : 847-856-0355
P.O.BOX 848 SE DECISION MADE: 27-AUG-02
GRAYSLAKE, IL 60030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRAORAL MANDIBULAR DISTRACTION SYSTEM
OSTEOMED CORP. 510(k) NO: K013618(TRADITIONAL)
ATTN: DAWN T HOLDEMAN PHONE NO : 972-241-3401
3750 REALTY RD. SE DECISION MADE: 14-AUG-02
ADDISON, TX 75001-4311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSA RIGID INTERNAL FIXATION SYSTEM
OSTEOMED CORP. 510(k) NO: K021618(TRADITIONAL)
ATTN: DAWN T HOLDEMAN PHONE NO : 972-241-3401
3750 REALTY RD. SE DECISION MADE: 08-AUG-02
ADDISON, TX 75001-4311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORMED BONE TRANSPORT DISTRACTION DEVICE
OSTEOMEDICS, INC. 510(k) NO: K021341(TRADITIONAL)
ATTN: ALBERT ENAYATI PHONE NO : 201-444-7306
809 CARTER LANE SE DECISION MADE: 01-AUG-02
PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR
OSTEOMEDICS, INC. 510(k) NO: K021342(TRADITIONAL)
ATTN: ALBERT ENAYATI PHONE NO : 201-444-7306
809 CARTER LANE SE DECISION MADE: 01-AUG-02
PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAI
P.T. HEALTHCARE GLOVINDO 510(k) NO: K021659(TRADITIONAL)
ATTN: ELLEN HUTAPEA PHONE NO : 626 168 50017
JL. KOL. YOS SUDARSO K.M. 10 SE DECISION MADE: 12-AUG-02
KAWASAN INDUSRI MEDAN 510(k) STATEMENT
MEDAN, INDONESIA 10340
DEVICE: PALL ULTIPOR ANESTHESIA BREATHING SYSTEM
PALL MEDICAL 510(k) NO: K013093(TRADITIONAL)
ATTN: LEONARD S BERMAN PHONE NO : 516-484-5400
600 S. WAGNER RD. SE DECISION MADE: 01-AUG-02
ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIBAND
PAW, LLC 510(k) NO: K022404(TRADITIONAL)
ATTN: ANDREW J WHELAN PHONE NO : 301-682-4795
5540 HIDDEN WATERS LANE SE DECISION MADE: 08-AUG-02
FREDERICK, MD 21703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIONOMER
PENTRON CLINICAL TECHNOLOGIES 510(k) NO: K022150(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 21-AUG-02
WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL
PENTRON CORP. 510(k) NO: K021457(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD SE DECISION MADE: 01-AUG-02
P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492
DEVICE: CHITO-SEAL
PERCLOSE, INC. 510(k) NO: K021062(TRADITIONAL)
ATTN: SEVRINA CIUCCI PHONE NO : 650-474-3164
400 SAGINAW DRIVE SE DECISION MADE: 23-AUG-02
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT
PERSONAL PRODUCTS CO., DIV. OF MCN510(k) NO: K021492(TRADITIONAL)
ATTN: MARYLOU PANICO PHONE NO : 908-904-3709
199 GRANDVIEW RD. SE DECISION MADE: 07-AUG-02
SKILLMAN, NJ 08558-9418 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE V
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K022601(TRADITIONAL)
ATTN: JAMES F LOGAN PHONE NO : 410-837-1751
1301 DEFENCE HIGHWAY SE DECISION MADE: 26-AUG-02
GAMBRILLS, MD 21054 510(k) STATEMENT
DEVICE: PHILIPS BABY THERMOMETER SET (SBC SC530)
PHILIPS CONSUMER ELECTRONICS 510(k) NO: K022542(TRADITIONAL)
ATTN: BOB POOLER PHONE NO : 865-521-4701
ONE PHILIPS DRIVE SE DECISION MADE: 20-AUG-02
KNOXVILLE, TN 37914 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERF (OMMAYA STYLE) RESERVOIRS
PHOENIX BIOMEDICAL CORP. 510(k) NO: K021644(TRADITIONAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMISTEAD AVE. SE DECISION MADE: 06-AUG-02
P.O. BOX 80390 510(k) STATEMENT
VALLEY FORGE, PA 19484
DEVICE: PTS PANELS MULTI-CHEMISTRY CONTROLS
POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K022401(TRADITIONAL)
ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610
7736 ZIONSVILLE RD. SE DECISION MADE: 21-AUG-02
INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010
POLYSTAN A/S 510(k) NO: K013038(TRADITIONAL)
ATTN: DANA OLSEN PHONE NO : 454 465 1566
WALGERHOLM 8 SE DECISION MADE: 14-AUG-02
VAERLOSE, DENMARK DK-3500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
POLYSTAN A/S 510(k) NO: K022281(TRADITIONAL)
ATTN: DANA OLSEN PHONE NO : 45 44 651566
WALGERHOLM 8 SE DECISION MADE: 06-AUG-02
VAERLOSE, DENMARK DK-3500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
POREX SURGICAL, INC. 510(k) NO: K021357(TRADITIONAL)
ATTN: HOWARD MERCER PHONE NO : 678-479-1610
15 DART RD. SE DECISION MADE: 05-AUG-02
NEWNAN, GA 30265 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM
PRAXIM 510(k) NO: K022239(TRADITIONAL)
ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 23-AUG-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS
PRECISION SYSTEMS, INC. 510(k) NO: K022072(TRADITIONAL)
ATTN: BILL HADEN PHONE NO : 508-655-7010
16 TECH CIRCLE SE DECISION MADE: 23-AUG-02
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM
PT. MAJA AGUNG LATEXINDO 510(k) NO: K020040(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 909-591-8855
5445 DANIEL STREET SE DECISION MADE: 01-AUG-02
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION P
PURITAN-BENNETT 510(k) NO: K021573(SPECIAL)
ATTN: GINA TO PHONE NO : 925-463-4427
2200 FARADAY AVENUE SE DECISION MADE: 13-AUG-02
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY
QUALIGEN, INC. 510(k) NO: K021972(TRADITIONAL)
ATTN: DOROTHY DEINZER PHONE NO : 760-918-9165
2042 CORTE DEL NOGAL SE DECISION MADE: 21-AUG-02
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE
QUANTEL MEDICAL 510(k) NO: K021650(TRADITIONAL)
ATTN: ROGER W BARNES PHONE NO : 501-525-8612
342 SUNSET BAY ROAD SE DECISION MADE: 16-AUG-02
HOT SPRINGS, AR 71913 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX LIPID CONTROL
RANDOX LABORATORIES, LTD. 510(k) NO: K022591(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 440 289 4422413
ARDMORE, DIAMOND ROAD SE DECISION MADE: 30-AUG-02
CRUMLIN, CO. ANTRIM, UNITED KINGDO510(k) STATEMENT
DEVICE: MULTI FUCTIONAL REHABILITATION CHAIR
RAYE'S, INC. 510(k) NO: K022407(TRADITIONAL)
ATTN: WILLARD LEE FRICKEY PHONE NO : 800-537-6454
204 WEST 2ND ST. SE DECISION MADE: 16-AUG-02
ELLIS, KS 67637 510(k) STATEMENT
DEVICE: DISPO MULTI (METHAFILCON A) SOFT (HYDROPILIC) MULTIFOCAL LENS FO
REGULATORY INSIGHT, INC. 510(k) NO: K021720(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LN. SE DECISION MADE: 12-AUG-02
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-
REHABILICARE, INC. 510(k) NO: K022405(SPECIAL)
ATTN: EDWARD F VALDEZ PHONE NO : 651-638-0448
1811 OLD HIGHWAY 8 SE DECISION MADE: 12-AUG-02
NEW BRIGHTON, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOPULSE RESUSCITATION SYSTEM
REVIVANT CORP. 510(k) NO: K022345(SPECIAL)
ATTN: SUSANNE T SMITH PHONE NO : 408-524-3500
775 PALOMAR AVE. SE DECISION MADE: 15-AUG-02
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHIGENE MESACUP-2 TEST RNP, MODEL M7741
RHIGENE, INC. 510(k) NO: K022017(TRADITIONAL)
ATTN: YUSUKE KOBE PHONE NO : 847-375-9091
455 STATE ST., SE DECISION MADE: 14-AUG-02
SUITE 104 510(k) STATEMENT
DES PLAINES, IL 60068
DEVICE: ELECSYS ANTI-TG TEST SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K020672(TRADITIONAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 05-AUG-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
ROCHE DIAGNOSTICS CORP. 510(k) NO: K022654(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 29-AUG-02
PO BX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q4
ROSSMAX INTERNATIONL LTD. 510(k) NO: K020897(ABBREVIATED)
ATTN: MICHAEL YEH PHONE NO : 011 886 226597888
12F, NO. 189, KANG CHIEN RD. SE DECISION MADE: 06-AUG-02
TAIPEI, CHINA (TAIWAN) 114 510(k) STATEMENT
DEVICE: RUSCH EDGAR TUBE
RUSCH INTL. 510(k) NO: K021540(TRADITIONAL)
ATTN: RICK LYKINS PHONE NO : 603-532-0204
TALL PINES PARK SE DECISION MADE: 01-AUG-02
JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTIM 16 AUTOCLAVE
SCICAN 510(k) NO: K021064(TRADITIONAL)
ATTN: BRENDA MURPHY PHONE NO : 416 446 2797
1440 DON MILLS RD. SE DECISION MADE: 08-AUG-02
TORONTO, ONTARIO, CANADA M3B 3P9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE S
SENORX, INC. 510(k) NO: K021707(TRADITIONAL)
ATTN: AMY BOUCLY PHONE NO : 949-362-4800
11 COLUMBIA, SUITE A SE DECISION MADE: 14-AUG-02
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERRALGUT
SERRAL, S.A. DE C.V. 510(k) NO: K020597(TRADITIONAL)
ATTN: SCOTT HENDERSON PHONE NO : 727-773-0414
2584 SADDLEWOOD LANE SE DECISION MADE: 14-AUG-02
PALM HARBOR,, FL 34685 510(k) STATEMENT
DEVICE: DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR, POWDER FREE W
SHANGHAI ANTARES INDUSTRIES, INC. 510(k) NO: K021853(TRADITIONAL)
ATTN: JOHN LAI PHONE NO : 011 862 157814213
259 YUSHU RD., SE DECISION MADE: 01-AUG-02
CANGQIAO TOWNSHIP 510(k) STATEMENT
SONGJIANG SHANGHAI, CHINA 201600
DEVICE: 3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K022337(SPECIAL)
ATTN: AMY SHAW HOSLER PHONE NO : 732-321-4830
186 WOOD AVENUE SOUTH SE DECISION MADE: 13-AUG-02
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANA
SIGMA DIAGNOSTICS, INC. 510(k) NO: K021162(TRADITIONAL)
ATTN: WILLIAM R GILBERT II PHONE NO : 314-286-6693
545 SOUTH EWING AVE. SE DECISION MADE: 30-AUG-02
ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X
SINTEA BIOTECH, INC. 510(k) NO: K022065(TRADITIONAL)
ATTN: MARIANNE GRUNWALDT PHONE NO : 305-673-6226
407 LINCOLN RD. SUITE 10L SE DECISION MADE: 06-AUG-02
MIAMI BEACH, FL 33139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTAL KNEE FEMORAL COMPONENT
SMITH & NEPHEW, INC. 510(k) NO: K022010(SPECIAL)
ATTN: KIM KELLY PHONE NO : 800-821-5700
1450 E. BROOKS ROAD SE DECISION MADE: 19-AUG-02
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATION
SMITH & NEPHEW, INC. 510(k) NO: K022460(SPECIAL)
ATTN: GINO ROUSS PHONE NO : 901-399-6707
1450 E. BROOKS ROAD SE DECISION MADE: 19-AUG-02
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFLECTION MODIFIED ACETABULAR SHELLS
SMITH & NEPHEW, INC. 510(k) NO: K022556(SPECIAL)
ATTN: KIM KELLY PHONE NO : 901-396-2121
1450 E. BROOKS ROAD SE DECISION MADE: 28-AUG-02
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-REL
SOOIL DEVELOPMENT CO., LTD. 510(k) NO: K022317(SPECIAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 02-AUG-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COSMOS SYSTEM
SPACELABS MEDICAL, INC. 510(k) NO: K013046(TRADITIONAL)
ATTN: EDWARD M BASILE PHONE NO : 202-626-2903
1730 PENNSYLVANIA AVE. NW SE DECISION MADE: 21-AUG-02
WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESCAPE CONTROL MODULE
SPECIALTY DRIVES TECHNOLOGIES, INC510(k) NO: K021995(TRADITIONAL)
ATTN: SCOTT KERSEY PHONE NO : 770-363-7398
509 PLEASANT HILL CHURCH RD. SE DECISION MADE: 01-AUG-02
WINDER, GA 30680 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTITUDE CEMENT RESTRICTOR
SPINAL CONCEPTS, INC. 510(k) NO: K021719(TRADITIONAL)
ATTN: DAVID M HOOPER PHONE NO : 512-918-2700
12012 TECHNOLOGY BLVD., #100 SE DECISION MADE: 15-AUG-02
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADENCE CEMENT RESTRICTOR
SPINAL CONCEPTS, INC. 510(k) NO: K022218(TRADITIONAL)
ATTN: DAVID M HOOPER PHONE NO : 512-918-2700
12012 TECHNOLOGY BLVD., #100 SE DECISION MADE: 12-AUG-02
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLUS PIVOT LINK UNIVERSAL SYSTEM
SPINE VISION, INC 510(k) NO: K021507(TRADITIONAL)
ATTN: LYNNETTE WHITAKER PHONE NO : 574-269-9776
3003 SUMMIT BLVD SE DECISION MADE: 01-AUG-02
15TH FLOOR SUITE 1500 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30319
DEVICE: UNI-T UNI-THREAD SPINAL SYSTEM
SPINE VISION, INC 510(k) NO: K021510(TRADITIONAL)
ATTN: LYNNETTE WHITAKER PHONE NO : 404-460-5075
3003 SUMMIT BLVD SE DECISION MADE: 01-AUG-02
15TH FLOOR SUITE 1500 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30319
DEVICE: CONTOURED ATCULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYST
STD MFG., INC. 510(k) NO: K021549(TRADITIONAL)
ATTN: STEVE EK PHONE NO : 781-828-4400
1063 TURNPIKE ST. SE DECISION MADE: 01-AUG-02
P.O. BOX 420 510(k) SUMMARY AVAILABLE FROM FDA
STOUGHTON, MA 02072
DEVICE: REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
STERILMED, INC. 510(k) NO: K012523(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 14-AUG-02
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
STERILMED, INC. 510(k) NO: K012678(TRADITIONAL)
ATTN: PATICK FLEISCHHACKER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 14-AUG-02
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER L3 HYDROLERT
STRYKER ENDOSCOPY 510(k) NO: K022248(TRADITIONAL)
ATTN: MICHAEL HILLDOERFER PHONE NO : 408-754-2664
5900 OPTICAL CT. SE DECISION MADE: 06-AUG-02
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONESOURCE HAC
STRYKER INSTRUMENTS 510(k) NO: K021440(TRADITIONAL)
ATTN: WADE T RUTKOSKIE PHONE NO : 616-323-4226
4100 EAST MILHAM AVENUE SE DECISION MADE: 02-AUG-02
KALAMAZOO, MI 49087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYK
STRYKER INSTRUMENTS 510(k) NO: K022162(SPECIAL)
ATTN: DANNIELLE WHEELER PHONE NO : 616-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 01-AUG-02
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIOSYSTEM/NT, MODEL 80-13020
STYKER INSTRUMENTS 510(k) NO: K020320(TRADITIONAL)
ATTN: KELLI BITTERBURG PHONE NO : 877-534-2464
4100 EAST MILHAM AVE. SE DECISION MADE: 28-AUG-02
KALAMAZOO, MI 49001 510(k) STATEMENT
DEVICE: NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE
SULZER ORTHOPEDICS, INC. 510(k) NO: K021578(TRADITIONAL)
ATTN: FRANCES E HARRISON PHONE NO : 512-432-9306
9900 SPECTRUM DR. SE DECISION MADE: 09-AUG-02
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY
SUNI IMAGING MICROSYSTEMS, INC. 510(k) NO: K021718(TRADITIONAL)
ATTN: F. AL BETTENCOURT PHONE NO : 408-227-6698
6840 VIA DEL ORO, SUITE 10 SE DECISION MADE: 15-AUG-02
SAN JOSE, CA 95119 510(k) STATEMENT
DEVICE: DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR
SURGICON, INC. 510(k) NO: K021747(TRADITIONAL)
ATTN: CURTIS RAYMOND PHONE NO : 203-380-8771
400 LONG BEACH BLVD. SE DECISION MADE: 15-AUG-02
STRATFORD, CT 06615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM
SYMMETRY MEDICAL, INC. 510(k) NO: K012105(TRADITIONAL)
ATTN: D. DARIN MARTIN PHONE NO : 219-268-2252
220 WEST MARKET SE DECISION MADE: 02-AUG-02
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE
SYNERGETICS, INC. 510(k) NO: K020220(TRADITIONAL)
ATTN: SUE OSTER PHONE NO : 636-939-5100
88 HUBBLE DR. SE DECISION MADE: 23-AUG-02
ST. CHARLES, MO 63304-8694 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
SYNTHES (USA) 510(k) NO: K021556(TRADITIONAL)
ATTN: BONNIE J SMITH PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 09-AUG-02
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: SYNTHES CRANIOFACIAL PLATES
SYNTHES (USA) 510(k) NO: K021642(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 14-AUG-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADAPT OPEN ACCESS PORT, MODEL 41233
TAUT, INC. 510(k) NO: K021731(TRADITIONAL)
ATTN: MAX CLOAT PHONE NO : 630-232-2507
2571 KANEVILLE COURT SE DECISION MADE: 08-AUG-02
GENEVA, IL 60134 510(k) STATEMENT
DEVICE: TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM
TENSYS MEDICAL, INC. 510(k) NO: K020537(TRADITIONAL)
ATTN: STUART L GALLANT PHONE NO : 858-552-1941
5825 OBERLIN DRIVE SE DECISION MADE: 15-AUG-02
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: MININEPH HUMAN B2-MICROGLOBULIN KIT
THE BINDING SITE, LTD. 510(k) NO: K014270(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 15-AUG-02
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY
THE ELECTRIC STORE 510(k) NO: K022197(TRADITIONAL)
ATTN: CARL YOUNGMANN PHONE NO : 206-720-1540
936-11TH AVENUE EAST SE DECISION MADE: 13-AUG-02
SEATTLE, WA 98102 510(k) STATEMENT
DEVICE: MODIFICATION TO RELIEF BRIEF
THE JM KOHN CO. 510(k) NO: K003128(TRADITIONAL)
ATTN: CHARLES L MORIN PHONE NO : 415-957-0101
201 SPEAR STREET SE DECISION MADE: 12-AUG-02
SUITE 1600 510(k) SUMMARY AVAILABLE FROM FDA
SAN FRANCISCO, CA 94105-1635
DEVICE: TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES
TOP GLOVE MEDICAL (THAILAND) CO., 510(k) NO: K021950(TRADITIONAL)
ATTN: AUDIE SEOW PHONE NO : 66 74 412913
NO 58 MOO 7 KARNCHANAWANICH RD SE DECISION MADE: 01-AUG-02
PRIK, SADAO 510(k) STATEMENT
SONGKHLA, THAILAND 90120
DEVICE: TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELL
TOP GLOVE SDN. BHD. 510(k) NO: K021855(TRADITIONAL)
ATTN: LIM WEE CHAI PHONE NO : 603 339 21992
LOT 4968 JALAN TERATAI, BATU 6 SE DECISION MADE: 05-AUG-02
OFF JALAN MERU, 41050 KLANG 510(k) STATEMENT
SELANGOR, D.E., MALAYSIA
DEVICE: SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K022400(TRADITIONAL)
ATTN: MICHAELA MAHL PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 06-AUG-02
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: FLAT PANEL DISPLAYS, ME SERIES & CCL SERIES
TOTOKU ELECTRIC CO., LTD 510(k) NO: K021738(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 011 812 68345484
300 OYA, UEDA-SHI, SE DECISION MADE: 19-AUG-02
NAGANO-KEN, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSONIC FLOW-QC SET MODEL ADT1010
TRANSONIC SYSTEMS, INC. 510(k) NO: K021571(TRADITIONAL)
ATTN: MARK S ALSBERGE PHONE NO : 607-257-5300
34 DUTCH MILL RD. SE DECISION MADE: 12-AUG-02
ITHACA, NY 14850-9787 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAGUIDE CTG 2000SA
ULTRAGUIDE LTD. 510(k) NO: K022354(SPECIAL)
ATTN: GEORGE MYERS PHONE NO :
377 ROUTE 17 SOUTH SE DECISION MADE: 13-AUG-02
HASBROUCK HEIGHTS, NJ 07601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYTOFLEX MESH
UNICARE BIOMEDICAL, INC. 510(k) NO: K021511(TRADITIONAL)
ATTN: STAN YANG PHONE NO : 949-643-6707
25951 LA CUESTA AVE. SE DECISION MADE: 06-AUG-02
LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UKNEE TOTAL KNEE SYSTEM
UNITED ORTHOPEDIC CORP. 510(k) NO: K021657(TRADITIONAL)
ATTN: PHILIP LEUNG PHONE NO : 886 356 63351
57 PARK AVE. 2, SCIENCE PARK SE DECISION MADE: 12-AUG-02
HSINCHU, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K012687(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 863-327-8680
5307 GREAT OAK DR. SE DECISION MADE: 01-AUG-02
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURE-LOK
VITAL SIGNS, INC. 510(k) NO: K021315(ABBREVIATED)
ATTN: THOMAS W DIELMANN PHONE NO : 303-790-4835
11039 EAST LANSING CIRCLE SE DECISION MADE: 21-AUG-02
ENGLEWOOD, CO 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE PRESSURE MANOMETER
VITAL SIGNS, INC. 510(k) NO: K022402(TRADITIONAL)
ATTN: DAVID L NAJJAR PHONE NO : 973-790-1330
20 CAMPUS ROAD SE DECISION MADE: 22-AUG-02
TOTOWA, NJ 07512 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCLIP
VMBC, LLC 510(k) NO: K021745(TRADITIONAL)
ATTN: DAVID ELLIOT, JR. PHONE NO : 651-482-8451
3600 LABORE ROAD SE DECISION MADE: 20-AUG-02
SUITE 4 510(k) SUMMARY AVAILABLE FROM FDA
WHITE BEAR LAKE, MN 55110
DEVICE: REGISTRADO X-TRA
VOCO GMBH 510(k) NO: K022066(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 14-AUG-02
BEND, OR 97702 510(k) STATEMENT
DEVICE: LASER FIBER GF500
W.O.M. WORLD OF MEDICINE AG 510(k) NO: K021686(TRADITIONAL)
ATTN: SUSANNE RAAB PHONE NO : 617-868-3995
91 TROWBRIDGE STREET SE DECISION MADE: 20-AUG-02
CAMBRIDGE, MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER
WECK 510(k) NO: K021808(TRADITIONAL)
ATTN: JAMES LUCKY PHONE NO : 919-361-1401
2917 WECK DR. SE DECISION MADE: 14-AUG-02
DURHAM, NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM
WELCH ALLYN PROTOCOL, INC. 510(k) NO: K022453(SPECIAL)
ATTN: DON M ABBEY PHONE NO : 503-530-7500
8500 S.W. CREEKSIDE PLACE SE DECISION MADE: 21-AUG-02
BEAVERTON, OR 97008-7107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURACLEAN WITH LYCRA POWDER FREE POLYURETHANE MEDICAL EXAMINATIO
WILSHIRE TECHNOLOGIES 510(k) NO: K022095(TRADITIONAL)
ATTN: STEVE REITZLER PHONE NO : 619-977-1465
13221 MARICOTTE PLACE SE DECISION MADE: 09-AUG-02
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ER150/M2
WORLD OF MEDICINE LEMKE GMBH 510(k) NO: K021456(TRADITIONAL)
ATTN: SUSANNE RAAB PHONE NO : 617-868-3995
91 TROWBRIDGE STREET SE DECISION MADE: 01-AUG-02
CAMBRIDGE, MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5
WORLD OF MEDICINE LEMKE GMBH 510(k) NO: K021717(TRADITIONAL)
ATTN: SUSANNE RAAB PHONE NO : 617-868-3995
91 TROWBRIDGE STREET SE DECISION MADE: 20-AUG-02
CAMBRIDGE, MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DB1 EMBRYO FREEZE
ZANDER MEDICAL SUPPLIES, INC. 510(k) NO: K011327(TRADITIONAL)
ATTN: FRED ZANDER PHONE NO : 561-569-5955
755 8TH CT., SUITE #4 SE DECISION MADE: 15-AUG-02
P.O.650790 510(k) SUMMARY AVAILABLE FROM FDA
VERO BEACH, FL 32962
TOTAL 510(k)s THIS PERIOD 336
TOTAL WITH SUMMARIES 260
TOTAL WITH STATEMENTS 76
Updated 09/23/2002
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