510(k)s Final Decisions Rendered

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horizonal rule
510(k)s Final Decisions Rendered for February 2000

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DEVICE: GENX CULTURE DISH
 INTL., INC.                      510(k) NO: K993881(TRADITIONAL)
ATTN: MICHAEL D CECCHI            PHONE NO : 800-966-6453
170 FORT PATH RD.                 SE DECISION MADE: 14-FEB-00
MADISON, CT 06443                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENX MICROTOOLS
 INTL., INC.                      510(k) NO: K993884(TRADITIONAL)
ATTN: MICHAEL D CECCHI            PHONE NO : 800-966-6453
170 FORT PATH RD.                 SE DECISION MADE: 14-FEB-00
MADISON, CT 06443                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823
A & A MEDICAL, INC.               510(k) NO: K994256(TRADITIONAL)
ATTN: JIHAD  MANSOUR              PHONE NO : 770-343-8400
9370 INDUSTRIAL TRACE             SE DECISION MADE: 03-FEB-00
ALPHARETTA, GA 30004-3383         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: T-2000-POWER TILT SEATING SYSTEM, MODELS ARD-TSTORM, ARD-TP-320,
ACCELERATED REHAB DESIGNS, INC.   510(k) NO: K992804(TRADITIONAL)
ATTN: RANDALL  POTTER             PHONE NO : 281-356-1950
32025 INDUSTRIAL PARK DR.         SE DECISION MADE: 03-FEB-00
PINEHURST, TX 77362               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E-2000 POWER ELEVATING SEAT SYSTEM, MODELS ARD-ESTORM, ARD-EP320
ACCELERATED REHAB DESIGNS, INC.   510(k) NO: K992828(TRADITIONAL)
ATTN: RANDALL  POTTER             PHONE NO : 281-356-1950
32025 INDUSTRIAL PARK DR.         SE DECISION MADE: 03-FEB-00
PINEHURST, TX 77362               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUMED MODULAR SHOULDER SYSTEM
ACUMED, INC.                      510(k) NO: K992525(TRADITIONAL)
ATTN: SHARI  JEFFERS              PHONE NO : 503-627-9957
10950 S.W. 5TH ST., SUITE 170     SE DECISION MADE: 04-FEB-00
BEAVERTON, OR 97005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EX
ADVANCED BIOMEDICAL DEVICES, INC. 510(k) NO: K981936(TRADITIONAL)
ATTN: R. EDWARD  WINTERS          PHONE NO : 978-470-1177
3 DUNDEE PARK                     SE DECISION MADE: 16-FEB-00
ANDOVER, MA 01810                 510(k) STATEMENT

DEVICE: VERIPATH PERIPHERAL GUIDING CATHETER
ADVANCED CARDIOVASCULAR SYSTEMS, I510(k) NO: K994229(SPECIAL)
ATTN: STACEY  SIMON               PHONE NO : 909-914-4527
26531 YNEZ RD.                    SE DECISION MADE: 25-FEB-00
TEMECULA, CA 92591-4628           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUINN'S SPERM WASHING MEDIUM
ADVANCED REPRODUCTIVE TECHNOLOGIES510(k) NO: K991379(TRADITIONAL)
ATTN: GREG  HOLLAND               PHONE NO : 949-262-0411
3722 AVENUE SAUSALITO             SE DECISION MADE: 02-FEB-00
IRVINE, CA 92606                  510(k) STATEMENT

 
DEVICE: HUMAN SERUM ALBUMIN
ADVANCED REPRODUCTIVE TECHNOLOGIES510(k) NO: K991392(TRADITIONAL)
ATTN: GREG  HOLLAND               PHONE NO : 949-262-0411
3722 AVENUE SAUSALITO             SE DECISION MADE: 07-FEB-00
IRVINE, CA 92606                  510(k) STATEMENT

DEVICE: QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL
ADVANCED REPRODUCTIVE TECHNOLOGIES510(k) NO: K991395(TRADITIONAL)
ATTN: GRER  HOLLAND               PHONE NO : 949-262-0411
3722 AVENUE SAUSALITO             SE DECISION MADE: 15-FEB-00
IRVINE, CA 92606                  510(k) STATEMENT

DEVICE: WILTSE SYSTEM
ADVANCED SPINE FIXATION SYSTEMS, I510(k) NO: K992012(TRADITIONAL)
ATTN: GREG  HOLLAND               PHONE NO : 949-262-0411
3722 AVE. SAUSALITO               SE DECISION MADE: 04-FEB-00
IRVINE, CA 92606                  510(k) STATEMENT

DEVICE: TRIPLE-FIX SPINAL FIXATION SYSTEM
ADVANCED SPINE TECHNOLOGY, INC.   510(k) NO: K992147(TRADITIONAL)
ATTN: GORDON  TAO                 PHONE NO : 510-251-6798
3645GRAND AVE., SUITE 304         SE DECISION MADE: 28-FEB-00
OAKLAND, CA 94610                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANTAGE HCG TEST (URINE/SERUM)
ADVANTAGE DIAGNOSTICS CORP.       510(k) NO: K994227(TRADITIONAL)
ATTN: JANIS  FREESTONE            PHONE NO : 650-691-4770
2440 LEGHORN ST.                  SE DECISION MADE: 03-FEB-00
MOUNTAIN VIEW, CA 94043           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
AGFA CORP.                        510(k) NO: K000159(SPECIAL)
ATTN: TIMOTHY W CAPEHART          PHONE NO : 864-421-1834
10 SOUTH ACADEMY ST.              SE DECISION MADE: 16-FEB-00
GREENVILLE, SC 29601              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT
ALLEGIANCE HEALTHCARE CORP.       510(k) NO: K994162(SPECIAL)
ATTN: ERICA  SETHI                PHONE NO : 847-785-3337
1500 WAUKEGAN ROAD BUILDING K     SE DECISION MADE: 09-FEB-00
MCGAW PARK, IL 60085              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONVERTORS SURGICAL GOWNS, STERILE
ALLEGIANCE HEALTHCARE CORP.       510(k) NO: K994244(TRADITIONAL)
ATTN: SHARON  ROBBINS             PHONE NO : 847-785-3311
1500 WAUKEGAN RD.                 SE DECISION MADE: 18-FEB-00
MCGAW PARK, IL 60085              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 10 CURIE IRDIUM 192, CSN00100-192
ALPHA-OMEGA SERVICES, INC.        510(k) NO: K991571(TRADITIONAL)
ATTN: J. HARVEY  KNAUSS           PHONE NO : 713-723-8169
11874 SOUTH EVELYN CIRCLE         SE DECISION MADE: 22-FEB-00
HOUSTON, TX 77071                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: R1000 SERIES INSULIN PUMP
ANIMAS CORPORATION                510(k) NO: K993184(TRADITIONAL)
ATTN: MONICA  FERRANTE            PHONE NO : 610-644-8990
590 E. LANCASTER AVENUE           SE DECISION MADE: 10-FEB-00
FRAZER, PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN
ANSELL PERRY INC.                 510(k) NO: K000295(SPECIAL)
ATTN: JAMES R CHATTERTON          PHONE NO : 330-833-2811
1875 HARSH AVENUE, S.E.           SE DECISION MADE: 16-FEB-00
MASSILLON, OH 44646-7199          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
ARROW INTL., INC.                 510(k) NO: K993966(SPECIAL)
ATTN: WILLIAM  PAQUIN             PHONE NO : 617-389-6400
9 PLYMOUTH ST.                    SE DECISION MADE: 18-FEB-00
EVERETT, MA 02149                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENTEC REFLEX WAND 55, MODEL E4055-00
ARTHROCARE CORP.                  510(k) NO: K000036(TRADITIONAL)
ATTN: BRUCE  PROTHRO              PHONE NO : 408-736-1224
595 NORTH PASTORIA AVE.           SE DECISION MADE: 04-FEB-00
SUNNYVALE, CA 94086               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD,
ARTHROCARE CORP.                  510(k) NO: K000044(SPECIAL)
ATTN: BRUCE  PROTHRO              PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE.           SE DECISION MADE: 01-FEB-00
SUNNYVALE, CA 94086               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD,
ARTHROCARE CORP.                  510(k) NO: K000074(SPECIAL)
ATTN: BETTY M JOHNSON             PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE.           SE DECISION MADE: 04-FEB-00
SUNNYVALE, CA 94086               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENTEC CONTROLLER, ENTEC PATIENT CABLE, FOOTSWITCH, POWERCORD, PL
ARTHROCARE CORP.                  510(k) NO: K000228(SPECIAL)
ATTN: BRUCE  PROTHRO              PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE.           SE DECISION MADE: 22-FEB-00
SUNNYVALE, CA 94086               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO
AVOCET MEDICAL, INC.              510(k) NO: K994006(TRADITIONAL)
ATTN: JILL  FALCONE               PHONE NO : 408-574-6638
100 GREAT OAKS BLVD.              SE DECISION MADE: 03-FEB-00
SAN JOSE, CA 95119                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARCOMED 2MP2
BARCO NV                          510(k) NO: K000015(TRADITIONAL)
ATTN: FRANK  FERGUSON             PHONE NO : 858-587-1147
P.O. BOX 12038                    SE DECISION MADE: 04-FEB-00
LA JOLLA, CA 92039-2038           510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
BAYER CORP.                       510(k) NO: K992662(TRADITIONAL)
ATTN: GABRIEL J MURACA            PHONE NO : 914-524-3494
511 BENEDICT AVE.                 SE DECISION MADE: 15-FEB-00
TARRYTOWN, NY 10591-5097          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 3331
BECKMAN COULTER, INC.             510(k) NO: K000196(TRADITIONAL)
ATTN: JAN  OLSEN                  PHONE NO : 612-368-7688
1000 LAKE HAZELTINE DR.           SE DECISION MADE: 18-FEB-00
CHASKA, MN 55318-1084             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR
BECKMAN COULTER, INC.             510(k) NO: K000331(TRADITIONAL)
ATTN: GAIL  LEFEBVRE              PHONE NO : 714-993-8503
200 S. KRAEMER BLVD., W-104       SE DECISION MADE: 10-FEB-00
BREA, CA 92822-8000               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION
BECKMAN COULTER, INC.             510(k) NO: K993547(TRADITIONAL)
ATTN: RICHARD T ROSS              PHONE NO : 714-961-4912
200 S. KRAEMER BLVD., W-104       SE DECISION MADE: 01-FEB-00
BREA, CA 92822-8000               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION
BECKMAN COULTER, INC.             510(k) NO: K993549(TRADITIONAL)
ATTN: RICHARD T ROSS              PHONE NO : 714-961-4912
200 S. KRAEMER BLVD., W-104       SE DECISION MADE: 01-FEB-00
BREA, CA 92822-8000               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR
BECKMAN COULTER, INC.             510(k) NO: K994168(TRADITIONAL)
ATTN: LUCINDA  STOCKERT           PHONE NO : 714-961-3777
200 S. KRAEMER BLVD., W-104       SE DECISION MADE: 03-FEB-00
BREA, CA 92822-8000               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR
BECKMAN COULTER, INC.             510(k) NO: K994169(TRADITIONAL)
ATTN: LUCINDA  STOCKERT           PHONE NO : 714-961-3777
200 S. KRAEMER BLVD., W-104       SE DECISION MADE: 03-FEB-00
BREA, CA 92822-8000               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-N
BIO-VASCULAR, INC.                510(k) NO: K992537(TRADITIONAL)
ATTN: MARY KAY  KESSINGER SOBCINSKPHONE NO : 651-603-3703
2575 UNIVERSITY AVE., STE.180     SE DECISION MADE: 22-FEB-00
ST. PAUL, MN 55114-1024           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS
BIOCELL LABORATORIES, INC.        510(k) NO: K000056(TRADITIONAL)
ATTN: MARC M MCKONIC              PHONE NO : 310-537-3300
2001 UNIVERSITY DR.               SE DECISION MADE: 24-FEB-00
RANCHO DOMINGUEZ, CA 90220-6411   510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: MEMOGRAPH STAPLE, WARM SYSTEM
BIOMEDICAL ENT., INC.             510(k) NO: K993714(TRADITIONAL)
ATTN: W. CASEY  FOX               PHONE NO : 210-677-0354
14785 OMICRON DR., SUITE 205      SE DECISION MADE: 25-FEB-00
SAN ANTONIO, TX 78245             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PAR 5 ACETABULAR COMPONENT
BIOMET, INC.                      510(k) NO: K000254(SPECIAL)
ATTN: PATRICIA  SANDBORN BERES    PHONE NO : 219-267-6639
P.O. BOX 587                      SE DECISION MADE: 07-FEB-00
WARSAW, IN 46581                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPACT MODULAR TOTAL HIP SYSTEM
BIOMET, INC.                      510(k) NO: K000334(SPECIAL)
ATTN: FRED  MCCLURE               PHONE NO : 219-372-1568
AIRPORT INDUSTRIAL PARK           SE DECISION MADE: 16-FEB-00
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46580

DEVICE: MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM
BIOMET, INC.                      510(k) NO: K000335(SPECIAL)
ATTN: FRED  MCCLURE               PHONE NO : 219-372-1568
AIRPORT INDUSTRIAL PARK           SE DECISION MADE: 25-FEB-00
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46580

DEVICE: DISPOSABLE INFUSION PUMP KIT
BIOMET, INC.                      510(k) NO: K993972(TRADITIONAL)
ATTN: PATRICIA  SANDBORN BERES    PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK           SE DECISION MADE: 07-FEB-00
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46580

DEVICE: MALLORY/HEAD SMOOTH FEMORAL COMPONENT
BIOMET, INC.                      510(k) NO: K994007(TRADITIONAL)
ATTN: TINA  LAKIN                 PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK           SE DECISION MADE: 04-FEB-00
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587

DEVICE: PLR SPLINED REVISION STEM
BIOMET, INC.                      510(k) NO: K994184(TRADITIONAL)
ATTN: TRACY J BICKEL              PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK           SE DECISION MADE: 15-FEB-00
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587

DEVICE: BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FAS
BIONOSTICS INC.                   510(k) NO: K000318(TRADITIONAL)
ATTN: KATHLEEN  STORRO            PHONE NO : 978-263-3856
2 CRAIG RD.                       SE DECISION MADE: 28-FEB-00
ACTON, MA 01720                   510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: 7250 (MEGAS)
BIOSOUND ESAOTE, INC.             510(k) NO: K994369(TRADITIONAL)
ATTN: COLLEEN  HITTLE             PHONE NO : 317-849-1793
8000 CASTLEWAY DR.                SE DECISION MADE: 24-FEB-00
INDIANAPOLIS, IN 46250            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOTEQUE HEMODIALYSIS BLOOD TUBING SET
BIOTEQUE CORP.                    510(k) NO: K992930(TRADITIONAL)
ATTN: ALLEN  REICH                PHONE NO : 520-773-9488
900 N. SWITZER CANYON DR. #142    SE DECISION MADE: 09-FEB-00
FLAGGSTAFF, AZ 86001              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IONTOPATCH
BIRCH POINT MEDICAL, INC.         510(k) NO: K992708(TRADITIONAL)
ATTN: WALTER L SEMBROWICH         PHONE NO : 651-628-0737
2660 PATTON ROAD                  SE DECISION MADE: 01-FEB-00
ROSEVILLE, MN 55113               510(k) STATEMENT

DEVICE: BLACKSTONE SPINAL FIXATION SYSTEM
BLACKSTONE MEDICAL, INC.          510(k) NO: K994217(TRADITIONAL)
ATTN: ALAN  LOMBARDO              PHONE NO : 888-298-5400
90 BROOKSDALE DR.                 SE DECISION MADE: 28-FEB-00
SPRINGFIELD, MA 01104             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO T-REX BIOPSY FORCEPS
BOSTON SCIENTIFIC CORP.           510(k) NO: K000409(SPECIAL)
ATTN: JOCELYN  KERSTEN            PHONE NO : 425-556-1667
17425 NORTH EAST UNION HILL RD    SE DECISION MADE: 28-FEB-00
NORTHWEST TECHNOLOGY CENTER       510(k) SUMMARY AVAILABLE FROM FDA
REDMOND, WA 98052-3376

DEVICE: ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE
CALIFORNIA MEDICAL LABORATORIES, I510(k) NO: K993818(TRADITIONAL)
ATTN: MEHMET  BICAKCI             PHONE NO : 949-553-9414
2681 KELVIN AVENUE                SE DECISION MADE: 08-FEB-00
IRVINE, CA 92614                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K000225(SPECIAL)
ATTN: LEONID  TRACHTENBERG        PHONE NO : 972 894 84600
2 PEKERIS ST., SCIENCE PARK       SE DECISION MADE: 11-FEB-00
P.O.B. 527                        510(k) STATEMENT
REHOVOT, ISRAEL 76100

DEVICE: SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C
CARDIOFOCUS INC.                  510(k) NO: K993834(TRADITIONAL)
ATTN: WILLIAM A KNAPE             PHONE NO : 408-399-9347
987 UNIVERSITY AVENUE             SE DECISION MADE: 04-FEB-00
SUITE 14                          510(k) SUMMARY AVAILABLE FROM FDA
LOS GATOS, CA 95032

DEVICE: HMP CONTROLS (TAS) RAPIDPOINT
CARDIOVASCULAR DIAGNOSTICS, INC.  510(k) NO: K994159(TRADITIONAL)
ATTN: PETER  SCOTT                PHONE NO : 800-247-4234
5301 DEPARTURE DR.                SE DECISION MADE: 15-FEB-00
RALEIGH, NC 27616                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: PR3 ULTRASOUND SYSTEM
CAROLINA MEDICAL, INC.            510(k) NO: K993978(TRADITIONAL)
ATTN: CARROLL L TURNER            PHONE NO : 336-983-5132
157 INDUSTRIAL DR.                SE DECISION MADE: 10-FEB-00
KING, NC 27021                    510(k) STATEMENT

DEVICE: SYNTHETIC VDRL ANTIGEN
CENTERS FOR DISEASE CONTROL       510(k) NO: K993633(TRADITIONAL)
ATTN: VICTORIA  POPE              PHONE NO : 404-639-3224
1600 CLIFTON RD., N.E.            SE DECISION MADE: 23-FEB-00
ATLANTA, GA 30333                 510(k) STATEMENT

DEVICE: CERALAS D10 810NM DIODE LASER
CERAMOPTEC, INC.                  510(k) NO: K993828(TRADITIONAL)
ATTN: CAROL J MORELLO             PHONE NO : 413-525-0600
515 SHAKER ROAD                   SE DECISION MADE: 01-FEB-00
EAST LONGMEADOW, MA 01028         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50
CERAMOPTEC, INC.                  510(k) NO: K993911(TRADITIONAL)
ATTN: CAROL J MORELLO             PHONE NO : 413-525-0600
515 SHAKER ROAD                   SE DECISION MADE: 01-FEB-00
EAST LONGMEADOW, MA 01028         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPOT ENDOSCOPIC MARKER
CHEK-MED SYSTEMS                  510(k) NO: K993951(TRADITIONAL)
ATTN: ROB  WHALEN                 PHONE NO : 860-429-9221
11 PHELPS WAY                     SE DECISION MADE: 18-FEB-00
P.O. BOX 289                      510(k) STATEMENT
WILLINGTON, CT 06279

DEVICE: COALESCENT SURGICAL SUTURED-CLIP
COALESCENT SURGICAL               510(k) NO: K994160(TRADITIONAL)
ATTN: MICHAEL A DANIEL            PHONE NO : 415-407-0223
559 EAST WEDDELL DR.              SE DECISION MADE: 04-FEB-00
SUNNYVALE, CA 94089               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA
COGENT DIAGNOTICS LTD.            510(k) NO: K993085(TRADITIONAL)
ATTN: RANDY  WILSON               PHONE NO : 714-933-3000
7272 CHAPMAN AVENUE               SE DECISION MADE: 01-FEB-00
GARDEN GROVE, CA 92841            510(k) STATEMENT

DEVICE: AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
COGENT DIAGNOTICS LTD.            510(k) NO: K994338(TRADITIONAL)
ATTN: DANIELLE M KNIGHT           PHONE NO : 44 131 4457111
PENTLANDS SCIENCE PARK            SE DECISION MADE: 03-FEB-00
BUSH LOAN, PENICUIK               510(k) STATEMENT
MIDLOTHIAN, SCOTLAND, UNITED KINGDOM EH26 OPL

DEVICE: QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
CONSOLIDATED TECHNOLOGIES INC.    510(k) NO: K000116(TRADITIONAL)
ATTN: RUSTY  SEWELL               PHONE NO : 512-445-5100
2170 WOODWARD, NO. 100            SE DECISION MADE: 15-FEB-00
AUSTIN, TX 78744                  510(k) STATEMENT

 
DEVICE: SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000
CONWAY STUART MEDICAL, INC.       510(k) NO: K000170(SPECIAL)
ATTN: THOMAS C WEHMAN             PHONE NO : 408-733-9910
735 PALOMAR ST.                   SE DECISION MADE: 14-FEB-00
SUNNYVALE, CA 94086               510(k) STATEMENT

DEVICE: ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS
CORIN U.S.A.                      510(k) NO: K000232(SPECIAL)
ATTN: CRAIG  CORRANCE             PHONE NO : 813-977-4469
10500 UNIVERSITY CENTER DR.,      SE DECISION MADE: 25-FEB-00
SUITE 190                         510(k) STATEMENT
TAMPA, FL 33612

DEVICE: CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS
CORIN U.S.A.                      510(k) NO: K994153(TRADITIONAL)
ATTN: CRAIG  CORRANCE             PHONE NO : 813-979-0042
10500 UNIVERSITY CENTER DR.,      SE DECISION MADE: 25-FEB-00
SUITE 190                         510(k) SUMMARY AVAILABLE FROM FDA
TAMPA, FL 33612

DEVICE: DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400
CRITIKON COMPANY,LLC              510(k) NO: K992638(TRADITIONAL)
ATTN: THOMAS  ENGLISH             PHONE NO : 813-887-2107
4110 GEORGE RD.                   SE DECISION MADE: 24-FEB-00
TAMPA, FL 33634                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION TRNF FLEX REAGENT CARTRIDGE
DADE BEHRING, INC.                510(k) NO: K994294(TRADITIONAL)
ATTN: RICHARD M VAUGHT            PHONE NO : 302-631-6537
GLASGOW BUSINESS COMMUNITY;       SE DECISION MADE: 04-FEB-00
BLDG. 500   MAIL BOX 514          510(k) SUMMARY AVAILABLE FROM FDA
P.O. BOX 6101, NEWARK, DE 19714-6101

DEVICE: MICROSTREP PLUS PANEL, LEVOFLOXACIN
DADE MICROSCAN, INC.              510(k) NO: K983943(TRADITIONAL)
ATTN: SHAROLYN J LENTSCH          PHONE NO : 916-374-8183
1584 ENTERPRISE BLVD.             SE DECISION MADE: 18-FEB-00
WEST SACRAMENTO, CA 95691         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NASOGASTRIC TUBE HOLDER, MODEL 160
DALE MEDICAL PRODUCTS, INC.       510(k) NO: K994300(TRADITIONAL)
ATTN: JOHN C BREZACK              PHONE NO : 800-343-3980
7 CROSS ST., P.O. BOX 1556        SE DECISION MADE: 10-FEB-00
PLAINVILLE, MA 02762              510(k) STATEMENT

DEVICE: CD HORIZON SPINAL SYSTEM
DANEK MEDICAL, INC.               510(k) NO: K993810(SPECIAL)
ATTN: RICHARD W TREHARNE          PHONE NO : 901-396-3133
1800 PYRAMID PL.                  SE DECISION MADE: 03-FEB-00
MEMPHIS, TN 38132                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BONE GRAFT WASHER, MODEL 9090114 - 9090118
DANEK MEDICAL, INC.               510(k) NO: K994122(TRADITIONAL)
ATTN: RICHARD W TREHARNE          PHONE NO : 901-396-3133
1800 PYRAMID PL.                  SE DECISION MADE: 18-FEB-00
MEMPHIS, TN 38132                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: DATEX-OHMEDA INOVENT DELIVERY SYSTEM
DATEX-OHMEDA                      510(k) NO: K000186(SPECIAL)
ATTN: DANIEL  KOSEDNAR            PHONE NO : 608-221-1551
PO BOX 7550                       SE DECISION MADE: 10-FEB-00
MADISON, WI 53707                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM
DBA SYSTEMS INC.                  510(k) NO: K992467(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202-637-5794
555 13TH STREET, N.W.             SE DECISION MADE: 10-FEB-00
WASHINGTON, DC 20004              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEFINITE
DEGUSSA - NEY DENTAL, INC.        510(k) NO: K993514(TRADITIONAL)
ATTN: THOMAS B CAMERON            PHONE NO : 800-243-1942
65 WEST DUDLY TOWN RD.            SE DECISION MADE: 24-FEB-00
BLOOMFIELD, CT 06002              510(k) STATEMENT

DEVICE: ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407,
DENTSPLY INTL.                    510(k) NO: K994211(TRADITIONAL)
ATTN: WILLIAM T COUSINS           PHONE NO : 847-640-4924
901 WEST OAKTON ST.               SE DECISION MADE: 04-FEB-00
DES PLAINES, IL 60018-1884        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
DEPUY ORTHOPAEDICS, INC.          510(k) NO: K000172(SPECIAL)
ATTN: CHERYL  HASTINGS            PHONE NO : 219-371-4940
700 ORTHOPAEDIC DR.               SE DECISION MADE: 03-FEB-00
WARSAW, IN 46581-0988             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POROCOAT PRODIGY HIP PROSTHESIS
DEPUY ORTHOPAEDICS, INC.          510(k) NO: K000207(SPECIAL)
ATTN: MARCIA J ARENTZ             PHONE NO : 219-371-4944
700 ORTHOPAEDIC DR.               SE DECISION MADE: 04-FEB-00
WARSAW, IN 46581-0988             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS
DEPUY ORTHOPAEDICS, INC.          510(k) NO: K994415(SPECIAL)
ATTN: CHERYL  HASTINGS            PHONE NO : 219-371-4901
700 ORTHOPAEDIC DR.               SE DECISION MADE: 03-FEB-00
WARSAW, IN 46581-0988             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TEMPOFIT, MODEL 02693
DETAX GMBH & CO. KG               510(k) NO: K994012(TRADITIONAL)
ATTN: BARRY  HALE                 PHONE NO : 816-322-4641
7707 E. 201 TERR                  SE DECISION MADE: 16-FEB-00
BELTON, MO 64012                  510(k) STATEMENT

DEVICE: IMMUNOCYT
DIAGNOCURE, INC.                  510(k) NO: K994356(TRADITIONAL)
ATTN: BRUCE F MACKLER             PHONE NO : 202-785-4747
815 CONNECTICUT AVE, N.W.         SE DECISION MADE: 23-FEB-00
SUITE 200                         510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006-4004

 
DEVICE: CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17
DIAGNOSTIC CHEMICALS LTD.         510(k) NO: K000055(TRADITIONAL)
ATTN: KAREN  CALLBECK             PHONE NO : 902 566 1396
16 MCCARVILLE STREET              SE DECISION MADE: 18-FEB-00
CHARLOTTETOWN, CANADA C1E 2A6     510(k) STATEMENT

DEVICE: IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15
DIAGNOSTIC CHEMICALS LTD.         510(k) NO: K994035(TRADITIONAL)
ATTN: KAREN  CALLBECK             PHONE NO : 902 566 1396
16 MCCARVILLE STREET              SE DECISION MADE: 01-FEB-00
CHARLOTTETOWN, CANADA C1E 2A6     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: YEASTEST
DIAGNOSTIC MARKERS, INC.          510(k) NO: K993554(TRADITIONAL)
ATTN: GREG  HOLLAND               PHONE NO : 949-262-0411
3722 AVE. SAUSALITO               SE DECISION MADE: 10-FEB-00
IRVINE, CA 92606                  510(k) STATEMENT

DEVICE: IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LK
DIAGNOSTIC PRODUCTS CORP.         510(k) NO: K000006(TRADITIONAL)
ATTN: EDWARD M LEVINE             PHONE NO : 310-645-8200
5700 WEST 96TH ST.                SE DECISION MADE: 28-FEB-00
LOS ANGELES, CA 90045             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # L
DIAGNOSTIC PRODUCTS CORP.         510(k) NO: K000007(TRADITIONAL)
ATTN: EDWARD M LEVINE             PHONE NO : 310-645-8200
5700 WEST 96TH ST.                SE DECISION MADE: 28-FEB-00
LOS ANGELES, CA 90045             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6
DIAGNOSTIC PRODUCTS CORP.         510(k) NO: K000257(TRADITIONAL)
ATTN: EDWARD M LEVINE             PHONE NO : 310-645-8200
5700 WEST 96TH ST.                SE DECISION MADE: 23-FEB-00
LOS ANGELES, CA 90045             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM
DIAMEDIX CORP.                    510(k) NO: K994424(TRADITIONAL)
ATTN: LYNNE  STIRLING             PHONE NO : 305-324-2354
2140 NORTH MIAMI AVE.             SE DECISION MADE: 18-FEB-00
MIAMI, FL 33127                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COPALIS RUBELLA IGM
DIASORIN INC.                     510(k) NO: K993291(TRADITIONAL)
ATTN: JUDITH J SMITH              PHONE NO : 301-497-0005
9175 GUILFORD RD., SUITE 100      SE DECISION MADE: 10-FEB-00
QUARRY PARK PLACE                 510(k) SUMMARY AVAILABLE FROM FDA
COLUMBIA, MD 21046

DEVICE: LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O
DIDECO S.P.A.                     510(k) NO: K991737(TRADITIONAL)
ATTN: BARRY  SALL                 PHONE NO : 781-684-9201
1601 TRAPELO ROAD                 SE DECISION MADE: 17-FEB-00
WALTHAM, MA 02154                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: PERCUGUARD
DIGIT-PRO                         510(k) NO: K992539(TRADITIONAL)
ATTN: KEVIN  SORRELS              PHONE NO : 713-983-7778
10555 WEST LITTLE YORK ROAD       SE DECISION MADE: 18-FEB-00
HOUSTON, TX 77041                 510(k) STATEMENT

DEVICE: T-GEAR, MODEL TG/400-700
DONTECH PRODUCTS B.V.             510(k) NO: K993224(TRADITIONAL)
ATTN: JAN  JORENS                 PHONE NO : 003 118 3660055
AVELINGENWEST 27C                 SE DECISION MADE: 11-FEB-00
GORINCHEM, ZH, NETHERLANDS        510(k) STATEMENT

DEVICE: X-RAY MONOBLOCK, MONOBLOCK XRS-60-330
DYNARAD CORP.                     510(k) NO: K000052(TRADITIONAL)
ATTN: RAYMONF  MANEZ              PHONE NO : 516-242-5550
19 JEFRYN BLVD. WEST              SE DECISION MADE: 10-FEB-00
DEER PARK, NY 11729               510(k) STATEMENT

DEVICE: KODAK HOME HEALTH MONITORING SYSTEM
EASTMAN KODAK CO.                 510(k) NO: K983928(TRADITIONAL)
ATTN: JUDITH A WALLACE            PHONE NO : 716-726-6763
901 ELMGROVE RD.                  SE DECISION MADE: 11-FEB-00
ROCHESTER, NY 14653-4757          510(k) STATEMENT

DEVICE: EBI XFIX DFS RAIL SYSTEM
EBI, L.P.                         510(k) NO: K000083(SPECIAL)
ATTN: JONAS  WILF                 PHONE NO : 973-299-9022
100 INTERPACE PKWY.               SE DECISION MADE: 03-FEB-00
PARSIPPANY, NJ 07054-1079         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EBI XFIX DFS SYSTEM
EBI, L.P.                         510(k) NO: K000319(SPECIAL)
ATTN: JONAS  WILF                 PHONE NO : 973-299-9022
100 INTERPACE PKWY.               SE DECISION MADE: 25-FEB-00
PARSIPPANY, NJ 07054-1079         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO ISOBAR SPINAL SYSTEM
ENCORE ORTHOPEDICS, INC.          510(k) NO: K000020(SPECIAL)
ATTN: DEBBIE  DE LOS SANTOS       PHONE NO : 512-834-6237
9800 METRIC BLVD.                 SE DECISION MADE: 03-FEB-00
AUSTIN, TX 78758                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROU
ENCORE ORTHOPEDICS, INC.          510(k) NO: K993943(TRADITIONAL)
ATTN: DEBBIE  DE LOS SANTOS       PHONE NO : 512-834-6237
9800 METRIC BLVD.                 SE DECISION MADE: 04-FEB-00
AUSTIN, TX 78758                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM
ENDIUS INC.                       510(k) NO: K994425(TRADITIONAL)
ATTN: SUSAN  FINNERAN             PHONE NO : 508-643-0983
23 WEST BACON ST.                 SE DECISION MADE: 16-FEB-00
PLAINVILLE, MA 02762              510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: OXYCON PRO
ERICH JAEGER B.V.                 510(k) NO: K992214(TRADITIONAL)
ATTN: LEO DEN  BAKKER             PHONE NO : 313 065 94600
REGULIERENRING 11                 SE DECISION MADE: 22-FEB-00
BUNNIK, NETHERLANDS 3981 LA       510(k) STATEMENT

DEVICE: ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT
ESC MEDICAL SYSTEMS LTD.          510(k) NO: K994014(TRADITIONAL)
ATTN: ZVI  LADIN                  PHONE NO : 781-444-8446
250 FIRST AVENUE                  SE DECISION MADE: 24-FEB-00
NEEDHAM, MA 02194                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GYNECARE LAPAROSCOPIC MORCELLATOR
ETHICON, INC.                     510(k) NO: K993801(TRADITIONAL)
ATTN: GREGORY R JONES             PHONE NO : 908-218-2481
ROUTE 22, WEST                    SE DECISION MADE: 07-FEB-00
P.O. BOX 151                      510(k) SUMMARY AVAILABLE FROM FDA
SOMERVILLE, NJ 08876-0151

DEVICE: REMOTEIMAGE SYSTEM
ETRAUMA, LLC                      510(k) NO: K994228(TRADITIONAL)
ATTN: DAN  HODGEMAN               PHONE NO : 954-421-5623
1425 EAST NEWPORT CENTER DRIVE    SE DECISION MADE: 22-FEB-00
DEERFIELD BEACH, FL 33442         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BITX PROBES
EVEREST MEDICAL CORP.             510(k) NO: K994336(TRADITIONAL)
ATTN: FREDERICK G MADES           PHONE NO : 612-473-6262
13755 FIRST AVE. NORTH, #500      SE DECISION MADE: 08-FEB-00
MINNEAPOLIS, MN 55441-5454        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-S
EXACTECH, INC.                    510(k) NO: K000242(SPECIAL)
ATTN: GARY J MILLER               PHONE NO : 352-377-1140
2320 N.W. 66TH CT.                SE DECISION MADE: 16-FEB-00
GAINESVILLE, FL 32653             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXEL INJECTION PLUG WITH CAP
EXEL INTL.                        510(k) NO: K992290(TRADITIONAL)
ATTN: ARMAND  HAMID               PHONE NO : 310-649-0707
P.O. BOX 3194                     SE DECISION MADE: 23-FEB-00
CULVER CITY, CA 90231-3194        510(k) STATEMENT

DEVICE: EXEL I.V. BLOOD LINE SET
EXELINT INTL. CO.                 510(k) NO: K992039(TRADITIONAL)
ATTN: ARMAND  HAMID               PHONE NO : 310-649-0707
5840 WEST CENTINELA AVE.          SE DECISION MADE: 10-FEB-00
LOS ANGELES, CA 90045             510(k) STATEMENT

DEVICE: POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
FLEXITECH SDN. BHD.               510(k) NO: K994416(TRADITIONAL)
ATTN: Y. F HEW                    PHONE NO : 603 392 0188
LOT 5071, BATU 5 1/2, JALAN       SE DECISION MADE: 03-FEB-00
MERU                              510(k) STATEMENT
KLANG, SELANGOR, MALAYSIA 41050

 
DEVICE: INSTACHECK MULTI-DRUG BAR/BZO TEST, MODEL 205C; INSTACHECK MULTI
FOREFRONT DIAGNOSTICS, INC.       510(k) NO: K994414(ABBREVIATED)
ATTN: FENG-YU  LEE                PHONE NO : 949-595-0673
23561 RIDGE ROUTE DR., SUITE D    SE DECISION MADE: 17-FEB-00
LAGUNA HILLS, CA 92653            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRIOS MICROSAW
FRIADENT GMBH                     510(k) NO: K994298(TRADITIONAL)
ATTN: CAROL  PATTERSON            PHONE NO : 949-462-0900
21911 ERIE LANE                   SE DECISION MADE: 18-FEB-00
LAKE FOREST, CA 92630             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING,
FUJI MEDICAL SYSTEMS U.S.A., INC. 510(k) NO: K993861(TRADITIONAL)
ATTN: JOSEPH M AZARY              PHONE NO : 203-602-3677
419 WEST AVE.                     SE DECISION MADE: 10-FEB-00
STAMFORD, CT 06902                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GASTRO-INTESTINAL SYSTEM EN-410WM
FUJINON, INC.                     510(k) NO: K993704(TRADITIONAL)
ATTN: GARY  ADLER                 PHONE NO : 212-318-7700
399 PARK AVENUE                   SE DECISION MADE: 11-FEB-00
NEW YORK, NY 10022-4689           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRYO-HIT
GALIL MEDICAL LTD.                510(k) NO: K993965(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202-637-5794
555 THIRTEEN ST.                  SE DECISION MADE: 18-FEB-00
WASHINGTON, DC 20004              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COROMETRICS MODEL 173 FETAL MONITOR
GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K993751(TRADITIONAL)
ATTN: RICHARD  CEHOVSKY           PHONE NO : 203-949-8320
61 BARNES PARK RD., NORTH         SE DECISION MADE: 02-FEB-00
WALLINGFORD, CT 06492             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGHTSPEED 2.0CT SCANNER SYSTEM
GE MEDICAL SYSTEMS, INC.          510(k) NO: K000300(TRADITIONAL)
ATTN: LARRY A KROGER              PHONE NO : 262-544-3894
P.O. BOX 414                      SE DECISION MADE: 15-FEB-00
MILWAUKEE, WI 53201               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LCV+ VERSION 2
GE MEDICAL SYSTEMS, INC.          510(k) NO: K993037(TRADITIONAL)
ATTN: LARRY A KROGER              PHONE NO : 414-544-3894
3000 N. GRANDVIEW BLVD.           SE DECISION MADE: 14-FEB-00
WAUKESHA, WI 53188                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE
GENESIS INDUSTRIES, INC.          510(k) NO: K994361(TRADITIONAL)
ATTN: ANGELA  RICHARDSON          PHONE NO : 715-778-5821
303 S. MCKAY AVENUE               SE DECISION MADE: 18-FEB-00
P.O. BOX 39                       510(k) SUMMARY AVAILABLE FROM FDA
SPRING VALLEY, WI 54767

 
DEVICE: GTI-FVIII INHIBITOR ASSAY
GENETIC TESTING INSTITUTE         510(k) NO: K993553(TRADITIONAL)
ATTN: MICHAEL  MOGHADDAM          PHONE NO : 414-792-3900
150 NORTH PATRICK BLVD.           SE DECISION MADE: 01-FEB-00
BROOKFIELD, WI 53045-5837         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CASTLE SERIES 100HC STEAM STERILIZERS
GETINGE/CASTLE, INC.              510(k) NO: K994314(SPECIAL)
ATTN: MARK N SMITH                PHONE NO : 716-272-5013
1777 EAST HENRIETTA RD.           SE DECISION MADE: 16-FEB-00
ROCHESTER, NY 14623-3133          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05,
GRADIPORE LTD.                    510(k) NO: K993332(TRADITIONAL)
ATTN: RHONDA  PILGRIM             PHONE NO : 011 612 98251514
LOT16 RIVERSIDE CORPORATE PARK    SE DECISION MADE: 16-FEB-00
35-105 DELHI ROAD                 510(k) SUMMARY AVAILABLE FROM FDA
NORTH RYDE, AUSTRALIA NSW 2113

DEVICE: RX VIATRAC 14 PERIPHERAL DILATATION CATHETER
GUIDANT CORP.                     510(k) NO: K000101(SPECIAL)
ATTN: KOBBY  DANKWAH              PHONE NO : 408-845-3127
3200 LAKESIDE DR.                 SE DECISION MADE: 10-FEB-00
P.O. BOX 58167                    510(k) SUMMARY AVAILABLE FROM FDA
SANTA CLARA, CA 95054-2807

DEVICE: GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES
GUTHRIE MEDICARE PRODUCTS (NS) SDN510(k) NO: K000090(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 203-431-1511
55 NORTHERN BLVD., SUITE 200      SE DECISION MADE: 10-FEB-00
GREAT NECK, NY 11021              510(k) STATEMENT

DEVICE: HARDYDISK CEFAMANDOLE, 30MCG
HARDY DIAGNOSTICS                 510(k) NO: K000022(TRADITIONAL)
ATTN: MELISSA M TRAYLOR           PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 17-FEB-00
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: HARDYDISK, CEFAZOLIN, 30MCG
HARDY DIAGNOSTICS                 510(k) NO: K000128(TRADITIONAL)
ATTN: MELISSA  TRAYLOR            PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 18-FEB-00
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: HARDYDISK, PIPERACILLIN, 100MCG
HARDY DIAGNOSTICS                 510(k) NO: K000183(TRADITIONAL)
ATTN: MELISSA M TRAYLOR           PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 28-FEB-00
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: HARDYDISK CEFACLOR 30MCG
HARDY DIAGNOSTICS                 510(k) NO: K994046(TRADITIONAL)
ATTN: MELISSA M TRAYLOR           PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 01-FEB-00
SANTA MARIA, CA 93455             510(k) STATEMENT

 
DEVICE: HARDYDISK CHLORAMPHENICOL, 30MCG
HARDY DIAGNOSTICS                 510(k) NO: K994089(TRADITIONAL)
ATTN: MELISSA M TRAYLOR           PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 11-FEB-00
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: HARDYDISK GENTAMICIN, 10MCG
HARDY DIAGNOSTICS                 510(k) NO: K994091(TRADITIONAL)
ATTN: MELISSA M TRAYLOR           PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 11-FEB-00
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: HARDYDISK CEFIXIME, 5MCG
HARDY DIAGNOSTICS                 510(k) NO: K994129(TRADITIONAL)
ATTN: MELISSA M TRAYLOR           PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 11-FEB-00
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: HARDYDISK OXACILLIN, 1MCG
HARDY DIAGNOSTICS                 510(k) NO: K994134(TRADITIONAL)
ATTN: MELISSA M TRAYLOR           PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 17-FEB-00
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: HARDYDISK ERYTHROMYCIN, 15MCG
HARDY DIAGNOSTICS                 510(k) NO: K994135(TRADITIONAL)
ATTN: MELISSA M TRAYLOR           PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 16-FEB-00
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: HARDYDISK NORFLOXACIN, 10MCG
HARDY DIAGNOSTICS                 510(k) NO: K994150(TRADITIONAL)
ATTN: MELISSA M TRAYLOR           PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 16-FEB-00
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: HARDYDISK MEZLOCILLIN 75MCG
HARDY DIAGNOSTICS                 510(k) NO: K994212(TRADITIONAL)
ATTN: MELISSA M TRAYLOR           PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 15-FEB-00
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MON
HEWLETT-PACKARD GMBH              510(k) NO: K993383(ABBREVIATED)
ATTN: EGON  PFEIL                 PHONE NO : 703-114-2243
HERRENBERGER STR. 110-140         SE DECISION MADE: 03-FEB-00
BOEBLINGEN, GERMANY 71034         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERSALET 7700 CARE CENTER, MODEL # 7700
HILL-ROM AIR-SHIELDS              510(k) NO: K993051(TRADITIONAL)
ATTN: JAMES G CARPENTER           PHONE NO : 215-675-5200
330 JACKSONVILLE RD.              SE DECISION MADE: 03-FEB-00
HATBORO, PA 19040                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYST
HORIZON MEDICAL PRODUCTS, INC.    510(k) NO: K994196(TRADITIONAL)
ATTN: JOHN  TARTAL                PHONE NO : 706-846-3126
1 HORIZON WAY                     SE DECISION MADE: 10-FEB-00
MANCHESTER, GA 31816              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HORTMANN ECHOMASTER OAE ANALYZER
HORTMANN AG                       510(k) NO: K994033(TRADITIONAL)
ATTN: BRADFORD  MELANCON          PHONE NO : 512-858-1781
P.O. BOX 1119                     SE DECISION MADE: 24-FEB-00
DRIPPING SPRINGS, TX 78620-1119   510(k) STATEMENT

DEVICE: EXETER CERAMIC FEMORAL HEADS
HOWMEDICA OSTEONICS CORP.         510(k) NO: K993889(TRADITIONAL)
ATTN: NANCY J RIEDER              PHONE NO : 201-507-7956
359 VETERANS BLVD.                SE DECISION MADE: 11-FEB-00
RUTHERFORD, NJ 07070-2584         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CO
HWA TEH INDUSTRIAL SDN. BHD.      510(k) NO: K994432(TRADITIONAL)
ATTN: K.  KARUNAKARAN             PHONE NO : 603 871 7351
LOT 187, SUNGAI DAHAR             SE DECISION MADE: 16-FEB-00
45600 BATANG BERJUNTAI            510(k) STATEMENT
SELANGOR DARUL EHSAN, MALAYSIA 45600

DEVICE: I-STAT SYSTEM
I-STAT CORP.                      510(k) NO: K992571(TRADITIONAL)
ATTN: PAUL  VANDERWERF            PHONE NO : 609-443-9300
104 WINDSOR CENTER DR.            SE DECISION MADE: 10-FEB-00
EAST WINDSOR, NJ 08520            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUPER TISSUE
I.Z.I. CORP.                      510(k) NO: K993742(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 410-451-0639
P.O. BOX 4321                     SE DECISION MADE: 02-FEB-00
CROFTON, MD 21114                 510(k) STATEMENT

DEVICE: MR ENHANCER
I.Z.I. CORP.                      510(k) NO: K994117(TRADITIONAL)
ATTN: E. J SMITH                  PHONE NO : 410-451-0639
P.O. BOX 4321                     SE DECISION MADE: 04-FEB-00
CROFTON, MD 21114                 510(k) STATEMENT

DEVICE: 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM
IMPLANT INNOVATIONS, INC.         510(k) NO: K994148(TRADITIONAL)
ATTN: WILLIAM G CONETY            PHONE NO : 561-776-6819
4555 RIVERSIDE DR.                SE DECISION MADE: 01-FEB-00
PALM BEACH GARDENS, FL 33410      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR ST
IMPLEX CORP.                      510(k) NO: K994076(TRADITIONAL)
ATTN: JOHN  SCHALAGO              PHONE NO : 201-818-1800
80 COMMERCE DR.                   SE DECISION MADE: 18-FEB-00
ALLENDALE, NJ 07401-1600          510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: ULTRACLIP TISSUE MARKER
INRAD                             510(k) NO: K993785(TRADITIONAL)
ATTN: JOSEPH M MAZUREK            PHONE NO : 616-554-7750
3956 44TH ST., S.E.               SE DECISION MADE: 04-FEB-00
KENTWOOD, MI 49512                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IBC VRV, MODEL 1350
INTERNATIONAL BIOPHYSICS CORP.    510(k) NO: K992657(TRADITIONAL)
ATTN: H. DAVID  SHOCKLEY, JR.     PHONE NO : 512-326-3244
4020 SOUTH INDUSTRIAL DR.         SE DECISION MADE: 18-FEB-00
SUITE 160                         510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78744

DEVICE: SYNERGY VLS CAP NUT MODELS 2206, 6102
INTERPORE CROSS INTL.             510(k) NO: K000236(SPECIAL)
ATTN: LYNN M RODARTI              PHONE NO : 949-453-3200
181 TECHNOLOGY DR.                SE DECISION MADE: 16-FEB-00
IRVINE, CA 92618-2402             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRASTENT DOUBLESTRUT LD
INTRATHERAPEUTICS, INC.           510(k) NO: K993904(TRADITIONAL)
ATTN: CATHY  YOHNK                PHONE NO : 612-697-2003
651 CAMPUS DR.                    SE DECISION MADE: 01-FEB-00
ST. PAUL, MN 55112-3495           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACTION AF-1 WHEELCHAIR
INVACARE CORP.                    510(k) NO: K000174(TRADITIONAL)
ATTN: EDWARD A KROLL              PHONE NO : 440-329-6595
P.O. BOX 4028                     SE DECISION MADE: 18-FEB-00
ELYRIA, OH 44036-2125             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JE 2000
JACK'S ELECTRODES                 510(k) NO: K993878(TRADITIONAL)
ATTN: ANTHONY R.H.  FENDER        PHONE NO : 626-798-3913
2227 EAST CRESCENT DR.            SE DECISION MADE: 01-FEB-00
ALTADENA, CA 91001                510(k) STATEMENT

DEVICE: RX G-UNIVERSAL
JENERIC/PENTRON, INC.             510(k) NO: K000360(TRADITIONAL)
ATTN: ANNMARIE  TENERO            PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD.    SE DECISION MADE: 18-FEB-00
P.O. BOX 724                      510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492-0724

DEVICE: OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS
JENERIC/PENTRON, INC.             510(k) NO: K994435(TRADITIONAL)
ATTN: ANNMARIE  TENERO            PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD.    SE DECISION MADE: 10-FEB-00
P.O. BOX 724                      510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492-0724

DEVICE: MED-GUARD SURGEON'S GOWN
KAPPLER USA                       510(k) NO: K992445(TRADITIONAL)
ATTN: PHILIP C MANN               PHONE NO : 256-505-4166
70 GRIMES DR.                     SE DECISION MADE: 18-FEB-00
GUNTERSVILLE, AL 35976            510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: KSEA RIGID CULDOSCOPE AND ACCESSORIES
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K993804(TRADITIONAL)
ATTN: KEVIN A KENNAN              PHONE NO : 310-410-2769
600 CORPORATE POINTE              SE DECISION MADE: 07-FEB-00
CULVER CITY, CA 90230-7600        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KARL STORZ AUTOCLAVABLE CAMERA HEAD
KARL STORZ IMAGING, INC.          510(k) NO: K994090(TRADITIONAL)
ATTN: TERRY  FERNANDEZ            PHONE NO : 805-968-5563
175 CREMONA DR.                   SE DECISION MADE: 04-FEB-00
GOLETA, CA 93117                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80
KATECHO, INC.                     510(k) NO: K993745(TRADITIONAL)
ATTN: WARREN R WALTERS            PHONE NO : 515-244-1212
2500 BELL AVE.                    SE DECISION MADE: 03-FEB-00
P.O. BOX 21247                    510(k) STATEMENT
DES MOINES, IA 50321

DEVICE: AUDIOSCREENER OAE
KEDLY INC.                        510(k) NO: K000184(TRADITIONAL)
ATTN: RANDALL J KROHN             PHONE NO : 636-349-7770
920 S. HIGHWAY DRIVE              SE DECISION MADE: 11-FEB-00
ST. LOUIS, MO 63026               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES
KLS-MARTIN L.P.                   510(k) NO: K994154(TRADITIONAL)
ATTN: ARTHUR  WARD                PHONE NO : 813-376-4154
3234 ELLA LANE                    SE DECISION MADE: 15-FEB-00
NEW PORT RICHEY, FL 34655         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GRE
LATEXX PARTNERS, INC.             510(k) NO: K993912(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 410-451-0639
PO BOX 4341                       SE DECISION MADE: 09-FEB-00
CROFTON, MD 21114                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRABLATOR ELECTRODE
LINVATEC CORP.                    510(k) NO: K993885(TRADITIONAL)
ATTN: LAURA  SENEFF               PHONE NO : 727-392-6464
11311 CONCEPT BLVD.               SE DECISION MADE: 10-FEB-00
LARGO, FL 33773-4908              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOYAGER 6.0 SOFTWARE OPTION
MARCONI MEDICAL SYSTEMS           510(k) NO: K000310(SPECIAL)
ATTN: ELAINE K KEELER             PHONE NO : 440-483-5591
595 MINER RD.                     SE DECISION MADE: 15-FEB-00
HIGHLAND HEIGHTS, OH 44143        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTIFICIAL TEETH (ACRYLIC TEETH)
MASTERDENT LTDA.                  510(k) NO: K992854(TRADITIONAL)
ATTN: JUAN FERNANDO  SALAZAR      PHONE NO : 305-888-6557
7150 N.W. 72 AVE                  SE DECISION MADE: 07-FEB-00
MIAMI, FL 33166                   510(k) STATEMENT

 
DEVICE: MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1
MEDEFIL, INC.                     510(k) NO: K993515(TRADITIONAL)
ATTN: PRADEEP  AGGARWAL           PHONE NO : 847-895-3000
492 LUNT AVENUE                   SE DECISION MADE: 25-FEB-00
SCHAUMBURG, IL 60193              510(k) STATEMENT

DEVICE: MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE
MEDI-CULT A/S                     510(k) NO: K991329(TRADITIONAL)
ATTN: RONALD G LEONARDI           PHONE NO : 619-586-0751
9915 CAM. CHIRIMOLLA              SE DECISION MADE: 25-FEB-00
SAN DIEGO, CA 92131               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDI-CULT LIQUID PARAFFIN
MEDI-CULT A/S                     510(k) NO: K991330(TRADITIONAL)
ATTN: RONALD  LEONARDI            PHONE NO : 619-586-0751
9915 CAM. CHIRIMOLLA              SE DECISION MADE: 25-FEB-00
SAN DIEGO, CA 92131               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDI-CULT SPERM FREEZE MEDIUM
MEDI-CULT A/S                     510(k) NO: K991333(TRADITIONAL)
ATTN: RONALD G LEONARDI           PHONE NO : 619-586-0751
9915 CAM. CHIRIMOLLA              SE DECISION MADE: 28-FEB-00
SAN DIEGO, CA 92131               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDI-CULT FREEZING & THAWING PACKS
MEDI-CULT A/S                     510(k) NO: K991335(TRADITIONAL)
ATTN: RTONALD G LEONARDI          PHONE NO : 619-586-0751
9915 CAM. CHIRIMOLLA              SE DECISION MADE: 28-FEB-00
SAN DIEGO, CA 92131               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASY CARE AND TUBING SETS
MEDIONICS INTERNATIONAL INC.      510(k) NO: K994218(SPECIAL)
ATTN: MAHESH A GARWAL             PHONE NO : 905 472 6544
114 ANDERSON AVE.                 SE DECISION MADE: 10-FEB-00
MARKHAM, ONTARIO, CANADA L6E 1A5  510(k) STATEMENT

DEVICE: AMBIDERM POWDERFREE LATEX EXAMINATION GLOVES WITH A PROTEIN CLAI
MEDTAXX PARTNERS                  510(k) NO: K994131(TRADITIONAL)
ATTN: E. J SMITH                  PHONE NO : 410-451-0639
P.O. BOX 4341                     SE DECISION MADE: 07-FEB-00
CROFTON, MD 21114                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE
MEDTRONIC CARDIAC SURGICAL PRODUCT510(k) NO: K000274(SPECIAL)
ATTN: JAMES  BALUN                PHONE NO : 616-643-5283
620 WATSON S.W.                   SE DECISION MADE: 10-FEB-00
GRAND RAPIDS, MI 49504            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEURO URODYNAMIC SUITE, MODEL 9032E0101
MEDTRONIC FUNCTIONAL DIAGNOSTICS A510(k) NO: K992715(TRADITIONAL)
ATTN: ANN-CHRISTINE  JONSSON      PHONE NO : 454 457 9000
16-18 TONSBAKKEN                  SE DECISION MADE: 28-FEB-00
SKOVLUNDE, DENMARK DK-2740        510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, USA      510(k) NO: K000094(SPECIAL)
ATTN: RICHARD W TREHARNE          PHONE NO : 901-396-3133
1800 PYRAMID PLACE                SE DECISION MADE: 08-FEB-00
MEMPHIS, TN 38132                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT
MEDTRONIC, INC.                   510(k) NO: K000210(SPECIAL)
ATTN: MICHAEL  JOHNSON            PHONE NO : 612-514-9835
4000 LEXINGTON AVE. N             SE DECISION MADE: 23-FEB-00
SHOREVIEW, MN 55126-2983          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CA
MEDTRONIC, INC.                   510(k) NO: K000379
ATTN: MARIE  HOLM                 PHONE NO : 612-779-9183
4633 EAST LA PALMA AVE.           SE DECISION MADE: 16-FEB-00
ANAHEIM, CA 92807                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER
MEDTRONIC, INC.                   510(k) NO: K000430(SPECIAL)
ATTN: DEBRA  KRIDNER              PHONE NO : 714-779-3650
4633 EAST LA PALMA AVENUE         SE DECISION MADE: 25-FEB-00
ANAHEIM, CA 92807                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDX INTECAM INTERFACE
MEDX, INC.                        510(k) NO: K993893(TRADITIONAL)
ATTN: FLOYD  ROWAN                PHONE NO : 847-463-2020
3456 N. RIDGE AVE., #100          SE DECISION MADE: 10-FEB-00
ARLINGTON HEIGHTS, IL 60004       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MERETEK UBT_LITE BREATH TEST FOR H. PYLORI
MERETEK                           510(k) NO: K000316(SPECIAL)
ATTN: KERRY  BUSH                 PHONE NO : 615-333-6336
618 GRASSMERE PARK DRIVE          SE DECISION MADE: 24-FEB-00
SUITE 20                          510(k) SUMMARY AVAILABLE FROM FDA
NASHVILLE, TN 37211

DEVICE: ISOCENTRIC BEAM CHECKER
MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K993959(TRADITIONAL)
ATTN: FELIX  MICK                 PHONE NO : 718-567-3999
1470 OUTLOOK AVE.                 SE DECISION MADE: 14-FEB-00
BRONX, NY 10465                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERMA-DOC PHANTOM
MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K993960(TRADITIONAL)
ATTN: FELIX  MICK                 PHONE NO : 718-567-3999
1470 OUTLOOK AVE.                 SE DECISION MADE: 14-FEB-00
BRONX, NY 10465                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRO-TORQ
MICRO MOTORS, INC.                510(k) NO: K000120(SPECIAL)
ATTN: GREG  HOLLAND               PHONE NO : 949-262-0411
3722 AVE. SAUSALITO               SE DECISION MADE: 03-FEB-00
IRVINE, CA 92606-1849             510(k) STATEMENT

 
DEVICE: MA-300 ELECTROMYOGRAPHY SYSTEM
MOTION LAB SYSTEMS, INC.          510(k) NO: K000220(TRADITIONAL)
ATTN: EDMUND  CRAMP               PHONE NO : 225-928-4248
4326 PINE PARK DR.                SE DECISION MADE: 24-FEB-00
BATON ROUGE, LA 70809-2397        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KAC-63 KNEE ARRAY COIL
MRI DEVICES CORP.                 510(k) NO: K993898(TRADITIONAL)
ATTN: THOMAS  SCHUBERT            PHONE NO : 414-524-1402
N8 W22520 JOHNSON DR., UNIT K     SE DECISION MADE: 04-FEB-00
JOHNSON DR., CORPORATE CENTER     510(k) STATEMENT
WAUKESHA, WI 53186

DEVICE: HSV-2 ELISA IGG, MODEL EL0920G
MRL DIAGNOSTICS                   510(k) NO: K993724(TRADITIONAL)
ATTN: MICHAEL J WAGNER            PHONE NO : 714-220-1900
10703 PROGRESS WAY                SE DECISION MADE: 01-FEB-00
CYPRESS, CA 90630-4737            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HSV-1 ELISA IGG, MODEL EL0910G
MRL DIAGNOSTICS                   510(k) NO: K993754(TRADITIONAL)
ATTN: MICHAEL J WAGNER            PHONE NO : 714-220-1900
10703 PROGRESS WAY                SE DECISION MADE: 09-FEB-00
CYPRESS, CA 90630-4737            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I.CO.S SCREW
NEWDEAL S.A.                      510(k) NO: K993762(TRADITIONAL)
ATTN: NORMAN F ESTRIN             PHONE NO : 301-519-1098
9109 COPENHAVER DRIVE             SE DECISION MADE: 04-FEB-00
POTOMAC, MD 20854                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAC' PIN
NEWDEAL S.A.                      510(k) NO: K993910(TRADITIONAL)
ATTN: NORMAN F ESTRIN             PHONE NO : 301-519-1098
9109 COPENHAVER DRIVE             SE DECISION MADE: 01-FEB-00
POTOMAC, MD 20854                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
NIKOMED U.S.A., INC.              510(k) NO: K000079(SPECIAL)
ATTN: ELAINE  DUNCAN              PHONE NO : 715-549-6035
P.O. BOX 560                      SE DECISION MADE: 04-FEB-00
STILLWATER, MN 55082              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIPRO INSULIN SYRINGE
NIPRO MEDICAL CORP.               510(k) NO: K000144(TRADITIONAL)
ATTN: GARY  GOLDSMITH             PHONE NO : 888-647-7698
3150 NW 107TH AVE.                SE DECISION MADE: 11-FEB-00
MIAMI, FL 33172                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIPRO BLOOD COLLECTION NEEDLE
NIPRO MEDICAL CORP.               510(k) NO: K992699(TRADITIONAL)
ATTN: KAELYN  HADLEY              PHONE NO : 606-224-8256
1384 COPPERFIELD COURT            SE DECISION MADE: 14-FEB-00
LEXINGTON, KY 40514-1268          510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754,
NMT MEDICAL, INC.                 510(k) NO: K994191(TRADITIONAL)
ATTN: RONALD D ARKIN              PHONE NO : 770-565-6166
1733 CANTON LN                    SE DECISION MADE: 08-FEB-00
MARIETTA, GA 30062                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MARSPO2, MODEL 2001
NOVAMETRIX MEDICAL SYSTEMS, INC.  510(k) NO: K993979(ABBREVIATED)
ATTN: ROBERT H SCHIFFMAN          PHONE NO : 203-265-7701
56 CARPENTER LANE                 SE DECISION MADE: 22-FEB-00
WALLINGFORD, CT 06492             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM
OPTIMAL IMAGING SYSTEMS INC.      510(k) NO: K000034(TRADITIONAL)
ATTN: JORGE  MILLIAN              PHONE NO : 305-717-0039
9344 NW 13TH STREET               SE DECISION MADE: 24-FEB-00
SUITE 200                         510(k) SUMMARY AVAILABLE FROM FDA
MIAMI, FL 33172

DEVICE: ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)
ORATEC INTERVENTIONS, INC.        510(k) NO: K992805(TRADITIONAL)
ATTN: JENNIFER  BRENNAN           PHONE NO : 650-369-9904
3700 HAVEN CT.                    SE DECISION MADE: 04-FEB-00
MENLO PARK, CA 94025              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BACT/ALERT SV
ORGANON TEKNIKA CORP.             510(k) NO: K994343(TRADITIONAL)
ATTN: REBECCA A RIVAS             PHONE NO : 919-620-2288
100 AKZO AVE.                     SE DECISION MADE: 10-FEB-00
DURHAM, NC 27712                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DRYSPOT E.COLI 0157 KIT
OXOID, LTD.                       510(k) NO: K993401(TRADITIONAL)
ATTN: AMANDA  SHEPPARD            PHONE NO : 441 256 841144
WADE RD.                          SE DECISION MADE: 28-FEB-00
BASINGSTOKE, HAMPSHIRE, UNITED KIN510(k) STATEMENT

DEVICE: LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE
P.T. MAJA AGUNG LATEXINDO         510(k) NO: K994255(TRADITIONAL)
ATTN: EMMY  TJOENG                PHONE NO : 626-913-1798
889 SOUTH AZUSA AVENUE            SE DECISION MADE: 07-FEB-00
INDUSTRY, CA 91748                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED
P.T. VONIX LATEXINDO CONDOM (RUBBE510(k) NO: K993779(ABBREVIATED)
ATTN: VIJAY  MAHAL                PHONE NO : 617-973-7157
7 RIVERVIEW ROAD                  SE DECISION MADE: 02-FEB-00
FRAMINGHAM, MA 01701              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED
P.T. VONIX LATEXINDO CONDOM (RUBBE510(k) NO: K993781(ABBREVIATED)
ATTN: VIJAY  MAHAL                PHONE NO : 617-973-7157
7 RIVERVIEW ROAD                  SE DECISION MADE: 02-FEB-00
FRAMINGHAM, MA 01701              510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOX
P.T. VONIX LATEXINDO CONDOM (RUBBE510(k) NO: K993782(ABBREVIATED)
ATTN: VIJAY  MAHAL                PHONE NO : 617-973-7157
7 RIVERVIEW ROAD                  SE DECISION MADE: 02-FEB-00
FRAMINGHAM, MA 01701              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PACIFIC HEMOSTASIS THROMBOPLASTIN D
PACIFIC HEMOSTASIS                510(k) NO: K994100(TRADITIONAL)
ATTN: LAURA A WORFOLK             PHONE NO : 800-528-0494
11515 VANSTORY DR.                SE DECISION MADE: 18-FEB-00
HUNTERSVILLE, NC 28078-8144       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAM
PAMITEX INDUSTRIES SDN BHD        510(k) NO: K993918(TRADITIONAL)
ATTN: SAID  AWANG                 PHONE NO : 011 606 6313122
2 1/2 MILES, JALAN RASAH          SE DECISION MADE: 10-FEB-00
SEREMBAN, NAGERI SEMBILAN         510(k) STATEMENT
DARUL KHUSUS, MALAYSIA 70300

DEVICE: RESIN TOOTH BONDING AGENT
PARKELL, INC.                     510(k) NO: K994302(TRADITIONAL)
ATTN: NELSON J GENDUSA            PHONE NO : 631-249-1134
155 SCHMITT BLVD.                 SE DECISION MADE: 07-FEB-00
P.O. BOX 376                      510(k) SUMMARY AVAILABLE FROM FDA
FARMINGDALE, NY 11735

DEVICE: RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES W
PERUSAHAAN PELINDUNG GETAH (M) SDN510(k) NO: K994201(TRADITIONAL)
ATTN: PETER YEW  NIENG CHOON      PHONE NO : 606 677 2781
LOT 110, LORONG SENAWANG 4/3      SE DECISION MADE: 07-FEB-00
SENAWANG INDUSTRIAL ESTATE        510(k) SUMMARY AVAILABLE FROM FDA
SEREMBAN, MALAYSIA 70450

DEVICE: QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
PHAMATECH                         510(k) NO: K000131(SPECIAL)
ATTN: CARL A MONGIOVI             PHONE NO : 858-635-5840
9265 ACTIVITY RD., #112-113       SE DECISION MADE: 04-FEB-00
SAN DIEGO, CA 92126               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8,
PHARMACIA & UPJOHN CO.            510(k) NO: K000132(TRADITIONAL)
ATTN: KAREN E MATIS               PHONE NO : 614-794-3324
5094 ST. ANDREWS DRIVE            SE DECISION MADE: 18-FEB-00
WESTERVILLLE, OH 43082            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTURIS SUITE
PHILIPS MEDICAL SYSTEMS, INC.     510(k) NO: K994210(TRADITIONAL)
ATTN: FRANK  GIANELLI             PHONE NO : 203-926-7031
710 BRIDGEPORT AVENUE             SE DECISION MADE: 04-FEB-00
P.O. BOX 860                      510(k) SUMMARY AVAILABLE FROM FDA
SHELTON, CT 06484

 
DEVICE: GLORY
PILLAR TECHNOLOGY, INC.           510(k) NO: K994127(TRADITIONAL)
ATTN: CHRIS  TINSLEY              PHONE NO : 316-325-2629
1101 ILLINOIS                     SE DECISION MADE: 03-FEB-00
NEODESHA, KS 66757                510(k) STATEMENT

DEVICE: PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMP
PLAYTIME PRODUCTS, INC.           510(k) NO: K993794(TRADITIONAL)
ATTN: MARK  ROSENGARTEN           PHONE NO : 201-785-8040
TECHNICAL CENTER                  SE DECISION MADE: 07-FEB-00
75 COMMERCE DRIVE                 510(k) SUMMARY AVAILABLE FROM FDA
ALLENDALE, NJ 07401-1600

DEVICE: THE MARGRON HIP REPLACEMENT SYSTEM
PORTLAND ORTHOPAEDICS PTY. LTD.   510(k) NO: K992815(TRADITIONAL)
ATTN: RONALD  SEKEL               PHONE NO : 612 958 82121
SUITE 3 LEVEL 5 ST. GEORGE        SE DECISION MADE: 07-FEB-00
PRIVATE HOSPITAL 1 SOUTH ST.      510(k) SUMMARY AVAILABLE FROM FDA
KOGARAH, NEW SOUTH WALES, AUSTRALIA NSW 2217

DEVICE: PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER,
PROBLEM SOLVING CONCEPTS, INC.    510(k) NO: K993750(TRADITIONAL)
ATTN: THOMAS M MCCLELLAND         PHONE NO : 317-848-7431
1980 E. 116TH STREET              SE DECISION MADE: 02-FEB-00
SUITE 220                         510(k) SUMMARY AVAILABLE FROM FDA
CARMEL, IN 46032

DEVICE: PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WIT
PULPDENT CORP.                    510(k) NO: K994182(TRADITIONAL)
ATTN: KENNETH J BERK              PHONE NO : 617-926-6666
80 OAKLAND ST.                    SE DECISION MADE: 23-FEB-00
WATERTOWN, MA 02471-0780          510(k) STATEMENT

DEVICE: MU PLUS
RAD THERAPY SOLUTIONS, INC.       510(k) NO: K992689(TRADITIONAL)
ATTN: STEVE  GRUSE                PHONE NO : 904-441-7400
738 ALDEN DRIVE                   SE DECISION MADE: 10-FEB-00
ORMOND BEACH, FL 32176            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PA
RD MEDICAL MFG., INC.             510(k) NO: K000017(ABBREVIATED)
ATTN: CARLOS A RODRIQUEZ          PHONE NO : 787-742-3800
BO. FULLADOSA                     SE DECISION MADE: 10-FEB-00
CULEBRA, PR 00775                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND
REMED PHARMA                      510(k) NO: K993390(ABBREVIATED)
ATTN: E.J.  SMITH                 PHONE NO : 410-451-0639
PO BOX 4341                       SE DECISION MADE: 14-FEB-00
CROFTON, MD 21114                 510(k) STATEMENT

DEVICE: REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AN
REMED PHARMA                      510(k) NO: K993395(ABBREVIATED)
ATTN: E.J.  SMITH                 PHONE NO : 410-451-0639
PO BOX 4341                       SE DECISION MADE: 15-FEB-00
CROFTON, MD 21114                 510(k) STATEMENT

 
DEVICE: REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT
REMED PHARMA                      510(k) NO: K993396(ABBREVIATED)
ATTN: E.J.  SMITH                 PHONE NO : 410-451-0639
PO BOX 4341                       SE DECISION MADE: 15-FEB-00
CROFTON, MD 21114                 510(k) STATEMENT

DEVICE: REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMM
REMED PHARMA                      510(k) NO: K993404(ABBREVIATED)
ATTN: E.J.  SMITH                 PHONE NO : 410-451-0639
PO BOX 4341                       SE DECISION MADE: 15-FEB-00
CROFTON, MD 21114                 510(k) STATEMENT

DEVICE: REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT
REMED PHARMA                      510(k) NO: K993405(ABBREVIATED)
ATTN: E.J.  SMITH                 PHONE NO : 410-451-0639
PO BOX 4341                       SE DECISION MADE: 15-FEB-00
CROFTON, MD 21114                 510(k) STATEMENT

DEVICE: REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT
REMED PHARMA                      510(k) NO: K993408(ABBREVIATED)
ATTN: E.J.  SMITH                 PHONE NO : 410-451-0639
PO BOX 4341                       SE DECISION MADE: 15-FEB-00
CROFTON, MD 21114                 510(k) STATEMENT

DEVICE: ACCU-CHEK COMPLETE METER
ROCHE DIAGNOSTICS CORP.           510(k) NO: K000364(SPECIAL)
ATTN: MIKE  FLIS                  PHONE NO : 800-428-5074
9115 HAGUE RD.                    SE DECISION MADE: 23-FEB-00
INDIANAPOLIS, IN 46250-0457       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCU-CHEK ADVANTAGE METER
ROCHE DIAGNOSTICS CORP.           510(k) NO: K000365(SPECIAL)
ATTN: MIKE  FLIS                  PHONE NO : 800-428-5074
9115 HAGUE RD.                    SE DECISION MADE: 23-FEB-00
INDIANAPOLIS, IN 46250-0457       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMBRYON TRANSFER CATHETERS/SETS
ROCKET MEDICAL PLC                510(k) NO: K994327(TRADITIONAL)
ATTN: LES  TODD                   PHONE NO : 011 441 914166776
TYNE & WEAR                       SE DECISION MADE: 28-FEB-00
WASHINGTON, UNITED KINGDOM NE37 1N510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MRS-TITAN
ROTEC MEDIZINTECHNIK GMBH         510(k) NO: K992359(TRADITIONAL)
ATTN: ING ULRICH  HOLZWARTH       PHONE NO : 499 135 3215
AM MUHLBERG 31                    SE DECISION MADE: 18-FEB-00
WEISENDORF, GERMANY D-91084       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLOCATH
RUSCH INTL.                       510(k) NO: K000070(TRADITIONAL)
ATTN: KARENANN J BROZOWSKI        PHONE NO : 603-532-7706
TALL PINES PARK                   SE DECISION MADE: 18-FEB-00
JAFFREY, NH 03452                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGIL
RUSCH INTL.                       510(k) NO: K993786(TRADITIONAL)
ATTN: KARENANN J BROZOWSKI        PHONE NO : 603-532-7706
TALL PINES PARK                   SE DECISION MADE: 02-FEB-00
JAFFREY, NH 03452                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYALURONIDASE, 80 U/ML
SAGE BIOPHARMA                    510(k) NO: K991393(TRADITIONAL)
ATTN: GREG  HOLLAND               PHONE NO : 949-262-0411
3722 AVE. SAUSALITO               SE DECISION MADE: 02-FEB-00
IRVINE, CA 92606                  510(k) STATEMENT

DEVICE: WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L
SAGE BIOPHARMA                    510(k) NO: K991396(TRADITIONAL)
ATTN: GREG  HOLLAND               PHONE NO : 949-262-0411
3722 AVE. SAUSALITO               SE DECISION MADE: 15-FEB-00
IRVINE, CA 92606                  510(k) STATEMENT

DEVICE: EU-TTG IGA ELISA
SCIMEDX CORP.                     510(k) NO: K994379(TRADITIONAL)
ATTN: GARY  LEHNUS                PHONE NO : 973-625-8822
400 FORD RD.                      SE DECISION MADE: 18-FEB-00
DENVILLE, NJ 07834                510(k) STATEMENT

DEVICE: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS
SEIN ELECTRONICS CO., LTD.        510(k) NO: K991397(TRADITIONAL)
ATTN:                             PHONE NO :
1540 BARCLAY BLVD.                SE DECISION MADE: 11-FEB-00
BUFFALO GROVE, IL 60089           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
SENDX MEDICAL, INC.               510(k) NO: K994346(TRADITIONAL)
ATTN: MARTIN  SELLERS             PHONE NO : 760-603-3407
1945 PALOMAR OAKS WAY             SE DECISION MADE: 01-FEB-00
CARLSBAD, CA 92009                510(k) STATEMENT

DEVICE: POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES
SHANGHAI CHAMPION PLASTIC PRODUCTS510(k) NO: K994136(TRADITIONAL)
ATTN: JANNA P TUCKER              PHONE NO : 775-342-2612
198 AVE. DE LA D' EMERALD         SE DECISION MADE: 03-FEB-00
SPARKS, NV 89434-9550             510(k) STATEMENT

DEVICE: SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES
SHANGHAI POSEIDON PLASTIC PRODUCTS510(k) NO: K992979(TRADITIONAL)
ATTN: JULIA  WU                   PHONE NO : 862 162 095147
NO. 1 NEW DISTRICT                SE DECISION MADE: 09-FEB-00
ZHU HANG CHEN                     510(k) STATEMENT
JINSHAN HSIEN, SHANGHAI, CHINA

DEVICE: POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA
SHEN WEI (USA), INC.              510(k) NO: K993876(TRADITIONAL)
ATTN: BELLE L CHOU                PHONE NO : 510-429-8692
2845 WHIPPLE RD.                  SE DECISION MADE: 07-FEB-00
UNION CITY, CA 94587              510(k) STATEMENT

 
DEVICE: SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LA
SHIELD GLOVES MANUFACTURER (M) SDN510(k) NO: K000156(TRADITIONAL)
ATTN: JANNA P TUCKER              PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD        SE DECISION MADE: 18-FEB-00
SPARKS, NV 89434-9550             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LAT
SHIELD GLOVES MANUFACTURER (M) SDN510(k) NO: K000217(TRADITIONAL)
ATTN: JANNA P TUCKER              PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD        SE DECISION MADE: 18-FEB-00
SPARKS, NV 89434-9550             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES
SHIJIAZHUANG GREAT EAGLE PLASTIC P510(k) NO: K000166(TRADITIONAL)
ATTN: JAMES  CHU                  PHONE NO : 909-548-4828
13945 MAGNOLIA AVENUE             SE DECISION MADE: 22-FEB-00
CHINO, CA 91710                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES
SHIJIAZHUANG HONGRAY PLASTIC PRODU510(k) NO: K994206(TRADITIONAL)
ATTN: GUI-XI  LIU                 PHONE NO : 011 863 113613127
NO. 135 XIN-HUA WEST ROAD         SE DECISION MADE: 07-FEB-00
SHIJIAZHUANG CITY                 510(k) STATEMENT
HEBEI PROVINCE, CHINA 050081

DEVICE: SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLO
SHIJIAZHUANG HONGRAY PLASTIC PRODU510(k) NO: K994222(TRADITIONAL)
ATTN: GUI-XI  LIU                 PHONE NO : 011 863 113613127
NO. 135 XIN-HUA WEST RD.          SE DECISION MADE: 07-FEB-00
SHIJIAZHUANG, CHINA 050081        510(k) STATEMENT

DEVICE: PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSUL
SHIN CHANG MEDICAL CO., LTD.      510(k) NO: K993017(TRADITIONAL)
ATTN: JAN J FRANK                 PHONE NO : 801-263-0975
3762 SOUTH 150 EAST               SE DECISION MADE: 25-FEB-00
SALT LAKE CITY, UT 84115          510(k) STATEMENT

DEVICE: SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR
SIEMENS MEDICAL SYSTEMS, INC.     510(k) NO: K993974(TRADITIONAL)
ATTN: PENELOPE H GRECO            PHONE NO : 978-907-7500
16 ELECTRONICS AVE.               SE DECISION MADE: 22-FEB-00
DANVERS, MA 01923                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM
SIEMENS MEDICAL SYSTEMS, INC.     510(k) NO: K994315(TRADITIONAL)
ATTN: JAMIE  YIEH                 PHONE NO : 732-321-4625
186 WOOD AVENUE SOUTH             SE DECISION MADE: 04-FEB-00
ISELIN, NJ 08830                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIMS PORTEX ANESTHESIA CATHETER
SIMS PORTEX, INC.                 510(k) NO: K994275(TRADITIONAL)
ATTN: TIMOTHY J TALCOTT           PHONE NO : 603-352-3812
10 BOWMAN DR.                     SE DECISION MADE: 22-FEB-00
KEENE, NH 03431                   510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: CEREC 3
SIRONA DENTAL SYSTEMS GMBH        510(k) NO: K994172(SPECIAL)
ATTN: SHEILA  HEMEON-HEYER        PHONE NO : 508-643-0434
49 PLAIN STREET                   SE DECISION MADE: 08-FEB-00
NORTH ATTLEBORO, MA 02760         510(k) STATEMENT

DEVICE: SD-730 IF-SDS, PERFECT PULSE IF-SDS
SKYLARK DEVICE & SYSTEMS CO., LTD 510(k) NO: K992652(TRADITIONAL)
ATTN: GEORGE K.C.  CHEN           PHONE NO : 011 886 225979005
34 CHUNG SHAN NORTH RD.,          SE DECISION MADE: 03-FEB-00
12TH FL., SEC. 3                  510(k) STATEMENT
TAIPEI, CHINA (TAIWAN)

DEVICE: CAP PORP, CAP TORP
SMITH & NEPHEW ENT.               510(k) NO: K000256(TRADITIONAL)
ATTN: ALICIA  FARAGE              PHONE NO : 901-373-0279
2925 APPLING RD.                  SE DECISION MADE: 11-FEB-00
BARTLETT, TN 38133                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RADIAL HEAD PROSTHESIS
SMITH & NEPHEW, INC.              510(k) NO: K992220(ABBREVIATED)
ATTN: JANET  JOHNSON GREEN        PHONE NO : 901-396-2121
1450 E. BROOKS ROAD               SE DECISION MADE: 25-FEB-00
MEMPHIS, TN 38116                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & M
SMITH & NEPHEW, INC.              510(k) NO: K994143(TRADITIONAL)
ATTN: DAVID  HENLEY               PHONE NO : 901-399-6487
1450 E. BROOKS ROAD               SE DECISION MADE: 18-FEB-00
MEMPHIS, TN 38116                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX
SMITH & NEPHEW, INC.              510(k) NO: K994202(TRADITIONAL)
ATTN: NICHOLAS  CONDAKES          PHONE NO : 508-261-3770
130 FORBES BLVD.                  SE DECISION MADE: 25-FEB-00
MANSFIELD, MA 02048               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SNAP MODEL 5
SNAP LABORATORIES, L.L.C.         510(k) NO: K992322(TRADITIONAL)
ATTN: GIL  RAVIV                  PHONE NO : 847-657-8100
3633 WEST LAKE AVE., SUITE 406    SE DECISION MADE: 02-FEB-00
GLENVIEW, IL 60025                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY
SPECIALTY ULTRAVISION, INC.       510(k) NO: K992787(TRADITIONAL)
ATTN: IVALEE I COHEN              PHONE NO : 408-341-0700
307 ORCHARD CITY DRIVE            SE DECISION MADE: 02-FEB-00
SUITE 100                         510(k) SUMMARY AVAILABLE FROM FDA
CAMPBELL, CA 95008

DEVICE: SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES F
SPECIALTY ULTRAVISION, INC.       510(k) NO: K993580(TRADITIONAL)
ATTN: RICHARD  LIPPMAN            PHONE NO : 408-341-0700
307 ORCHARD CITY DRIVE            SE DECISION MADE: 02-FEB-00
SUITE 100                         510(k) SUMMARY AVAILABLE FROM FDA
CAMPBELL, CA 95008

 
DEVICE: BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
SPECTRX, INC.                     510(k) NO: K994438(TRADITIONAL)
ATTN: JAMES R VEALE               PHONE NO : 508-643-0434
49 PLAIN STREET                   SE DECISION MADE: 04-FEB-00
NORTH ATTLEBORO, MA 02760         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL
ST. GEORGE TECHNOLOGY, INC.       510(k) NO: K992176(TRADITIONAL)
ATTN: VERNON  WATKINS             PHONE NO : 910-397-0781
P.O. BOX 2849                     SE DECISION MADE: 10-FEB-00
WILMINGTON, NC 28402-2849         510(k) STATEMENT

DEVICE: SJM TAILOR ANNULOPLASTY RING, MODEL TARN
ST. JUDE MEDICAL, INC.            510(k) NO: K000119(SPECIAL)
ATTN: WILLIAM  MCKELVEY           PHONE NO : 651-415-7029
ONE LILLEHEI PLAZA                SE DECISION MADE: 17-FEB-00
ST. PAUL, MN 55117                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ONEFLOW
STI MEDICAL                       510(k) NO: K980951(TRADITIONAL)
ATTN: LAUREN R ZIEGLER            PHONE NO : 973-857-3414
908 POMPTON AVE.                  SE DECISION MADE: 25-FEB-00
CEDAR GROVE, NJ 07009             510(k) STATEMENT

DEVICE: CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION
STRIETER CLINICAL RESEARCH LABORAT510(k) NO: K994021(TRADITIONAL)
ATTN: JAMES F STRIETER            PHONE NO : 800-851-4557
222 VANDALIA STREET               SE DECISION MADE: 22-FEB-00
COLLINSVILLE, IL 62234            510(k) STATEMENT

DEVICE: LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM
STRYKER INSTRUMENTS               510(k) NO: K993990(TRADITIONAL)
ATTN: KRISTYN R KELLEY            PHONE NO : 800-253-7370
4100 EAST MILHAM AVE.             SE DECISION MADE: 22-FEB-00
KALAMAZOO, MI 49001               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL
SURGICAL INSTRUMENT SYSTEMS (SIS),510(k) NO: K993190(TRADITIONAL)
ATTN: JUDY  GORDON                PHONE NO : 949-854-6314
18732 SAGINAW                     SE DECISION MADE: 10-FEB-00
IRVINE, CA 92612                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATI
SURGICAL NAVIGATION SPECIALISTS IN510(k) NO: K994421(TRADITIONAL)
ATTN: CAROL  NAKAGAWA             PHONE NO : 905 672 2100
6509 AIRPORT RD.                  SE DECISION MADE: 23-FEB-00
MISSISSAUGA, ONTARIO, CANADA L4V 1510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STEALTHSTATION TREATMENT GUIDANCE PLATFORM
SURGICAL NAVIGATION TECHNOLOGIES, 510(k) NO: K992461(TRADITIONAL)
ATTN: ROGER N WHITE               PHONE NO : 303-439-9709
530 COMPTON ST.                   SE DECISION MADE: 22-FEB-00
BROOMFIELD, CO 80020              510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: SUTRALON NYLON SUTURES
SUTRATEC, INC.                    510(k) NO: K994176(TRADITIONAL)
ATTN: JONATHAN  GREEN             PHONE NO : 202-966-3790
4740 CONNECTICUT AVE. N.W.        SE DECISION MADE: 08-FEB-00
SUITE 708                         510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20008

DEVICE: SUTRASILK SILK SUTURE
SUTRATEC, INC.                    510(k) NO: K994177(TRADITIONAL)
ATTN: JONATHAN  GREEN             PHONE NO : 202-966-3790
4740 CONNECTICUT AVE. N.W.        SE DECISION MADE: 08-FEB-00
SUITE 708                         510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20008

DEVICE: SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
SYNTHES (USA)                     510(k) NO: K000089(TRADITIONAL)
ATTN: BONNIE J SMITH              PHONE NO : 610-647-9700
1690 RUSSELL ROAD                 SE DECISION MADE: 03-FEB-00
PAOLI, PA 19301                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLICK'X
SYNTHES SPINE                     510(k) NO: K992739(TRADITIONAL)
ATTN: JONATHAN M GILBERT          PHONE NO : 610-647-9700
P.O. BOX 0548                     SE DECISION MADE: 08-FEB-00
1690 RUSSELL ROAD                 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301

DEVICE: SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
SYVA CO.                          510(k) NO: K993980(TRADITIONAL)
ATTN: PAUL L ROGERS               PHONE NO : 408-239-2309
3403 YERBA BUENA RD.              SE DECISION MADE: 01-FEB-00
SAN JOSE, CA 95161-9013           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
SYVA CO.                          510(k) NO: K993981(TRADITIONAL)
ATTN: PAUL L ROGERS               PHONE NO : 408-239-2309
3403 YERBA BUENA RD.              SE DECISION MADE: 01-FEB-00
SAN JOSE, CA 95161-9013           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200,
TANDEM MEDICAL, INC.              510(k) NO: K993832(TRADITIONAL)
ATTN: ALBERT  MISAJON             PHONE NO : 858-673-3900
15910 BERNARDO CENTER DR.         SE DECISION MADE: 09-FEB-00
SAN DIEGO, CA 92127               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXTENDED STRAIGHT ATTACHMENT
TEAM TECHNOLOGIES, INC.           510(k) NO: K994024(TRADITIONAL)
ATTN: BOB  WALTON                 PHONE NO : 423-587-2199
5949 COMMERCE BLVD.               SE DECISION MADE: 03-FEB-00
MORRISTOWN, TN 37814              510(k) STATEMENT

DEVICE: GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
TECO DIAGNOSTICS                  510(k) NO: K000102(SPECIAL)
ATTN: DINDO  CARRILLO             PHONE NO : 714-693-7788
4925 EAST HUNTER AVE.             SE DECISION MADE: 08-FEB-00
ANAHEIM, CA 92807                 510(k) STATEMENT

 
DEVICE: TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTE
TEKMEDIC (M) SDN BHD              510(k) NO: K994250(TRADITIONAL)
ATTN: KOK-KEE  HON                PHONE NO : 703-941-7576
6324 MEETING HOUSE WAY            SE DECISION MADE: 07-FEB-00
ALEXANDRIA, VA 22312-1718         510(k) STATEMENT

DEVICE: TED 200T7 OXYGEN MONITOR
TELEDYNE ELECTRONIC TECHNOLOGIES  510(k) NO: K990403(TRADITIONAL)
ATTN: RAY  KHAJAVI                PHONE NO : 626-934-1502
16830 CHESTNUT STREET             SE DECISION MADE: 03-FEB-00
CITY OF INDUSTRY, CA              510(k) STATEMENT

DEVICE: ILM ENDOTRACHEAL TUBE
THE LARYNGEAL MASK CO.,LTD.       510(k) NO: K991580(TRADITIONAL)
ATTN: ROBERT GAINES  COOPER       PHONE NO : 001 357 2670000
12300 TWINBROOK PARKWAY           SE DECISION MADE: 04-FEB-00
ROCKVILLE, MD 20852               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/S
THE PROMETHEUS GROUP              510(k) NO: K993976(TRADITIONAL)
ATTN: RICHARD  HORTON             PHONE NO : 781-582-2328
2 MALLARDS COVE                   SE DECISION MADE: 22-FEB-00
DUXBURY, MA 02332                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DOGBONE ACFS
THEKEN SURGICAL                   510(k) NO: K994383(TRADITIONAL)
ATTN: LUKAS  EISERMANN            PHONE NO : 330-753-7451
1100 NOLA AVENUE                  SE DECISION MADE: 04-FEB-00
BARBERTON, OH 44203               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERMACOL
TISSUE SCIENCE LABORATORIES, PLC  510(k) NO: K992556(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN           PHONE NO : 202-637-5600
7124 LA JOLLA BLVD.               SE DECISION MADE: 17-FEB-00
LA JOLLA, CA                      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TMC-EASY-302
TMC MAGNETICS & MACHINERY CORP.   510(k) NO: K984565(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 203-431-1511
55 NORTHERN BLVD.                 SE DECISION MADE: 16-FEB-00
GREAT NECK, NY 11021              510(k) STATEMENT

DEVICE: TOKUYAMA ONE-UP-BOND F
TOKUYAMA AMERICA, INC.            510(k) NO: K993917(TRADITIONAL)
ATTN: DANIEL J MANELLI            PHONE NO : 202-261-1000
2000 M STREET NW                  SE DECISION MADE: 02-FEB-00
SUITE 700                         510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20036

 
DEVICE: EXCELART WITH PIANISSIMO
TOSHIBA AMERICA MRI, INC.         510(k) NO: K993803(TRADITIONAL)
ATTN: KEN  NEHMER                 PHONE NO : 650-872-2722
280 UTAH AVE.                     SE DECISION MADE: 06-FEB-00
SOUTH SAN FRANCISCO, CA 94080-6883510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLYPROPYLENE
TRADING CONSULTANTS AND DISTRIBUTO510(k) NO: K993997(TRADITIONAL)
ATTN: MAIN M GHAZAL               PHONE NO : 847-265-7676
157 WINDDANCE DR.                 SE DECISION MADE: 04-FEB-00
CHICAGO, IL 60046                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NYLON
TRADING CONSULTANTS AND DISTRIBUTO510(k) NO: K993998(TRADITIONAL)
ATTN: MAIN M GHAZAL               PHONE NO : 847-265-7676
157 WINDDANCE DR.                 SE DECISION MADE: 04-FEB-00
CHICAGO, IL 60046                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SILK
TRADING CONSULTANTS AND DISTRIBUTO510(k) NO: K993999(TRADITIONAL)
ATTN: MAIN M GHAZAL               PHONE NO : 847-265-7676
157 WINDDANCE DR.                 SE DECISION MADE: 04-FEB-00
CHICAGO, IL 60046                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLYESTER
TRADING CONSULTANTS AND DISTRIBUTO510(k) NO: K994000(TRADITIONAL)
ATTN: MAIN M GHAZAL               PHONE NO : 847-265-7676
157 WINDDANCE DR.                 SE DECISION MADE: 04-FEB-00
CHICAGO, IL 60046                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLYGLYCOLIC ACID
TRADING CONSULTANTS AND DISTRIBUTO510(k) NO: K994001(TRADITIONAL)
ATTN: MAIN M GHAZAL               PHONE NO : 847-265-7676
157 WINDDANCE DR.                 SE DECISION MADE: 09-FEB-00
CHICAGO, IL 60046                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLAIN/CHROMIC CATGUT
TRADING CONSULTANTS AND DISTRIBUTO510(k) NO: K994002(TRADITIONAL)
ATTN: MAIN M GHAZAL               PHONE NO : 847-265-7676
157 WINDDANCE DR.                 SE DECISION MADE: 04-FEB-00
CHICAGO, IL 60046                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E.N.S.I. SYRINGE
TRI-JECT INTL. CORP.              510(k) NO: K000572(TRADITIONAL)
ATTN: PETER G LEMIN               PHONE NO : 253-845-8400
310 MERIDIAN N., SUITE 6          SE DECISION MADE: 24-FEB-00
PUYALLUP, WA 98371                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVABONE-BIOGLASS BONE GRAFT PARTICULATE
U.S. BIOMATERIALS CORP.           510(k) NO: K000149(SPECIAL)
ATTN: ALBERT  FOSMOE              PHONE NO : 904-462-7660
ONE PROGRESS BLVD. #23            SE DECISION MADE: 07-FEB-00
ALACHUA, FL 32615                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: ULTRASEAL XT PLUS
ULTRADENT PRODUCTS, INC.          510(k) NO: K993846(TRADITIONAL)
ATTN: SCOTT E MOORE               PHONE NO : 801-572-4200
505 WEST 10200 SOUTH              SE DECISION MADE: 16-FEB-00
SOUTH JORDAN, UT 84095            510(k) STATEMENT

DEVICE: ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT
ULTRADENT PRODUCTS, INC.          510(k) NO: K994261(TRADITIONAL)
ATTN: SCOTT E MOORE               PHONE NO : 800-552-5512
505 WEST 10200 SOUTH              SE DECISION MADE: 02-FEB-00
SOUTH JORDAN, UT 84095            510(k) STATEMENT

DEVICE: CAVERMAP SURGICAL AID
UROMED CORP.                      510(k) NO: K993436(TRADITIONAL)
ATTN: FREDERICK  TOBIA            PHONE NO : 781-762-2080
1400 PROVIDENCE HWY., BLDG.2      SE DECISION MADE: 11-FEB-00
NORWOOD, MA 02062                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGNA 5000 PHASED ARRAY CTL SPINE COIL
USA INSTRUMENTS, INC.             510(k) NO: K000002(TRADITIONAL)
ATTN: RONY  THOMAS                PHONE NO : 330-562-1000
1515 DANNER DRIVE                 SE DECISION MADE: 23-FEB-00
AURORA, OH 44202                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGNA 5000 PHASED ARRAY CTL SPINE COIL
USA INSTRUMENTS, INC.             510(k) NO: K994345(TRADITIONAL)
ATTN: RONY  THOMAS                PHONE NO : 330-562-1000
1515 DANNER DRIVE                 SE DECISION MADE: 14-FEB-00
AURORA, OH 44202                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISSA PHAROS
VAMS TEC, D.O.O.                  510(k) NO: K994054(TRADITIONAL)
ATTN: DAVID W SCHLERF             PHONE NO : 925-356-2640
200 GREGORY LANE                  SE DECISION MADE: 14-FEB-00
SUITE C-100                       510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389

DEVICE: VANNA BATHING SYSTEM
VANCARE, INC.                     510(k) NO: K993872(TRADITIONAL)
ATTN: JAMES A VANDERHEIDEN        PHONE NO : 402-694-4525
1515 1ST ST.                      SE DECISION MADE: 16-FEB-00
AURORA, NE 68818                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOMAVISION
VARIAN ASSOC., INC.               510(k) NO: K992751(TRADITIONAL)
ATTN: LINDA S NASH                PHONE NO : 650-424-6990
3045 HANOVER STREET               SE DECISION MADE: 16-FEB-00
PALO ALTO, CA 94304               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VEIN ENTRY INDICATOR DEVICE (VEID)
VASCULAR TECHNOLOGIES LTD.        510(k) NO: K993995(TRADITIONAL)
ATTN: AHAVA  STEIN                PHONE NO : 972 979 20673
P.O.B. 454                        SE DECISION MADE: 14-FEB-00
GINOT SHOMRON, ISRAEL 44853       510(k) STATEMENT

 
DEVICE: LEMAITRE BALLOON CATHETER WITH IRRIGATION
VASCUTECH, INC.                   510(k) NO: K992940(TRADITIONAL)
ATTN: TRENT G KAMKE               PHONE NO : 781-221-2266
164 MIDDLESEX TURNPIKE            SE DECISION MADE: 22-FEB-00
BURLINGTON, MA 01803              510(k) STATEMENT

DEVICE: VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND V
VISTAKON, JOHNSON & JOHNSON VISION510(k) NO: K994318(TRADITIONAL)
ATTN: SHARON  BRIGGS              PHONE NO : 904-443-1471
7500 CENTURION PKWY.              SE DECISION MADE: 23-FEB-00
JACKSONVILLE, FL 32256            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND V
VISTAKON, JOHNSON & JOHNSON VISION510(k) NO: K994324(TRADITIONAL)
ATTN: SHARON  BRIGGS              PHONE NO : 904-443-1471
7500 CENTURION PKWY.              SE DECISION MADE: 23-FEB-00
JACKSONVILLE, FL 32256            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEEN-ABLE
VITAL SIGNS, INC.                 510(k) NO: K994044(TRADITIONAL)
ATTN: ANTHONY  MARTINO            PHONE NO : 973-790-1330
20 CAMPUS RD.                     SE DECISION MADE: 25-FEB-00
TOTOWA, NJ 07512                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITALOGRAPH MICRO
VITALOGRAPH INC.                  510(k) NO: K991412(TRADITIONAL)
ATTN: PHIL  HEMES                 PHONE NO : 913-888-4221
8347 QUIVIRA RD.                  SE DECISION MADE: 04-FEB-00
LENEXA, KS 66215                  510(k) STATEMENT

DEVICE: ASP-100, MODEL 2100
VITROLIFE AB                      510(k) NO: K991345(TRADITIONAL)
ATTN: GRAY L YINGLING             PHONE NO : 202-496-7645
MOLNDALSVAGEN 30                  SE DECISION MADE: 18-FEB-00
GOTHENBURG, SWEDEN SE-412 63      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PH-100, MODEL 2104
VITROLIFE AB                      510(k) NO: K991346(TRADITIONAL)
ATTN: GARY L YINGLING             PHONE NO : 202-496-7645
MOLNDALSVAGEN 30                  SE DECISION MADE: 24-FEB-00
GOTHENBURG, SWEDEN SE-412 63      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OVOIL-150, MODEL 5002
VITROLIFE AB                      510(k) NO: K991351(TRADITIONAL)
ATTN: GARY L YINGLING             PHONE NO : 202-496-7500
MOLNDALSVAGEN 30                  SE DECISION MADE: 25-FEB-00
GOTHENBURG, SWEDEN SE-412 63      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARABESK TOP
VOCO GMBH                         510(k) NO: K994268(TRADITIONAL)
ATTN: EVAN  DICK                  PHONE NO : 314-721-0112
7527 WESTMORELAND AVE.            SE DECISION MADE: 03-FEB-00
ST. LOUIS, MO 63105               510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: ARABESK FLOW
VOCO GMBH                         510(k) NO: K994304(TRADITIONAL)
ATTN: EVAN  DICK                  PHONE NO : 314-721-0112
7527 WESTMORELAND AVE.            SE DECISION MADE: 07-FEB-00
ST. LOUIS, MO 63105               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
W.L. GORE & ASSOCIATES,INC        510(k) NO: K000185(SPECIAL)
ATTN: R. LARRY  PRATT             PHONE NO : 520-779-2771
3450 WEST KILTIE LANE             SE DECISION MADE: 14-FEB-00
P.O. BOX 500                      510(k) SUMMARY AVAILABLE FROM FDA
FLAGSTAFF, AZ 86002-0500

DEVICE: WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1
WHITESIDE BIOMECHANICS, INC.      510(k) NO: K993903(TRADITIONAL)
ATTN: DEBRA  MEYER                PHONE NO : 314-996-8540
12634 OLIVE BLVD.                 SE DECISION MADE: 14-FEB-00
ST. LOUIS, MO 63141               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHRO-SURGIMAT-A103
WOM GMBH                          510(k) NO: K000153(SPECIAL)
ATTN: MICHAEL  MCGRAIL            PHONE NO : 508-337-2188
194 BRANCH ST                     SE DECISION MADE: 08-FEB-00
MANSFIELD, MA 02048               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOCON-T DISTAL RADIAL PLATE
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K994061(TRADITIONAL)
ATTN: LYNNE  WITKOWSKI            PHONE NO : 901-867-4620
5677 AIRLINE RD.                  SE DECISION MADE: 14-FEB-00
ARLINGTON, TN 38002               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IDX-60 INTRAORAL X-RAY
X-CEL X-RAY CORP.                 510(k) NO: K993958(TRADITIONAL)
ATTN: WILLIAM W MORRIS            PHONE NO : 815-455-2470
4220 WALLER DR., P.O. BOX 1857    SE DECISION MADE: 14-FEB-00
CRYSTAL LAKE, IL 60039-1857       510(k) STATEMENT

DEVICE: FRONTAL SINUS TREPHINATION CANNULA
XOMED, INC.                       510(k) NO: K994262(TRADITIONAL)
ATTN: MARTIN D SARGENT            PHONE NO : 904-279-7586
6743 SOUTHPOINT DR. NORTH         SE DECISION MADE: 08-FEB-00
JACKSONVILLE, FL 32216            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM
ZEUS SCIENTIFIC, INC.             510(k) NO: K000362(SPECIAL)
ATTN: MARK J KOPNITSKY            PHONE NO : 908-526-3744
P.O. BOX 38                       SE DECISION MADE: 18-FEB-00
RARITAN, NJ 08869                 510(k) STATEMENT

DEVICE: MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA T
ZEUS SCIENTIFIC, INC.             510(k) NO: K000363(SPECIAL)
ATTN: MARK J KOPNITSKY            PHONE NO : 908-526-3744
P.O. BOX 38                       SE DECISION MADE: 18-FEB-00
RARITAN, NJ 08869                 510(k) STATEMENT

DEVICE: ZOLL M SERIES ETCO2 OPTION
ZOLL MEDICAL CORP.                510(k) NO: K993036(TRADITIONAL)
ATTN: PAUL  DIAS                  PHONE NO : 781-229-0020
32 SECOND AVE.                    SE DECISION MADE: 28-FEB-00
BURLINGTON, MA 01803              510(k) STATEMENT


 
                                                TOTAL 510(k)s THIS PERIOD   313
                                                TOTAL WITH SUMMARIES        223
                                                TOTAL WITH STATEMENTS        90
Updated 5/22/2000
horizonal rule
Center for Devices and Radiological Health / CDRH