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June 1999 510(k) Clearances

DEVICE: AST/SGOT
A.P. TOTAL CARE, INC.             510(k) NO: K991663(TRADITIONAL)
ATTN: LUIS P LEON                 PHONE NO : 203-335-9277
70 HAWLEY AVE,                    SE DECISION MADE: 30-JUN-99
PO BOX 6216                       510(k) STATEMENT
BRIDGEPORT, CT

DEVICE: TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
A.P. TOTAL CARE, INC.             510(k) NO: K991666(TRADITIONAL)
ATTN: LUIS P LEON                 PHONE NO : 203-335-9277
70 HAWLEY AVE,                    SE DECISION MADE: 30-JUN-99
PO BOX 6216                       510(k) STATEMENT
BRIDGEPORT, CT

DEVICE: HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM
ABATEMENT TECHNOLOGIES, INC.      510(k) NO: K984116(TRADITIONAL)
ATTN: DAVID  WILLYARD             PHONE NO : 770-339-2600
2220 NORTHMONT PKWY.,             SE DECISION MADE: 24-JUN-99
SUITE 100                         510(k) STATEMENT
DULUTH, GA

DEVICE: CELL-DYN 1200 SYSTEM
ABBOTT LABORATORIES, INC.         510(k) NO: K991142(ABBREVIATED)
ATTN: JANICE E BROWN              PHONE NO : 408-567-3521
5440 PATRICK HENRY DR.            SE DECISION MADE: 23-JUN-99
SANTA CLARA, CA 95054             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRP
ABBOTT LABORATORIES, INC.         510(k) NO: K991372(TRADITIONAL)
ATTN: LINDA  MORRIS               PHONE NO : 972-518-6711
1920 HURD                         SE DECISION MADE: 01-JUN-99
IRVING, TX 75062                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE ACME MEDICAL AESTHETIC ND:YAG LASER
ACME MEDICAL, INC.                510(k) NO: K991234(TRADITIONAL)
ATTN: MIKE  LEVERNIER             PHONE NO : 650-372-1332
1181 CHESS DRIVE, SUITE B         SE DECISION MADE: 28-JUN-99
FOSTER CITY, CA 94404             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA
ADVANCED MEDICAL SOLUTIONS GROUP P510(k) NO: K991287(TRADITIONAL)
ATTN: CHRISTOPHER  OAKES          PHONE NO : 011 441 606863500
ROAD THREE,                       SE DECISION MADE: 29-JUN-99
WINFORD INDUSTRIAL ESTATE         510(k) SUMMARY AVAILABLE FROM FDA
WINSFORD, CHESHIRE, UNITED KINGDOM CW7 3PD

DEVICE: ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET
ADVANCED MEDICAL SOLUTIONS GROUP P510(k) NO: K991630(TRADITIONAL)
ATTN: CHRIS  OAKES                PHONE NO : 011 441 606863500
ROAD THREE,                       SE DECISION MADE: 11-JUN-99
WINFORD INDUSTRIAL ESTATE         510(k) SUMMARY AVAILABLE FROM FDA
WINSFORD, CHESHIRE, UNITED KINGDOM CW7 3PD

DEVICE: LAMITRODE LEADS
ADVANCED NEUROMODULATION SYSTEMS, 510(k) NO: K990469(TRADITIONAL)
ATTN: DREW  JOHNSON               PHONE NO : 972-390-9800
ONE ALLENTOWN PKWY.               SE DECISION MADE: 03-JUN-99
ALLEN, TX 75002-4211              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENEW LEAD EXTENSION
ADVANCED NEUROMODULATION SYSTEMS, 510(k) NO: K991784(SPECIAL)
ATTN: KATRYNA  WARREN             PHONE NO : 972-390-9800
ONE ALLENTOWN PKWY.               SE DECISION MADE: 24-JUN-99
ALLEN, TX 75002-4211              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION OF: STERRAD BI TEST PACK
ADVANCED STERILIZATION PRODUCTS   510(k) NO: K991675(SPECIAL)
ATTN: KEVIN  CORRIGAN             PHONE NO : 949-453-6410
33 TECHNOLOGY DR.                 SE DECISION MADE: 15-JUN-99
IRVINE, CA 92718                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
ADVANCED TECHNOLOGY LABORATORIES, 510(k) NO: K991671(TRADITIONAL)
ATTN: TERRENCE J SWEENEY          PHONE NO : 425-487-7602
22100 BOTHELL EVERETT HWY.        SE DECISION MADE: 18-JUN-99
P.O. BOX 3003                     510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-3003

DEVICE: AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER
AKTINA MEDICAL PHYSICS CORP.      510(k) NO: K990997(TRADITIONAL)
ATTN: JOAN Z ACHAROPOULOS         PHONE NO : 914-268-0101
360 NORTH ROUTE 9W                SE DECISION MADE: 22-JUN-99
CONGERS, NY 10920                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BROWNE MVI ETHYLENE OXIDE INDICATOR
ALBERT BROWNE LTD.                510(k) NO: K991418(ABBREVIATED)
ATTN: CYNTHIA J.M.  NOLTE         PHONE NO : 919-859-4207
49 PLAIN STREET                   SE DECISION MADE: 10-JUN-99
NORTH ATTLEBORO, MA 02760         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS
ALLEGIANCE HEALTHCARE CORP.       510(k) NO: K991928(SPECIAL)
ATTN: PATRICIA  SHARPE-GREGG      PHONE NO : 847-578-3636
1500 WAUKEGAN RD.                 SE DECISION MADE: 25-JUN-99
WILLIAM MERZ BUILDING             510(k) SUMMARY AVAILABLE FROM FDA
MCGAW PARK, IL 60085

DEVICE: AMIB7
ALLIANCE MEDICAL, INC.            510(k) NO: K990198(TRADITIONAL)
ATTN: JAMES  RIEDL                PHONE NO : 514 344 3030
7800 COTE DE LIESSE               SE DECISION MADE: 29-JUN-99
ST. LAURENT, QUEBEC, CANADA H4T 1G510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALPHAMED GEMINI SENSOR, SNORING SENSOR
ALPHAMED, INC.                    510(k) NO: K990321(TRADITIONAL)
ATTN: PETER  STASE                PHONE NO : 612-789-8200
3989 CENTRAL AVE. NE              SE DECISION MADE: 01-JUN-99
SUITE 560                         510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55421

DEVICE: MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL
AMERICAN BIO MEDICA CORP.         510(k) NO: K992033(TRADITIONAL)
ATTN: JOHN B DUBECK               PHONE NO : 202-434-4125
1001 G STREET, NW                 SE DECISION MADE: 30-JUN-99
SUITE 500W                        510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20001

DEVICE: AMERICAN DENTAL PRODUCTS ETCH-DETECT
AMERICAN DENTAL PRODUCTS, INC.    510(k) NO: K991099(TRADITIONAL)
ATTN: GEORGE  NICOLAE             PHONE NO : 630-238-0275
603-B COUNTRY CLUB DR.            SE DECISION MADE: 10-JUN-99
BENSENVILLE, IL 60106-1329        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COAGULOOP
AMERICAN MEDICAL SYSTEMS, INC.    510(k) NO: K991314(TRADITIONAL)
ATTN: DAVID  WORRELL              PHONE NO : 612-933-4666
10700 BREN RD., WEST              SE DECISION MADE: 29-JUN-99
MINNETONKA, MN 55343              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMIGO MODEL 590000
AMIGO MOBILITY INTL., INC.        510(k) NO: K983987(TRADITIONAL)
ATTN: DALE  CONFER                PHONE NO : 517-777-0910
6693 DIXIE HIGHWAY                SE DECISION MADE: 08-JUN-99
BRIDGEPORT, MI 48722              510(k) STATEMENT

DEVICE: SOFTINJECT
ANDROSYSTEMS SRL                  510(k) NO: K991680(TRADITIONAL)
ATTN: MARIA E DONAWA              PHONE NO : 390 657 82665
VIALE LIEGI, 12                   SE DECISION MADE: 03-JUN-99
ROME, ITALY 00198                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM
ANGIODYNAMICS, INC.               510(k) NO: K991793(SPECIAL)
ATTN: TERI  JUCKETT               PHONE NO : 518-798-1215
603 QUEENSBURY AVE.               SE DECISION MADE: 25-JUN-99
QUEENSBURY, NY 12804              510(k) STATEMENT

DEVICE: C-FLEX URETERAL STENTS
APPLIED MEDICAL RESOURCES         510(k) NO: K991219(TRADITIONAL)
ATTN: ANIL  BHALANI               PHONE NO : 949-582-6120
26051 MERIT CIRCLE, #104          SE DECISION MADE: 21-JUN-99
LAGUNA HILLS, CA 92653            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAI
ARISTA LATINDO INDUSTRIAL, LTD. P.510(k) NO: K991686(TRADITIONAL)
ATTN: LINGA  SUMARTA              PHONE NO : 622 166 20201/195
128 JALAN KYAI HAJI MUHAMMAD      SE DECISION MADE: 11-JUN-99
MANSYUR                           510(k) STATEMENT
JAKARTA BARAT, INDONESIA 11210

DEVICE: ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO)
ASTRA TECH, INC.                  510(k) NO: K991053(TRADITIONAL)
ATTN: NIKLAS  LIDSKOG             PHONE NO : 781-861-7707
430 BEDFORD STREET                SE DECISION MADE: 25-JUN-99
SUITE 100                         510(k) SUMMARY AVAILABLE FROM FDA
LEXINGTON, MA 02420

DEVICE: UNI-GRAFT K DV VASCULAR GRAFT
ATRIUM MEDICAL CORP.              510(k) NO: K991813(TRADITIONAL)
ATTN: JOE  DE PAOLO               PHONE NO : 603-880-1433
5 WENTWORTH DR.                   SE DECISION MADE: 01-JUN-99
HUDSON, NH 03051                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVOGEL
AVOCET POLYMER TECHNOLOGIES, INC. 510(k) NO: K981353(TRADITIONAL)
ATTN: MARY  CAPELLI-SCHELLPFEFFER PHONE NO : 205-533-4201
2305 SPRING BRANCH RD.            SE DECISION MADE: 01-JUN-99
HUNTSVILLE, AL 35801              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPACT BALLOON DILATION CATHETER
B. BRAUN/MCGAW                    510(k) NO: K983373(TRADITIONAL)
ATTN: MARK S ALSBERGE             PHONE NO : 610-997-4360
824 12TH AVENUE                   SE DECISION MADE: 22-JUN-99
BETHLEHEM, PA 18018-0027          510(k) STATEMENT

DEVICE: RENAL LINK
BAXTER HEALTHCARE CORP.           510(k) NO: K990953(TRADITIONAL)
ATTN: DAVID E CURTIN              PHONE NO : 847-473-6079
1620 WAUKEGAN ROAD                SE DECISION MADE: 18-JUN-99
MCGAW PARK, IL 60085              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA
BAXTER RESEARCH MEDICAL, INC.     510(k) NO: K983791(TRADITIONAL)
ATTN: JOHN W SMITH                PHONE NO : 801-565-6213
6864 SOUTH 300 WEST               SE DECISION MADE: 11-JUN-99
MIDVALE, UT 84047                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLUCOMETER ELITE TEST STRIPS
BAYER CORP.                       510(k) NO: K991242(TRADITIONAL)
ATTN: GEORGE M TANCOS             PHONE NO : 219-262-6928
1884 MILES AVE.                   SE DECISION MADE: 30-JUN-99
ELKHART, IN 46515-2004            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
BAYER CORP.                       510(k) NO: K991576(TRADITIONAL)
ATTN: GABRIEL J MURACA            PHONE NO : 914-524-3494
511 BENEDICT AVE.                 SE DECISION MADE: 30-JUN-99
TARRYTOWN, NY 10591-5097          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPNOCHECK II, MODEL 8400
BCI INTL., INC.                   510(k) NO: K991086(TRADITIONAL)
ATTN: DONALD  ALEXANDER           PHONE NO : 414-542-3100
N7 W22025 JOHNSON ROAD            SE DECISION MADE: 09-JUN-99
WAUKESHA, WI 53186                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3402 HANDHELD PULSE OXIMETER
BCI INTL., INC.                   510(k) NO: K991410(TRADITIONAL)
ATTN: DONALD  ALEXANDER           PHONE NO : 414-542-3100
N7 W22025 JOHNSON ROAD            SE DECISION MADE: 09-JUN-99
WAUKESHA, WI 53186                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNO
BECKMAN                           510(k) NO: K991707(SPECIAL)
ATTN: ANGELA  BYLAND              PHONE NO : 612-368-1615
1000 LAKE HAZELTINE DR.           SE DECISION MADE: 01-JUN-99
CHASKA, MN 55318                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VARIANT II B-THALASSEMIA
BIO-RAD LABORATORIES, INC.        510(k) NO: K991127(SPECIAL)
ATTN: JULIET  CARRARA             PHONE NO : 510-741-6188
4000 ALFRED NOBEL DR.             SE DECISION MADE: 10-JUN-99
HERCULES, CA 94547                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATA
BIOCHECK, INC.                    510(k) NO: K990993(TRADITIONAL)
ATTN: ROBIN  HELLEN               PHONE NO : 818-709-5646
9418 LASAINE AVE                  SE DECISION MADE: 22-JUN-99
NORTHRIDGE, CA 91325              510(k) STATEMENT

DEVICE: TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001
BIOCHECK, INC.                    510(k) NO: K991146(TRADITIONAL)
ATTN: ROBIN J HELLEN              PHONE NO : 818-709-5646
9418 LASAINE AVE                  SE DECISION MADE: 22-JUN-99
NORTHRIDGE, CA 91325              510(k) STATEMENT

DEVICE: TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
BIOCHECK, INC.                    510(k) NO: K991311(TRADITIONAL)
ATTN: ROBIN J HELLEN              PHONE NO : 818-709-5646
9418 LASAINE AVE                  SE DECISION MADE: 02-JUN-99
NORTHRIDGE, CA 91325              510(k) STATEMENT

DEVICE: BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
BIOCHECK, INC.                    510(k) NO: K991432(TRADITIONAL)
ATTN: ROBIN J HELLEN              PHONE NO : 818-709-5646
9418 LASAINE AVE                  SE DECISION MADE: 02-JUN-99
NORTHRIDGE, CA 91325              510(k) STATEMENT

DEVICE: EPI-FOAM SILICONE SHEETING
BIODERMIS CORP.                   510(k) NO: K991604(TRADITIONAL)
ATTN: JEFF S SCHLEUNING           PHONE NO : 800-322-3729
3078 EAST SUNSET RD. SUITE #1     SE DECISION MADE: 09-JUN-99
LAS VEGAS, NV 89120               510(k) STATEMENT

DEVICE: BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, B
BIOMED PRODUCTS                   510(k) NO: K991199(TRADITIONAL)
ATTN: TIMOTHY  THYGESON           PHONE NO : 707-576-1924
5262 VISTA GRANDE DR.             SE DECISION MADE: 22-JUN-99
SANTA ROSA, CA 95403              510(k) STATEMENT

DEVICE: RC BUTTRESS
BIOMET, INC.                      510(k) NO: K991009(TRADITIONAL)
ATTN: TRACY  BICKEL               PHONE NO : 219-372-1761
AIRPORT INDUSTRIAL PARK           SE DECISION MADE: 23-JUN-99
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587

BIOMET, INC.                      510(k) NO: K991987(SPECIAL)
ATTN: DALENE  HUFZIGER BINKLEY    PHONE NO : 219-372-1612
AIRPORT INDUSTRIAL PARK           SE DECISION MADE: 28-JUN-99
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587

DEVICE: BIONIKE AQ BARBITURATE TEST
BIONIKE, INC.                     510(k) NO: K990280(TRADITIONAL)
ATTN: CLEVE W LAIRD               PHONE NO : 805-522-6223
1420 LOS ANGELES AVENUE           SE DECISION MADE: 28-JUN-99
SUITE 201                         510(k) SUMMARY AVAILABLE FROM FDA
SIMI VALLEY, CA 93065

DEVICE: BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005
BIOSENSOR CORP.                   510(k) NO: K990956(TRADITIONAL)
ATTN: STEVE  SPRINGROSE           PHONE NO : 612-890-5135
11481 RUPP DRIVE                  SE DECISION MADE: 14-JUN-99
BURNSVILLE, MN 55337              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOTEST ANTI-EBV RECOMBINANT
BIOTEST DIAGNOSTICS CORP.         510(k) NO: K983839(TRADITIONAL)
ATTN: PATRICIA E BONNESS          PHONE NO : 609-397-8511
66 FORD RD., SUITE 131            SE DECISION MADE: 09-JUN-99
DENVILLE, NJ 07834                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG
BIOTEST DIAGNOSTICS CORP.         510(k) NO: K983841(TRADITIONAL)
ATTN: PATRICIA E BONNESS          PHONE NO : 609-397-8511
66 FORD RD., SUITE 131            SE DECISION MADE: 09-JUN-99
DENVILLE, NJ 07834                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOTEST ANTI-EBV RECOMBINANT, EA IGM
BIOTEST DIAGNOSTICS CORP.         510(k) NO: K983842(TRADITIONAL)
ATTN: PATRICIA E BONNESS          PHONE NO : 609-397-8511
66 FORD RD., SUITE 131            SE DECISION MADE: 09-JUN-99
DENVILLE, NJ 07834                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777
BIOTRONIK, INC.                   510(k) NO: K990483(TRADITIONAL)
ATTN: JON  BRUMBAUGH              PHONE NO : 888-345-0374
6024 JEAN RD.                     SE DECISION MADE: 03-JUN-99
LAKE OSWEGO, OR 97035-5369        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1
BOSTON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K991831(TRADITIONAL)
ATTN: DONALD  BROKS               PHONE NO : 781-213-9200
591 NORTH AVE., SUITE 5           SE DECISION MADE: 11-JUN-99
WAKEFIELD, MA 01880               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
BOSTON SCIENTIFIC CORP.           510(k) NO: K990864(TRADITIONAL)
ATTN: ABBY  LIPMAN                PHONE NO : 508-650-8249
ONE BOSTON SCIENTIFIC PLACE       SE DECISION MADE: 11-JUN-99
NATICK, MA 01760                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM
BOSTON SCIENTIFIC CORP.           510(k) NO: K991056()
ATTN: DANIEL J DILLON             PHONE NO : 508-650-8751
ONE BOSTON SCIENTIFIC DRIVE       SE DECISION MADE: 22-JUN-99
NATICK, MA 01760                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BONE SCREWS
BREGMA INTERNATIONAL TRADING COMPA510(k) NO: K990351(TRADITIONAL)
ATTN: ASSEM  HEDAYAT              PHONE NO : 306 934 8270
214-111 RESEARCH DRIVE            SE DECISION MADE: 01-JUN-99
SASKATOON, SASKATCHEWAN, CANADA S7510(k) STATEMENT

DEVICE: STAINLESS STEEL FIXATION PINS
BREGMA INTERNATIONAL TRADING COMPA510(k) NO: K990353(TRADITIONAL)
ATTN: ASSEM  HEDAYAT              PHONE NO : 306 934 8270
214-111 RESEARCH DRIVE            SE DECISION MADE: 01-JUN-99
SASKATOON, SASKATCHEWAN, CANADA S7510(k) STATEMENT

DEVICE: BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE
BRIGHTSWAY HOLDINGS SDN BHD       510(k) NO: K991750(TRADITIONAL)
ATTN: G.  BASKARAN                PHONE NO : 603 343 1007
BATU BELAH                        SE DECISION MADE: 23-JUN-99
KLANG SELANGOR DARUL EHSAN, MALAYS510(k) STATEMENT

DEVICE: BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CON
BRIGHTSWAY HOLDINGS SDN BHD       510(k) NO: K991752(TRADITIONAL)
ATTN: G.  BASKARAN                PHONE NO : 603 343 1007
BATU BELAH                        SE DECISION MADE: 23-JUN-99
KLANG SELANGOR DARUL EHSAN, MALAYS510(k) STATEMENT

DEVICE: BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)
BRIGHTWAY HOLDINGS SDN. BHD.      510(k) NO: K990876(TRADITIONAL)
ATTN: G.  BASKARAN                PHONE NO : 603 343 1007
LOT 1559, JALAN ISTIMEWA          SE DECISION MADE: 23-JUN-99
BATU BELAH, KLANG                 510(k) STATEMENT
SELANGOR DARUL EHSAN, MALAYSIA 42100

DEVICE: CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES
C.V. ANLIS ABADI INTERNASIONAL    510(k) NO: K991155(TRADITIONAL)
ATTN: ANWAR  FIRMAN               PHONE NO : 626 155 7758573068
JALAN SEKIP BARU, NO 23           SE DECISION MADE: 21-JUN-99
MEDAN, INDONESIA                  510(k) STATEMENT

DEVICE: CADISCOPE ELECTRONIC STETHOSCOPE
CADITEC AG                        510(k) NO: K990809(TRADITIONAL)
ATTN: BETTY  LOCK                 PHONE NO : 847-949-3109
ONE MEDICAL PLACE                 SE DECISION MADE: 09-JUN-99
MUNDELEIN, IL 60060               510(k) SUMMARY AVAILABLE FROM FDA


DEVICE: CARDIOLIGHT
CAPINTEC, INC.                    510(k) NO: K982448(TRADITIONAL)
ATTN: MARY ANNE  DELL             PHONE NO : 412-963-1988
540 ALPHA DR.                     SE DECISION MADE: 11-JUN-99
PITTSBURGH, PA 15238              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TENDER TOUCH SILICONE GEL PADS
CAPITAL MARKETING TECHNOLOGIES, IN510(k) NO: K991478(TRADITIONAL)
ATTN: JOHN  SNYDER                PHONE NO : 800-887-3370
3630 SOUTH I 35, SUITE A          SE DECISION MADE: 21-JUN-99
WACO, TX 76706                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TELEMEDICINE 2000
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K991307(SPECIAL)
ATTN: LEONID  TRACHTENBERG        PHONE NO : 972 894 84600
2 PERERIS ST., SCIENCE PARK       SE DECISION MADE: 14-JUN-99
REHOVOT, ISRAEL 76100             510(k) STATEMENT

DEVICE: MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EG
CARDIAC PATHWAYS CORP.            510(k) NO: K990795(TRADITIONAL)
ATTN: ERIN  DIGNAN                PHONE NO : 408-737-0505
995 BENECIA AVE.                  SE DECISION MADE: 08-JUN-99
SUNNYVALE, CA 94086               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERALAS DIODE LASER SYSTEM, MODEL CERALAS D15
CERAMOPTEC, INC.                  510(k) NO: K991891(TRADITIONAL)
ATTN: CAROL J MORELLO             PHONE NO : 413-525-0600
515 SHAKER ROAD                   SE DECISION MADE: 24-JUN-99
EAST LONGMEADOW, MA 01028         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-1
CHALGREN ENT., INC.               510(k) NO: K982950(TRADITIONAL)
ATTN: RICHARD  KAISER             PHONE NO : 408-847-3994
8021 CARMEL ST.                   SE DECISION MADE: 22-JUN-99
GILROY, CA 95020                  510(k) STATEMENT

DEVICE: CHIRON DIAGNOSTICS ACS: 180 FOLATE
CHIRON DIAGNOSTICS CORP.          510(k) NO: K991582(TRADITIONAL)
ATTN: WILLIAM J PIGNATO           PHONE NO : 508-359-3825
63 NORTH ST.                      SE DECISION MADE: 30-JUN-99
MEDFIELD, MA 02052-1688           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHIRON DIAGNOSTICS ACS: 180 FT3
CHIRON DIAGNOSTICS CORP.          510(k) NO: K991692(TRADITIONAL)
ATTN: WILLIAM J PIGNATO           PHONE NO : 508-359-3825
63 NORTH ST.                      SE DECISION MADE: 18-JUN-99
MEDFIELD, MA 02052-1688           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRAN
CIVCO MEDICAL INSTRUMENTS CO., INC510(k) NO: K991236(TRADITIONAL)
ATTN: J. WILLIAM  JONES           PHONE NO : 319-656-4447
102 FIRST ST. SOUTH               SE DECISION MADE: 02-JUN-99
KALONA, IA 52247                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTSPOT 2000
CMT MEDICAL TECHNOLOGIES, LTD.    510(k) NO: K991578(SPECIAL)
ATTN: YESHAYAHU  RAZ              PHONE NO : 972 485 66233
MATAM HIGH TECHNOLOGY CENTER      SE DECISION MADE: 03-JUN-99
HAIFA, ISRAEL 31905               510(k) STATEMENT

DEVICE: MODIFICATION TO WOUN'DRES
COLOPLAST CORP.                   510(k) NO: K991202(TRADITIONAL)
ATTN: HARVEY M ARBIT              PHONE NO : 507-386-4308
1940 COMMERCE DR.                 SE DECISION MADE: 04-JUN-99
P.O. BOX 8300                     510(k) SUMMARY AVAILABLE FROM FDA
NORTH MANKATO, MN 56003-8300

DEVICE: COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS
COLORSOFT LABORATORIES CORP.      510(k) NO: K990815(TRADITIONAL)
ATTN: MARTIN  DALSING             PHONE NO : 970-243-5490
623 GLACIER DRIVE                 SE DECISION MADE: 03-JUN-99
GRANT JUNCTION, CO 81503          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: "HERMES CONTROL CENTER", WITH CONTROL OF THE AESOP 3000HR (HERME
COMPUTER MOTION, INC.             510(k) NO: K991444(TRADITIONAL)
ATTN: DAVID  THOMAS               PHONE NO : 805-968-9600
130-B CREMONA DR.                 SE DECISION MADE: 25-JUN-99
GOLETA, CA 93117                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER
COMPUTER MOTION, INC.             510(k) NO: K991734(SPECIAL)
ATTN: DAVID U THOMAS              PHONE NO : 805-968-9600
130 CREMONA DRIVE, SUITE B        SE DECISION MADE: 09-JUN-99
GOLETA, CA 93117                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX
CONMED CORP.                      510(k) NO: K991855(SPECIAL)
ATTN: IRA D DUESLER JR            PHONE NO : 315-797-8375
310 BROAD ST.                     SE DECISION MADE: 15-JUN-99
UTICA, NY 13501-1203              510(k) STATEMENT

DEVICE: COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL
COOPERSURGICAL, INC.              510(k) NO: K990850(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W.       SE DECISION MADE: 01-JUN-99
WASHINGTON, DC 20004-1109         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COOPERSURGICAL INFRARED COAGULATOR
COOPERSURGICAL, INC.              510(k) NO: K990852(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W.       SE DECISION MADE: 11-JUN-99
WASHINGTON, DC 20004-1109         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 6F HYDROLYSER THROMBECTOMY CATHETER
CORDIS CORP.                      510(k) NO: K990771(TRADITIONAL)
ATTN: ARIEL  MACTAVISH            PHONE NO : 305-824-2404
14201 N.W. 60TH AVE.              SE DECISION MADE: 25-JUN-99
MIAMI LAKES, FL 33014             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORDIS MAXI DS PTA BALLOON CATHETER
CORDIS CORP.                      510(k) NO: K991811(SPECIAL)
ATTN: ARIEL  MACTAVISH            PHONE NO : 305-824-2332
14201 N.W. 60TH AVE.              SE DECISION MADE: 15-JUN-99
MIAMI LAKES, FL 33014             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) X
DADE BEHRING, INC.                510(k) NO: K983344(TRADITIONAL)
ATTN: LORRAINE H PIESTRAK         PHONE NO : 302-631-6279
RT. 896, GLASCOW BLDG. 500        SE DECISION MADE: 22-JUN-99
NEWARK, DE 19714                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION OF N PROTEIN STANDARD SL
DADE BEHRING, INC.                510(k) NO: K991181(TRADITIONAL)
ATTN: CAROLYN K GEORGE            PHONE NO : 781-826-2073
P.O. BOX 6101                     SE DECISION MADE: 01-JUN-99
NEWARK, DE 19714-6101             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: N/T PROTEIN CONTROL LC
DADE BEHRING, INC.                510(k) NO: K991704(TRADITIONAL)
ATTN: REBECCA S AYASH             PHONE NO : 781-826-2073
GLASGOW SITE                      SE DECISION MADE: 25-JUN-99
P.O. BOX 6101                     510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714

DEVICE: DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
DADE MICROSCAN, INC.              510(k) NO: K983922(TRADITIONAL)
ATTN: CYNTHIA  VAN DUKER          PHONE NO : 916-374-3105
2040 ENTERPRISE BLVD.             SE DECISION MADE: 17-JUN-99
WEST SACRAMENTO, CA 95691         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MO
DAKO CORP.                        510(k) NO: K991402(TRADITIONAL)
ATTN: GRETCHEN M MURRAY           PHONE NO : 805-566-6655
6392 VIA REAL                     SE DECISION MADE: 21-JUN-99
CARPINTERIA, CA 93013             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOUSE IGG1 NEGATIVE CONTROLS
DAKO CORP.                        510(k) NO: K991454(TRADITIONAL)
ATTN: GRETCHEN M MURRAY           PHONE NO : 805-566-6655
6392 VIA REAL                     SE DECISION MADE: 21-JUN-99
CARPINTERIA, CA 93013             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DAUM MRI/CONVENTIONAL BIOPSY KIT
DAUM GMBH                         510(k) NO: K991366(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 410-451-0639
P.O. BOX 4341                     SE DECISION MADE: 25-JUN-99
CROFTON, MD 21114                 510(k) STATEMENT

DEVICE: BARD SPERMA-TEX PRESHAPED MESH (2.4"X5.6"), MODEL 0114700
DAVOL, INC., SUB. C.R. BARD, INC. 510(k) NO: K991637(TRADITIONAL)
ATTN: RINI  GEORGEKUTTY           PHONE NO : 401-463-7000
100 SOCKANOSSETT CROSSROAD        SE DECISION MADE: 22-JUN-99
CRANSTON, RI 02920                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE
DAYSPRING MEDICAL, INC.           510(k) NO: K991003(TRADITIONAL)
ATTN: NEIL  RASMUSSEN             PHONE NO : 303-442-4514
1936 BEACON CT.                   SE DECISION MADE: 09-JUN-99
BOULDER, CO 80302                 510(k) STATEMENT

DEVICE: VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICA
DAYSPRING MEDICAL, INC.           510(k) NO: K991005(TRADITIONAL)
ATTN: NEIL  RASMUSSEN             PHONE NO : 303-442-4514
1936 BEACON CT.                   SE DECISION MADE: 22-JUN-99
BOULDER, CO 80302                 510(k) STATEMENT

DEVICE: P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY
DEPUY ORTHOPAEDICS, INC.          510(k) NO: K991106(TRADITIONAL)
ATTN: JANET G JOHNSON             PHONE NO : 219-267-8143
700 ORTHOPAEDIC DR.               SE DECISION MADE: 09-JUN-99
WARSAW, IN 46581-0988             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
DERMAPHYLYX, INC.                 510(k) NO: K991061(TRADITIONAL)
ATTN: ANDREW M REED               PHONE NO : 781-933-4772
78-E,, OLYMPIA AVENUE             SE DECISION MADE: 28-JUN-99
WOBURN, MA 01801-3933             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTACHOICE INSTRUMENTS
DEXIDE, INC.                      510(k) NO: K991814(SPECIAL)
ATTN: JOHN  CORZINE               PHONE NO : 817-589-1454
7509 FLAGSTONE DR.                SE DECISION MADE: 23-JUN-99
FORT WORTH, TX 76118-6995         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5
DIAGNOSTIC PRODUCTS CORP.         510(k) NO: K991795(SPECIAL)
ATTN: EDWARD M LEVINE             PHONE NO : 310-645-8200
5700 WEST 96TH ST.                SE DECISION MADE: 09-JUN-99
LOS ANGELES, CA 90045             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
DIAGNOSTIC PRODUCTS CORP.         510(k) NO: K991796(SPECIAL)
ATTN: EDWARD M LEVINE             PHONE NO : 310-645-8200
5700 WEST 96TH ST.                SE DECISION MADE: 09-JUN-99
LOS ANGELES, CA 90045             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5
DIAGNOSTIC PRODUCTS CORP.         510(k) NO: K991797(SPECIAL)
ATTN: EDWARD M LEVINE             PHONE NO : 310-645-8200
5700 WEST 96TH ST.                SE DECISION MADE: 09-JUN-99
LOS ANGELES, CA 90045             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
DIAGNOSTIC SYSTEMS LABORATORIES, I510(k) NO: K990138(TRADITIONAL)
ATTN: JOHN  CLASS                 PHONE NO : 281-332-9678
445 MEDICAL CENTER BLVD.          SE DECISION MADE: 21-JUN-99
WEBSTER, TX 77598                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COPALIS MULTIPLEX EBV ANTIBODY ASSAY
DIASORIN INC.                     510(k) NO: K991660(TRADITIONAL)
ATTN: JUDITH J SMITH              PHONE NO : 301-497-0005
9175 GUIFORD ROAD                 SE DECISION MADE: 04-JUN-99
COLUMBIA, MD 21046                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIXION INTRAMEDULLARY NAILING SYSTEM
DISCO-O-TECH MEDICAL TECHNOLOGIES,510(k) NO: K990717(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202-637-5600
COLUMBIA SQUARE                   SE DECISION MADE: 02-JUN-99
555 THIRTEENTH STREET, NW         510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004-1109

DEVICE: DAHEDI INSULIN INFUSION PUMP
DISETRONIC MEDICAL SYSTEMS        510(k) NO: K991376(TRADITIONAL)
ATTN: PATRIK DE  HAES             PHONE NO : 612-571-6878
7690 CAMERON CIRCLE               SE DECISION MADE: 15-JUN-99
FORT MYERS, FL 33912              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DRG TITANIUM BONE PLATE
DOCTOR'S RESEARCH GROUP, INC.     510(k) NO: K990920(TRADITIONAL)
ATTN: RICHARD  DESLAURIERS        PHONE NO : 203-879-9422
143 WOLCOTT RD.                   SE DECISION MADE: 10-JUN-99
WOLCOTT, CT 06716                 510(k) STATEMENT

DEVICE: DORNIER LASERTRODE FIBER
DORNIER SURGICAL PRODUCTS, INC.   510(k) NO: K991183(TRADITIONAL)
ATTN: CAROL  WERNECKE             PHONE NO : 770-426-1315
1155 ROBERTS BLVD.                SE DECISION MADE: 09-JUN-99
KENNESAW, GA 30144                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INDEPENDENCE 624
EAGLE PARTS AND PRODUCTS, INC.    510(k) NO: K990122(TRADITIONAL)
ATTN: CHARLES B WALKER JR.        PHONE NO : 706-729-9911
1811 WILKINSON RD.                SE DECISION MADE: 25-JUN-99
AUGUSTA, GA 30904                 510(k) STATEMENT

DEVICE: INDEPENDENCE 324
EAGLE PARTS AND PRODUCTS, INC.    510(k) NO: K990484(TRADITIONAL)
ATTN: CHARLES B WALKER            PHONE NO : 706-729-9911
1811 WILKINSON RD.                SE DECISION MADE: 25-JUN-99
AUGUSTA, GA 30904                 510(k) STATEMENT

DEVICE: LYNX ULTRASOUND SYSTEM
ECTON, INC.                       510(k) NO: K991872(TRADITIONAL)
ATTN: CHRISTOPHER B KNELL         PHONE NO : 215-283-1800
110 WEST BUTLER AVENUE            SE DECISION MADE: 16-JUN-99
SUITE 100                         510(k) SUMMARY AVAILABLE FROM FDA
AMBLER, PA 19002

DEVICE: DIFOTI SYSTEM
ELECTRO-OPTICAL SCIENCES, INC     510(k) NO: K991098(TRADITIONAL)
ATTN: PAMELA  PAPINEAU            PHONE NO : 978-772-3552
5 WHITCOMB AVE                    SE DECISION MADE: 30-JUN-99
AYER, MA 01432                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
ELECTROMED, INC.                  510(k) NO: K982889(TRADITIONAL)
ATTN: CHET  SIEVERT               PHONE NO : 612-932-9387
14920 MINNETONKA IND. ROAD        SE DECISION MADE: 01-JUN-99
MINNETONKA, MN 55345              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FOUNDATION POROUS HIP STEM
ENCORE ORTHOPEDICS, INC.          510(k) NO: K991226(TRADITIONAL)
ATTN: DEBBIE  DE LOS SANTOS       PHONE NO : 512-834-6237
9800 METRIC BLVD.                 SE DECISION MADE: 01-JUN-99
AUSTIN, TX 78758                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 8MM FORGED CEMENTED STEM
ENCORE ORTHOPEDICS, INC.          510(k) NO: K991227(TRADITIONAL)
ATTN: DEBBIE  DE LOS SANTOS       PHONE NO : 512-834-6237
9800 METRIC BLVD.                 SE DECISION MADE: 01-JUN-99
AUSTIN, TX 78758                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION OF ENCORE LINEAR POROUS COATED HIP
ENCORE ORTHOPEDICS, INC.          510(k) NO: K991325(TRADITIONAL)
ATTN: DEBBIE  DE LOS SANTOS       PHONE NO : 512-834-6237
9800 METRIC BLVD.                 SE DECISION MADE: 25-JUN-99
AUSTIN, TX 78758                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GRIT BLASTED HUMERAL STEM
ENCORE ORTHOPEDICS, INC.          510(k) NO: K991603(TRADITIONAL)
ATTN: DEBBIE  DE LOS SANTOS       PHONE NO : 512-834-6237
9800 METRIC BLVD.                 SE DECISION MADE: 29-JUN-99
AUSTIN, TX 78758                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION BITE
ESPE DENTAL AG                    510(k) NO: K991008(TRADITIONAL)
ATTN: ANDREAS  PETERMANN          PHONE NO : 011 498 1527001395
ESPE PLATZ                        SE DECISION MADE: 18-JUN-99
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOPATH ENDOSCOPIC INSTRUMENTS
ETHICON ENDO-SURGERY, INC.        510(k) NO: K984240(ABBREVIATED)
ATTN: JACKIE A STRASSER           PHONE NO : 513-786-7978
4545 CREEK ROAD                   SE DECISION MADE: 22-JUN-99
CINCINNATI, OH 45242-2839         510(k) SUMMARY AVAILABLE FROM FDA


DEVICE: INSIGHT MILLENNIUM
FASSTECH                          510(k) NO: K990778(TRADITIONAL)
ATTN: LEE  BRODY                  PHONE NO : 781-229-1500
155 MIDDLESEX TURNPIKE            SE DECISION MADE: 03-JUN-99
BURLINGTON, MA 01803              510(k) STATEMENT

DEVICE: ORASCOPE
FIBERDENT CORP.                   510(k) NO: K991011(TRADITIONAL)
ATTN: MARY  MCNAMARA-CULLINANE    PHONE NO : 508-643-0434
49 PLAIN STREET                   SE DECISION MADE: 23-JUN-99
NORTH ATTLEBORO, MA 02760         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIES
FOTONA D.D.                       510(k) NO: K990243(TRADITIONAL)
ATTN: MOJCA  VALJAVEC             PHONE NO : 386 611 511215
STEGNE 7,                         SE DECISION MADE: 09-JUN-99
1210 LJUBLJANA, SLOVENIA 1210     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS
FRESENIUS HEMOTECHNOLOGY, INC.    510(k) NO: K984586(TRADITIONAL)
ATTN: VIRGINIA R SINGER           PHONE NO : 925-688-0990
110 MASON CIRCLE SUITE A          SE DECISION MADE: 29-JUN-99
CONCORD, CA 94520-1238            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION
FUJI MEDICAL SYSTEMS U.S.A., INC. 510(k) NO: K991257(TRADITIONAL)
ATTN: JOSEPH  AZARY               PHONE NO : 203-602-3677
419 WEST AVE.                     SE DECISION MADE: 25-JUN-99
STAMFORD, CT 06902                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GASTRIC AND RECTAL CATHETERS
G & J ELECTRONICS, INC.           510(k) NO: K973844(TRADITIONAL)
ATTN: SAM  JUNDLER                PHONE NO : 416 733 0528
6 DORNFELL STREET                 SE DECISION MADE: 04-JUN-99
WILLOWDALE, ONTARIO, CANADA M2R2Y6510(k) STATEMENT

DEVICE: DISTENDER SERIES II BAROSTAT
G & J ELECTRONICS, INC.           510(k) NO: K991288(TRADITIONAL)
ATTN: SAM  JUNDLER                PHONE NO : 416 733 0528
6 DORNFELL STREET                 SE DECISION MADE: 08-JUN-99
WILLOWDALE, ONTARIO, CANADA M2R2Y6510(k) STATEMENT

DEVICE: FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B)
G.T. LABORATORIES, INC.           510(k) NO: K991780(TRADITIONAL)
ATTN: JOHN M SZABOCSIK            PHONE NO : 312-553-0828
203 NORTH WABASH AVENUE           SE DECISION MADE: 29-JUN-99
SUITE 1200                        510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60601

DEVICE: FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS
G.T. LABORATORIES, INC.           510(k) NO: K991781(TRADITIONAL)
ATTN: JOHN M SZABOCSIK            PHONE NO : 312-553-0828
203 NORTH WABASH AVENUE           SE DECISION MADE: 29-JUN-99
SUITE 1200                        510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60601

DEVICE: HISPEED NX/I CT SCANNER SYSTEM
GE MEDICAL SYSTEMS, INC.          510(k) NO: K991716(TRADITIONAL)
ATTN: LARRY A KROGER              PHONE NO : 414-544-3894
P.O. BOX 414                      SE DECISION MADE: 18-JUN-99
MILWAUKEE, WI 53201               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING
GE VINGMED ULTRASOUND             510(k) NO: K991842(TRADITIONAL)
ATTN: PAUL  FREDRIKSEN            PHONE NO : 011 473 3021107
P.O. BOX 141                      SE DECISION MADE: 11-JUN-99
HORTEN, NORWAY N-3191             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GE LOGIQ 500
GENERAL ELECTRIC CO.              510(k) NO: K991611(SPECIAL)
ATTN: ALLEN  SCHUH                PHONE NO : 414-647-4385
P.O. BOX 414                      SE DECISION MADE: 09-JUN-99
MILWAUKEE, WI 53201               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENYX MEDICAL INJECTION NEEDLE
GENYX MEDICAL INC.                510(k) NO: K990996(TRADITIONAL)
ATTN: JUDY F GORDON               PHONE NO : 949-454-4177
36 ARGONAUT, SUITE 100            SE DECISION MADE: 18-JUN-99
ALISO VIEJO, CA 92656-1467        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
GENZYME SURGICAL PRODUCTS CORP.   510(k) NO: K991191(TRADITIONAL)
ATTN: MARY E GRAY                 PHONE NO : 508-677-6512
600 AIRPORT ROAD                  SE DECISION MADE: 22-JUN-99
FALL RIVER, MA 02720-4740         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE
GREINER MEDITECH, INC.            510(k) NO: K991843(TRADITIONAL)
ATTN: DOUG  HARRIS                PHONE NO : 410-836-8228
260 GATEWAY DR., SUITE 17A        SE DECISION MADE: 25-JUN-99
BEL AIR, MD 21014                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
GUIDANT CORP.                     510(k) NO: K991102(TRADITIONAL)
ATTN: STACEY  SIMON               PHONE NO : 909-914-4527
26531 YNEZ RD.                    SE DECISION MADE: 09-JUN-99
TEMECULA, CA 92591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GYRUS ENDOUROLOGY SYSTEM
GYRUS MEDICAL LTD.                510(k) NO: K990628(TRADITIONAL)
ATTN: DAVID  KAY                  PHONE NO : 440 122 2300100
ST. MELLONS                       SE DECISION MADE: 29-JUN-99
CARDIFF, UNITED KINGDOM CF3 OLT   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)
HARDCOVER PRODUCTS INC.           510(k) NO: K990925(ABBREVIATED)
ATTN: GERRY  GLAZER               PHONE NO : 905 660 8700
55 ADMINISTRATION RD., UNIT 12    SE DECISION MADE: 17-JUN-99
CONCORD, ONTARIO, CANADA L4K 4G9  510(k) STATEMENT

DEVICE: HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)
HARDCOVER PRODUCTS INC.           510(k) NO: K991047(ABBREVIATED)
ATTN: GERRY  PERSON               PHONE NO : 905 660 8700
55 ADMINISTRATION RD., UNIT 12    SE DECISION MADE: 18-JUN-99
CONCORD, ONTARIO, CANADA L4K 4G9  510(k) STATEMENT

DEVICE: SELF CURE COMPOSITE
HARRY J. BOSWORTH CO.             510(k) NO: K991488(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN         PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE.            SE DECISION MADE: 21-JUN-99
SKOKIE, IL 60076                  510(k) STATEMENT

DEVICE: FLC COMPOSITE
HARRY J. BOSWORTH CO.             510(k) NO: K991491(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN         PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE.            SE DECISION MADE: 21-JUN-99
SKOKIE, IL 60076                  510(k) STATEMENT

DEVICE: POLYSLIT IFE KIT
HELENA LABORATORIES               510(k) NO: K990998(TRADITIONAL)
ATTN: PAT  FRANKS                 PHONE NO : 800-231-5663
1530 LINDBERGH DR.                SE DECISION MADE: 28-JUN-99
PO BOX 752                        510(k) STATEMENT
BEAUMONT, TX 77704

DEVICE: BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS
HELIX MEDICAL, INC.               510(k) NO: K991587(TRADITIONAL)
ATTN: CYNTHIA  ANDERSON           PHONE NO : 805-684-3304
1110 MARK AVE.                    SE DECISION MADE: 25-JUN-99
CARPINTERIA, CA 93013             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13
HENNING KNUDSEN ENGINEERING A/S   510(k) NO: K991229(TRADITIONAL)
ATTN: JACOB  MOLLENBACH           PHONE NO : 454 594 0440
KLINTEHOJ VAENGE 1                SE DECISION MADE: 29-JUN-99
BIRKEROD, DENMARK DK-3460         510(k) STATEMENT

DEVICE: XANTOPREN COMFORT
HERAEUS KULZER, INC.              510(k) NO: K991425(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN          PHONE NO : 219-299-6662
4315 SOUTH LAFAYETTE BLVD.        SE DECISION MADE: 15-JUN-99
SOUTH BEND, IN 46614-2517         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP
HEWLETT-PACKARD GMBH              510(k) NO: K991773(SPECIAL)
ATTN: EGON  PFEIL                 PHONE NO : 703-114-2243
HERRENBERGER STR. 110-140         SE DECISION MADE: 07-JUN-99
BOEBLINGEN, GERMANY 71034         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
HITACHI MEDICAL CORP. OF AMERICA  510(k) NO: K991318(TRADITIONAL)
ATTN: GARY W ENOS                 PHONE NO : 330-405-3330
9177 DUTTON DR.                   SE DECISION MADE: 18-JUN-99
TWINSBURG, OH 44056               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR
HOWMEDICA OSTEONICS CORP.         510(k) NO: K990922(TRADITIONAL)
ATTN: KAREN  ARIEMMA              PHONE NO : 201-760-8187
59 ROUTE 17                       SE DECISION MADE: 02-JUN-99
ALLENDALE, NJ 07401-1677          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE I
HOWMEDICA OSTEONICS CORP.         510(k) NO: K991952(SPECIAL)
ATTN: MARYBETH  NAUGHTON          PHONE NO : 201-934-4376
59 ROUTE 17                       SE DECISION MADE: 29-JUN-99
ALLENDALE, NJ 07401-1677          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO
I-FLOW CORP.                      510(k) NO: K991513(TRADITIONAL)
ATTN: ROBERT J BARD               PHONE NO : 949-206-2700
20202 WINDROW DR.                 SE DECISION MADE: 21-JUN-99
LAKE FOREST, CA 92630             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PANATOME
IMAGING SCIENCES INTL., INC.      510(k) NO: K991518(TRADITIONAL)
ATTN: ROBERT E HAY                PHONE NO : 215-997-5666
1910 NORTH PENN RD.               SE DECISION MADE: 18-JUN-99
HATFIELD, PA 19440                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501
IMAGYN MEDICAL TECHNOLOGIES, INC. 510(k) NO: K991526(SPECIAL)
ATTN: CHERYL  BLAKE               PHONE NO : 714-708-7748
3050 REDHILL AVE.                 SE DECISION MADE: 17-JUN-99
COSTA MESA, CA 92626              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPLEX RADIAL HEAD REPLACEMENT SYSTEM
IMPLEX CORP.                      510(k) NO: K984290(TRADITIONAL)
ATTN: JOHN  SCHALAGO              PHONE NO : 201-818-1800
80 COMMERCE DR.                   SE DECISION MADE: 01-JUN-99
ALLENDALE, NJ 07401-1600          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPLEX ALUMINA FEMORAL HEAD
IMPLEX CORP.                      510(k) NO: K990183(TRADITIONAL)
ATTN: ROBERT  POGGIE              PHONE NO : 201-818-1800
80 COMMERCE DR.                   SE DECISION MADE: 11-JUN-99
ALLENDALE, NJ 07401-1600          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMTEC BIOPIN
IMTEC CORP.                       510(k) NO: K982951(TRADITIONAL)
ATTN: M.K.  PATTERSON             PHONE NO : 405-223-4456
2401 NORTH COMMERCE               SE DECISION MADE: 21-JUN-99
ARDMORE, OK 73401                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INVIGRA
INDUS MEDICARE LTD.               510(k) NO: K991374(ABBREVIATED)
ATTN: P.K.  REDDY                 PHONE NO : 914 077 60241
144, S.P. RD., BEGUMPET           SE DECISION MADE: 15-JUN-99
HYDERABAD ANDHRA PRADESH, INDIA 50510(k) STATEMENT

DEVICE: METRA PS PROCEDURE KIT
INLET MEDICAL, INC.               510(k) NO: K984600(TRADITIONAL)
ATTN: MARK  STERRETT              PHONE NO : 502-634-5900
2400 CRITTENDEN DRIVE             SE DECISION MADE: 03-JUN-99
LOUISVILLE, KY 40217              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTA LITE ANA ELISA
INOVA DIAGNOSTICS, INC.           510(k) NO: K991657(TRADITIONAL)
ATTN: BRYS C MYERS                PHONE NO : 619-586-9900
10180 SCRIPPS RANCH BLVD.         SE DECISION MADE: 17-JUN-99
SAN DIEGO, CA 92131               510(k) STATEMENT

DEVICE: FRAMELESS NEUROMATE
INTEGRATED SURGICAL SYSTEMS, INC. 510(k) NO: K991081(TRADITIONAL)
ATTN: R.D.  HIBBERT               PHONE NO : 530-792-2600
1850 RESEARCH PARK DR.            SE DECISION MADE: 25-JUN-99
DAVIS, CA 95616                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DOSE CALC, MODEL VS. 1.02
INTEGRITY MEDICAL SOFTWARE, INC.  510(k) NO: K990833(TRADITIONAL)
ATTN: CRAIG A LAUGHTON            PHONE NO : 903-595-0209
403 MOCKINGBIRD LANE              SE DECISION MADE: 08-JUN-99
TYLER, TX 75701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERSOURCE 125, MODEL 1251L
INTERNATIONAL BRACHYTHERAPY, INC. 510(k) NO: K984235(TRADITIONAL)
ATTN: RUTH  FEICHT                PHONE NO : 770-582-0662
6000 LIVE OAK PARKWAY,            SE DECISION MADE: 09-JUN-99
SUITE 107                         510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30093

DEVICE: SYNERGY ADJUSTABLE LENGTH ROD
INTERPORE CROSS INTL.             510(k) NO: K990057(TRADITIONAL)
ATTN: LYNN M RODARTI              PHONE NO : 949-453-3200
181 TECHNOLOGY DR.                SE DECISION MADE: 28-JUN-99
IRVINE, CA 92618-2402             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE,
INTERSURGICAL, INC.               510(k) NO: K990949(TRADITIONAL)
ATTN: THOMAS R GUNERMAN           PHONE NO : 315-451-2900
417 ELECTRONICS PKWY.             SE DECISION MADE: 15-JUN-99
LIVERPOOL, NY 13088               510(k) STATEMENT

DEVICE: INTRACOIL PERIPHERAL STENT
INTRATHERAPEUTICS, INC.           510(k) NO: K990221(TRADITIONAL)
ATTN: AMY  PETERSON               PHONE NO : 612-937-0322
6271 BURY DR.                     SE DECISION MADE: 02-JUN-99
EDEN PRAIRIE, MN 55436            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARROW FWD POWER WHEELCHAIR
INVACARE CORP.                    510(k) NO: K991168(TRADITIONAL)
ATTN: EDWARD A KROLL              PHONE NO : 440-329-6595
1200 TAYLOR STREET                SE DECISION MADE: 25-JUN-99
ELYRIA, OH 44036                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: "ORTHOGONAL EP CATHETERS"
IRVINE BIOMEDICAL, INC.           510(k) NO: K990958(SPECIAL)
ATTN: ROGER  TU                   PHONE NO : 949-851-3053
2146-A MICHELSON DR.              SE DECISION MADE: 03-JUN-99
IRVINE, CA 92612                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSCOPIC FIBEROPTIC CABLE
ISOLUX AMERICA                    510(k) NO: K991208(TRADITIONAL)
ATTN: STUART L MCGHEE             PHONE NO : 941-514-7475
1479 RAILHEAD BLVD.               SE DECISION MADE: 23-JUN-99
NAPLES, FL 34110-8444             510(k) STATEMENT

DEVICE: JELTEMP
J.F. JELENKO & CO., INC.          510(k) NO: K991564(TRADITIONAL)
ATTN: RAPHAEL  JUDKINS            PHONE NO : 800-431-1785
99 BUSINESS PARK DR.              SE DECISION MADE: 23-JUN-99
ARMONK, NY 10504                  510(k) STATEMENT

DEVICE: ASH ADVANTAGE PERITONEAL CATHETER
JANIN GROUP, INC.                 510(k) NO: K991042(TRADITIONAL)
ATTN: JOHN A NAVIS                PHONE NO : 630-585-1991
615 ENTERPRISE ST.                SE DECISION MADE: 25-JUN-99
AURORA, IL 60504-8138             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S
JAWON MEDICAL CO., LTD.           510(k) NO: K991688(TRADITIONAL)
ATTN: ROBERT D WAXHAM             PHONE NO : 757-365-0978
222 INSTITUTE ST.                 SE DECISION MADE: 01-JUN-99
SMITHFIELD, VA 23430              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIRECT HDL-CHOLESTEROL REAGENT
KAMIYA BIOMEDICAL CO.             510(k) NO: K990581(TRADITIONAL)
ATTN: COLIN  GETTY                PHONE NO : 206-575-8068
910 INDUSTRY DR.                  SE DECISION MADE: 18-JUN-99
SEATTLE, WA 98188-3412            510(k) STATEMENT

DEVICE: K-ASSAY MICROALBUMIN CALIBRATOR SET
KAMIYA BIOMEDICAL CO.             510(k) NO: K991166(TRADITIONAL)
ATTN: COLIN  GETTY                PHONE NO : 206-565-8066
910 INDUSTRY DR.                  SE DECISION MADE: 10-JUN-99
SEATTLE, WA 98188-3412            510(k) STATEMENT

DEVICE: K-ASSAY RHEUMATOID FACTOR
KAMIYA BIOMEDICAL CO.             510(k) NO: K991409(TRADITIONAL)
ATTN: COLIN  GETTY                PHONE NO : 206-575-8068
910 INDUSTRY DR.                  SE DECISION MADE: 09-JUN-99
SEATTLE, WA 98188-3412            510(k) STATEMENT

DEVICE: K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET
KAMIYA BIOMEDICAL CO.             510(k) NO: K991467(TRADITIONAL)
ATTN: COLIN  GETTY                PHONE NO : 206-575-8068
910 INDUSTRY DR.                  SE DECISION MADE: 10-JUN-99
SEATTLE, WA 98188-3412            510(k) STATEMENT

DEVICE: DCI ENDOSCOPE
KARL STORZ ENDOSCOPY              510(k) NO: K991171(TRADITIONAL)
ATTN: KEVIN A KENNAN              PHONE NO : 800-421-0837
600 CORPORATE POINTE              SE DECISION MADE: 23-JUN-99
CULVER CITY, CA 90230-7600        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DCI ENDOSCOPE
KARL STORZ ENDOSCOPY              510(k) NO: K991228(TRADITIONAL)
ATTN: KEVIN  KENNAN               PHONE NO : 310-410-2769
600 CORPORATE POINTE              SE DECISION MADE: 23-JUN-99
CULVER CITY, CA 90230-7600        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KSEA EPIDUROSCOPE
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K991051(TRADITIONAL)
ATTN: KEVIN  KENNAN               PHONE NO : 310-410-2769
600 CORPORATE POINTE              SE DECISION MADE: 01-JUN-99
CULVER CITY, CA 90230-7600        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KSEA NEURO-FIBERSCOPE
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K991069(TRADITIONAL)
ATTN: KEVIN  KENNAN               PHONE NO : 310-410-2769
600 CORPORATE POINTE              SE DECISION MADE: 03-JUN-99
CULVER CITY, CA 90230-7600        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM
KARL STORZ IMAGING, INC.          510(k) NO: K990154(TRADITIONAL)
ATTN: TERRY  FERNANDEZ            PHONE NO : 805-968-5563
175 CREMONA DR.                   SE DECISION MADE: 01-JUN-99
GOLETA, CA 93117                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONOJECT INSULIN SYRINGE
KENDALL CO.                       510(k) NO: K991758(ABBREVIATED)
ATTN: FRANK J FUCILE              PHONE NO : 508-261-8532
15 HAMPSHIRE STREET               SE DECISION MADE: 14-JUN-99
MANSFIELD, MA 02048               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XK-95 HIGH SPEED MOTOR DRILL SYSTEM
KOMET MEDICAL                     510(k) NO: K984035(TRADITIONAL)
ATTN: COURTNEY S PARADICE         PHONE NO : 770-355-9980
1679 KELLOGG SPRINGS DRIVE        SE DECISION MADE: 03-JUN-99
ATLANTA, GA 30338                 510(k) STATEMENT

DEVICE: KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR
KONICA MEDICAL CORP.              510(k) NO: K990969(TRADITIONAL)
ATTN: RUSSELL D MUNVES            PHONE NO : 212-490-4100
THE CHRYSLER BUILDING             SE DECISION MADE: 18-JUN-99
405 LEXINGTON AVENUE              510(k) STATEMENT
NEW YORK, NY 10174

DEVICE: HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE -
LABORATOIRES PRODIMED             510(k) NO: K990913(TRADITIONAL)
ATTN: RANDOLPH L COOKE            PHONE NO : 609-466-0510
23 WELISEWITZ RD.                 SE DECISION MADE: 08-JUN-99
RINGOES, NJ 08551                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTA
LAGLOVE (M) SDN. BHD.             510(k) NO: K991748(TRADITIONAL)
ATTN: G.  BASKARAN                PHONE NO : 603 833 5411
LOT 478, JALAN SIMPANG BALAK,     SE DECISION MADE: 23-JUN-99
OFF BATU 13, JALAN CHERAS         510(k) STATEMENT
KAJANG, SELANGOR, D.E., MALAYSIA 43000

DEVICE: LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CO
LAGLOVE (M) SDN. BHD.             510(k) NO: K991749(TRADITIONAL)
ATTN: G.  BASKARAN                PHONE NO : 603 833 5054
LOT 478, JALAN SIMPANG BALAK,     SE DECISION MADE: 23-JUN-99
OFF BATU 13, JALAN CHERAS         510(k) STATEMENT
KAJANG, SELANGOR, D.E., MALAYSIA 43000

DEVICE: COOLTOUCH "V" ND:YAG
LASER AESTHETICS, INC.            510(k) NO: K983984(TRADITIONAL)
ATTN: JONATHAN M BAUMGARDNER      PHONE NO : 530-823-1434
11802 KEMPER ROAD                 SE DECISION MADE: 07-JUN-99
AUBURN, CA 95603                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEICA AT550
LEICA MICROSYSTEMS, INC.          510(k) NO: K990869(TRADITIONAL)
ATTN: FRANK J DREXELIUS           PHONE NO : 716-686-4548
3374 WALDEN AVE.                  SE DECISION MADE: 07-JUN-99
DEPEW, NY 14043                   510(k) STATEMENT

DEVICE: PILLOWPOSITIVE CERVICAL PILLOW
LIFESLEEP SYSTEMS, INC.           510(k) NO: K990871(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN           PHONE NO : 202-637-5813
555 THIRTEENTH STREET, N.W.       SE DECISION MADE: 10-JUN-99
WASHINGTON, DC 20004-1109         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY
LITTLE NELL LABS, INC.            510(k) NO: K990658(TRADITIONAL)
ATTN: JOEL R. L.  EHRENKRANZ      PHONE NO : 970-927-5253
1676 EAST SOPRIS CREEK RD.        SE DECISION MADE: 02-JUN-99
BASALT, CO 81621                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LONGPORT MODEL LDS -1
LONGPORT, INC.                    510(k) NO: K990238(TRADITIONAL)
ATTN: MICHAEL G FARROW            PHONE NO : 202-223-0298
1625 K STREET, NW                 SE DECISION MADE: 23-JUN-99
SUITE 1000                        510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006-1604

DEVICE: HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLU
M.R.G. INDUSTRIES SDN. BHD.       510(k) NO: K991304(TRADITIONAL)
ATTN: CHONG ENG  LIM              PHONE NO : 605 891 1111
PT. 4004 KAMUNTING IND. ESTATE    SE DECISION MADE: 23-JUN-99
P.O. BOX 9                        510(k) SUMMARY AVAILABLE FROM FDA
KAMUNTING, PERAK, MALAYSIA 34600

DEVICE: HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES
M.R.G. INDUSTRIES SDN. BHD.       510(k) NO: K991305(TRADITIONAL)
ATTN: CHONG ENG  LIM              PHONE NO : 605 891 1111
PT. 4004 KAMUNTING IND. ESTATE    SE DECISION MADE: 21-JUN-99
P.O. BOX 9                        510(k) SUMMARY AVAILABLE FROM FDA
KAMUNTING, PERAK, MALAYSIA 34600

DEVICE: MAERSK MEDICAL CONTOUR INFUSION SET
MAERSK MEDICAL A/S                510(k) NO: K991759(TRADITIONAL)
ATTN: DON  SELVEY                 PHONE NO : 520 527 0107
12744 SAN FERNANDO ROAD           SE DECISION MADE: 25-JUN-99
SYLMAR, CA 91342                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC
MASIMO CORP.                      510(k) NO: K990966(TRADITIONAL)
ATTN: JAMES J CRONIN              PHONE NO : 949-250-9688
2852 KELVIN AVE.                  SE DECISION MADE: 07-JUN-99
IRVINE, CA 92614-5826             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MCKINLEY SP DISPOSABLE INFUSION PUMP
MCKINLEY, INC.                    510(k) NO: K990461(TRADITIONAL)
ATTN: JOHN  MCINROY               PHONE NO : 303-420-9569
4080 YOUNGFIELD ST.               SE DECISION MADE: 30-JUN-99
WHEAT RIDGE, CO 80033             510(k) STATEMENT

DEVICE: MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC C
MEDAMICUS, INC.                   510(k) NO: K990705(TRADITIONAL)
ATTN: DENNIS S MADISON            PHONE NO : 612-559-2613
15301 HWY. 55 WEST                SE DECISION MADE: 28-JUN-99
MINNEAPOLIS, MN 55447             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: METACARPAL FIXATION SYSTEM
MEDCANICA, INC.                   510(k) NO: K991064(TRADITIONAL)
ATTN: AL  WEISENBORN              PHONE NO : 305-829-3437
19526 EAST LAKE DRIVE             SE DECISION MADE: 23-JUN-99
MIAMI, FL 33015                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: `INEAR WRIST COIL, MODEL 440GE-09
MEDICAL ADVANCES, INC.            510(k) NO: K991113(TRADITIONAL)
ATTN: THOMAS E TYNES              PHONE NO : 414-258-3808
10437 INNOVATION DR.              SE DECISION MADE: 10-JUN-99
MILWAUKEE, WI 53226               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LINEAR SHOULDER COIL, MODEL 414GE-09
MEDICAL ADVANCES, INC.            510(k) NO: K991115(TRADITIONAL)
ATTN: THOMAS E TYNES              PHONE NO : 414-258-3808
10437 INNOVATION DR.              SE DECISION MADE: 08-JUN-99
MILWAUKEE, WI 53226               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 11.5F X 6" (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8" (20CM
MEDICAL COMPONENTS, INC.          510(k) NO: K980438(TRADITIONAL)
ATTN: JEANNE M CUSH               PHONE NO : 215-256-4201
1499 DELP DR.                     SE DECISION MADE: 10-JUN-99
HARLEYSVILLE, PA 19438            510(k) STATEMENT

DEVICE: SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ D
MEDICAL COMPONENTS, INC.          510(k) NO: K983511(TRADITIONAL)
ATTN: JEANNE M CUSH               PHONE NO : 215-256-4201
1499 DELP DR.                     SE DECISION MADE: 08-JUN-99
HARLEYSVILLE, PA 19438            510(k) STATEMENT

DEVICE: PRONTO DRY
MEDICAL INSTRUMENTS CORPORATION MI510(k) NO: K991248(TRADITIONAL)
ATTN: JOHN C MATHERLY             PHONE NO : 413 262 34355
FRIEDHOFPLATZ 16                  SE DECISION MADE: 22-JUN-99
SOLOTHURN, SWITZERLAND 4502       510(k) STATEMENT

DEVICE: CLIMAX
MEDILATEX SDN. BHD.               510(k) NO: K991049(TRADITIONAL)
ATTN: LEE KIM  LANG               PHONE NO : 607 896 1888
LOT PTB 500, PERINDUSTRIAN        SE DECISION MADE: 15-JUN-99
PKT2, BANDAR TENGGARA             510(k) STATEMENT
KULAI, JOHOR, MALAYSIA 81000

DEVICE: MEDIPOINT
MEDIPOINT LTD.                    510(k) NO: K982961(TRADITIONAL)
ATTN: JULES T MITCHEL             PHONE NO : 212-681-2100
305 MADISON AVENUE, SUITE 2501    SE DECISION MADE: 07-JUN-99
NEW YORK, NY 10165                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL
MEDTEXX INDUSTRIES (THAI) CO. LTD.510(k) NO: K991153(TRADITIONAL)
ATTN: STEPHEN TAN  CKENG KIM      PHONE NO : 661 230 3606
200 MU4, TAMBUN TACHANG           SE DECISION MADE: 21-JUN-99
AMPHUR BANGKLAM                   510(k) SUMMARY AVAILABLE FROM FDA
SONGKHLA, THAILAND 90110

DEVICE: MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZO
MENNEN MEDICAL, INC.              510(k) NO: K991775(SPECIAL)
ATTN: KENNETH  RAICHMAN           PHONE NO : 972 893 83030
KIRYAT WEIZMANN                   SE DECISION MADE: 24-JUN-99
P.O. BOX 102                      510(k) SUMMARY AVAILABLE FROM FDA
ROHOVOT, ISRAEL 76100

DEVICE: PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST
MERIDIAN DIAGNOSTICS, INC.        510(k) NO: K984343(TRADITIONAL)
ATTN: ALAN  NICHOL                PHONE NO : 513-271-3700
3471 RIVER HILLS DR.              SE DECISION MADE: 25-JUN-99
CINCINNATI, OH 45244              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST
MERIDIAN DIAGNOSTICS, INC.        510(k) NO: K984346(TRADITIONAL)
ATTN: ALAN  NICHOL                PHONE NO : 513-271-3700
3471 RIVER HILLS DR.              SE DECISION MADE: 25-JUN-99
CINCINNATI, OH 45244              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FOUNTAIN INFUSION SYSTEM
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K991619(SPECIAL)
ATTN: CHESTER  MCCOY              PHONE NO : 801-253-1600
1600 WEST MERIT PKWY.             SE DECISION MADE: 09-JUN-99
SOUTH JORDAN, UT 84095            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHADOW TRAYS
MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K991107(TRADITIONAL)
ATTN: FELIX  MICK                 PHONE NO : 718-597-3999
1470 OUTLOOK AVE.                 SE DECISION MADE: 29-JUN-99
BRONX, NY 10465                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SY
MICRORECORDING SYSTEMS CONSULTANTS510(k) NO: K991077(TRADITIONAL)
ATTN: ROBERT L ROGERS             PHONE NO : 626-395-0884
2842 E. FOOTHILL BLVD.            SE DECISION MADE: 09-JUN-99
PASADENA, CA 91107                510(k) STATEMENT

DEVICE: ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE
MICROVENA CORP.                   510(k) NO: K991898(SPECIAL)
ATTN: ANGELA  MALLERY             PHONE NO : 651-777-6700
1861 BUERKLE RD.                  SE DECISION MADE: 16-JUN-99
WHITE BEAR LAKE, MN 55110-5246    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACTIWATCH-SCORE
MINI-MITTER CO., INC.             510(k) NO: K991033(TRADITIONAL)
ATTN: JACK E MCKENZIE             PHONE NO : 800-685-2999
PO BOX 3386                       SE DECISION MADE: 23-JUN-99
56885 ENTERPRISE DR.              510(k) SUMMARY AVAILABLE FROM FDA
SUNRIVER, OR 97707

DEVICE: MINIMED 508 INSULIN PUMP
MINIMED TECHNOLOGIES, INC.        510(k) NO: K990801(TRADITIONAL)
ATTN: DON  SELVEY                 PHONE NO : 818-362-5958
12744 SAN FERNANDO ROAD           SE DECISION MADE: 08-JUN-99
SYLMAR, CA 91342                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINIMED 407C INFUSION PUMP, MODEL 407C
MINIMED TECHNOLOGIES, INC.        510(k) NO: K991013(TRADITIONAL)
ATTN: DON  SELVEY                 PHONE NO : 818-362-5958
12744 SAN FERNANDO RD.            SE DECISION MADE: 23-JUN-99
SYLMAR, CA 91342                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUGITA TITANIUM ANEURYSM CLIP
MIZUHO AMERICA, INC.              510(k) NO: K990202(TRADITIONAL)
ATTN: T.WHIT  ATHEY               PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY           SE DECISION MADE: 04-JUN-99
SUITE 625                         510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852

DEVICE: EUCLID REDUCTION AND GUIDANCE SYSTEM
MODULAR CUTTING SYSTEMS INC.      510(k) NO: K991037(TRADITIONAL)
ATTN: ALLEN P SCHLEIN             PHONE NO : 203-336-3526
650 CLINTON AVE.                  SE DECISION MADE: 23-JUN-99
BRIDGEPORT, CT 06605              510(k) STATEMENT

DEVICE: HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL C
MORAX                             510(k) NO: K990250(TRADITIONAL)
ATTN: BOREK  JANIK                PHONE NO : 734-475-2441
13805 WATERLOO ROAD               SE DECISION MADE: 18-JUN-99
CHELSEA, MI 48118                 510(k) STATEMENT

DEVICE: HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15
MORAX                             510(k) NO: K991362(TRADITIONAL)
ATTN: BOREK  JANIK                PHONE NO : 734-475-2441
13805 WATERLOO ROAD               SE DECISION MADE: 21-JUN-99
CHELSEA, MI 48118                 510(k) STATEMENT

DEVICE: MTP UROPUMP DISPOSABLE TUBING SET
MTP MEDICAL TECHNICAL PROMOTION GM510(k) NO: K990909(TRADITIONAL)
ATTN: KEVIN  KENNAN               PHONE NO : 310-410-2769
P.O. BOX 1954                     SE DECISION MADE: 09-JUN-99
CULVER CITY, CA 90232             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS
MTP MEDICAL TECHNICAL PROMOTION GM510(k) NO: K990910(TRADITIONAL)
ATTN: KEVIN  KENNAN               PHONE NO : 310-410-2769
P.O. BOX 1954                     SE DECISION MADE: 03-JUN-99
CULVER CITY, CA 90232             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MTP ARTHROPUMP DISPOSABLE TUBING SET
MTP MEDICAL TECHNICAL PROMOTION GM510(k) NO: K990911(TRADITIONAL)
ATTN: KEVIN  KENNAN               PHONE NO : 310-410-2769
P.O. BOX 1954                     SE DECISION MADE: 03-JUN-99
CULVER CITY, CA 90232             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MTP EXTRACTION BAG
MTP MEDICAL TECHNICAL PROMOTION GM510(k) NO: K990912(TRADITIONAL)
ATTN: KEVIN  KENNAN               PHONE NO : 310-410-2769
P.O. BOX 1954                     SE DECISION MADE: 09-JUN-99
CULVER CITY, CA 90232             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AILEE SUTURES AND AILEE NEEDLES
MYCO MEDICAL SUPPLIES, INC.       510(k) NO: K982646(TRADITIONAL)
ATTN: SANJIV  KUMAR               PHONE NO : 910-678-0680
101 ROSE VALLEY WOODS DR.         SE DECISION MADE: 02-JUN-99
CARY, NC 27513                    510(k) STATEMENT

DEVICE: HYDROTONE-THERMAL CAPSULE SYSTEM
NATS CORP.                        510(k) NO: K991184(ABBREVIATED)
ATTN: RICHARD C LANZILLOTTO       PHONE NO : 516-744-0059
30 NORTHPORT ROAD                 SE DECISION MADE: 23-JUN-99
SOUND BEACH, NY 11789-1734        510(k) STATEMENT

DEVICE: ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
NEOMETRICS, INC.                  510(k) NO: K991498(TRADITIONAL)
ATTN: DAVID  SCHWARTZ             PHONE NO : 516-754-8080
104 BELLEROSE AVE.                SE DECISION MADE: 16-JUN-99
EAST NORTHPORT, NY 11731          510(k) STATEMENT

DEVICE: UNI-CLIP STAPLE
NEWDEAL S.A.                      510(k) NO: K991482(TRADITIONAL)
ATTN: NORMAN F ESTRIN             PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE             SE DECISION MADE: 03-JUN-99
POTOMAC, MD 20854                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES
NIHON KOHDEN, INC.                510(k) NO: K990063(TRADITIONAL)
ATTN: GARY  REASONER              PHONE NO : 949-250-3959
2601 CAMPUS DR.                   SE DECISION MADE: 09-JUN-99
IRVINE, CA 92612-1601             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMORPHOUS DIAMOND COATED DRILL
NOBEL BIOCARE USA, INC.           510(k) NO: K990846(TRADITIONAL)
ATTN: KIM  RENDON                 PHONE NO : 714-282-4800
22895 EAST PARK DR.               SE DECISION MADE: 10-JUN-99
YORBA LINDA, CA 92887             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC
NOBELPHARMA USA, INC.             510(k) NO: K984162(TRADITIONAL)
ATTN: BETSY A BROWN               PHONE NO : 708-654-9100
777 OAKMONT LANE                  SE DECISION MADE: 28-JUN-99
WESTMONT, IL 60559                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HAL SCOPE HOLDER SYSTEM
NOVED MEDICAL                     510(k) NO: K991548(TRADITIONAL)
ATTN: MIKE  GRIFFIN               PHONE NO : 714-366-2944
168 AVENIDA DEL MAR, SUITE 120    SE DECISION MADE: 23-JUN-99
SAN CLEMENTE, CA 92672            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET
NSK NAKANISHI, INC.               510(k) NO: K990954(TRADITIONAL)
ATTN: HIROSHI  SEKIGUCHI          PHONE NO : 028 964 3380
340 KAMIHINATA, KANUMA-SHI        SE DECISION MADE: 09-JUN-99
TOCHIGI-KEN, JAPAN 322            510(k) STATEMENT

DEVICE: SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT
NSK NAKANISHI, INC.               510(k) NO: K991021(TRADITIONAL)
ATTN: HIROJI  SEKIGUCHI           PHONE NO : 028 964 3380
340 KAMIHINATA, KANUMA-SHI        SE DECISION MADE: 23-JUN-99
TOCHIGI-KEN, JAPAN 322            510(k) STATEMENT

DEVICE: NORMA 10
ODIN TECHNOLOGIES LTD.            510(k) NO: K991243(TRADITIONAL)
ATTN: ADI  ICKOWICZ               PHONE NO : 972 495 91010
P.O. BOX 248                      SE DECISION MADE: 18-JUN-99
YOKNEAM ELIT, ISRAEL 20698        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEFLECTABLE TAC ELECTROTHERMAL PROBE
ORATEC INTERVENTIONS, INC.        510(k) NO: K990859(TRADITIONAL)
ATTN: SHEILA  RAMERMAN            PHONE NO : 650-369-9904
3700 HAVEN CT.                    SE DECISION MADE: 14-JUN-99
MENLO PARK, CA 94025              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEFLECTABLE ELECTROSURGICAL PROBES
ORATEC INTERVENTIONS, INC.        510(k) NO: K991190(TRADITIONAL)
ATTN: SHEILA  RAMERMAN            PHONE NO : 650-369-9904
3700 HAVEN CT.                    SE DECISION MADE: 23-JUN-99
MENLO PARK, CA 94025              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COAG-A-MATE MAX
ORGANON TEKNIKA CORP.             510(k) NO: K991101(TRADITIONAL)
ATTN: REBECCA A RIVAS             PHONE NO : 919-620-2288
100 AKZO AVENUE                   SE DECISION MADE: 01-JUN-99
DURHAM, NC 27712                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORIBRUSH - STANDARD - B002
ORIFICE MEDICAL AB                510(k) NO: K991593(TRADITIONAL)
ATTN: PATRIK  NILSSON             PHONE NO : 011 464 1165430
BRONSGATAN 12                     SE DECISION MADE: 29-JUN-99
YSTAD, SWEDEN S-271 39            510(k) STATEMENT

DEVICE: ORIBRUSH - WITH PROTECTIVE TIP - B001
ORIFICE MEDICAL AB                510(k) NO: K991595(TRADITIONAL)
ATTN: PATRIC  NILSSON             PHONE NO : 001 464 1165430
BRONSGATAN 12                     SE DECISION MADE: 29-JUN-99
YSTAD, SWEDEN S-271 39            510(k) STATEMENT

DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNOD
ORTHO-CLINICAL DIAGNOSTICS, INC.  510(k) NO: K990943(TRADITIONAL)
ATTN: ANNE  ZAVERTNIK             PHONE NO : 716-453-3790
100 INDIGO CREEK DRIVE            SE DECISION MADE: 01-JUN-99
ROCHESTER, NY 14626-5101          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCUTRED SHOE
ORTHOPEDIC TECHNOLOGY RESEARCH, IN510(k) NO: K991313(TRADITIONAL)
ATTN: CHERYL G DYER               PHONE NO : 423-870-7207
4717 ADAMS ROAD                   SE DECISION MADE: 23-JUN-99
P.O. BOX 489                      510(k) STATEMENT
HIXSON, TN 37343

DEVICE: OSTEOMED INTRAORAL DISTRACTION SYSTEM
OSTEOMED CORP.                    510(k) NO: K990944(TRADITIONAL)
ATTN: RICK A BUSS                 PHONE NO : 972-241-3401
3750 REALTY RD.                   SE DECISION MADE: 16-JUN-99
ADDISON, TX 75001-4311            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IDS4 V3.2 IMAGE DISPLAY SYSTEM
OTECH, INC.                       510(k) NO: K991643(SPECIAL)
ATTN: HERMAN  OOSTERWIJK          PHONE NO : 940-440-9530
2001 EAST OAKSHORES DRIVE         SE DECISION MADE: 08-JUN-99
CROSSROADS, TX 76227              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PACIFIC HEMOSTASIS THROMBOSCREEN 200
PACIFIC HEMOSTASIS                510(k) NO: K991321(TRADITIONAL)
ATTN: LARRY  KOPYTA               PHONE NO : 412-490-8816
11515 VANSTORY DR.                SE DECISION MADE: 21-JUN-99
HUNTERSVILLE, NC 28078-8144       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP
PACIFIC SURGICAL INNOVATIONS, INC.510(k) NO: K991002(TRADITIONAL)
ATTN: TERRY  JOHNSTON             PHONE NO : 650-802-6988
360 INDUSTRIAL RD., UNIT H        SE DECISION MADE: 11-JUN-99
SAN CARLOS, CA 94070              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: A P HARNESS
PARAWORKS ENTERPRISE, LTD.        510(k) NO: K981860(TRADITIONAL)
ATTN: MICHAEL C CAMPBELL          PHONE NO : 604 871 0040
#1-179 WEST 17TH AVENUE           SE DECISION MADE: 03-JUN-99
VANCOUVER, BRITISH COLUMBIA, CANAD510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RC CORNET, MODEL #44F50
PARI RESPIRATORY EQUIPMENT, INC.  510(k) NO: K983308(TRADITIONAL)
ATTN: MIGUEL A ARRIZON            PHONE NO : 804-639-7235
13800 HULL ST. RD.                SE DECISION MADE: 04-JUN-99
MIDLOTHIAN, VA 23112              510(k) STATEMENT

DEVICE: PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLE
PASSY-MUIR, INC.                  510(k) NO: K990905(TRADITIONAL)
ATTN: PATRICIA E PASSY            PHONE NO : 949-833-8255
4521 CAMPUS DR., SUITE 273        SE DECISION MADE: 11-JUN-99
IRVINE, CA 92612                  510(k) STATEMENT

DEVICE: O.B. APPLICATOR TAMPONS, O.B. TAMPONS
PERSONAL PRODUCTS CO.             510(k) NO: K991118(TRADITIONAL)
ATTN: RALPH  PETRONE              PHONE NO : 908-874-1214
199 GRANDVIEW RD.                 SE DECISION MADE: 29-JUN-99
SKILLMAN, NJ 08558                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)
PERUSAHAAN GETAH ASAS SDN BHD     510(k) NO: K991511(TRADITIONAL)
ATTN: TAN KONG  CHANG             PHONE NO : 603 391 1949
42100 KLANG,                      SE DECISION MADE: 03-JUN-99
P.O. BOX 188, 41720 KLANG         510(k) STATEMENT
SELANGOR, DARUL EHSAN, MALAYSIA 42100

DEVICE: AT HOME COCAINE & THC SCREENING TEST, MODEL 9170
PHAMATECH                         510(k) NO: K991641(SPECIAL)
ATTN: CARL A MONGIOVI             PHONE NO : 619-635-5840
9265 ACTIVITY RD., #112-113       SE DECISION MADE: 01-JUN-99
SAN DIEGO, CA 92126               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AT HOME DRUG TEST, MODEL 9171
PHAMATECH                         510(k) NO: K991824(SPECIAL)
ATTN: CARL A MONGIOVI             PHONE NO : 619-635-5840
9265 ACTIVITY RD., #112-113       SE DECISION MADE: 11-JUN-99
SAN DIEGO, CA 92126               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MTM BIOSCANNER C TEST STRIPS
POLYMER TECHNOLOGY SYSTEMS, INC.  510(k) NO: K990688(TRADITIONAL)
ATTN: MARGO  ENRIGHT              PHONE NO : 317-870-5610
7736 ZIONSVILLE ROAD              SE DECISION MADE: 24-JUN-99
INDIANAPOLIS, IN 46268            510(k) STATEMENT

DEVICE: CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
PRECISION BIOLOGIC                510(k) NO: K990814(TRADITIONAL)
ATTN: SANDY  MORRISON             PHONE NO : 902 468 6422
900 WINDMILL RD., SUITE 100       SE DECISION MADE: 07-JUN-99
DARTMOUTH, N.S., CANADA B3B 1P7   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STATUS CUP ACCUSIGN CUP
PRINCETON BIOMEDITECH CORP.       510(k) NO: K991751(SPECIAL)
ATTN: JEMO  KANG                  PHONE NO : 800-726-2670
4242 U.S. RT. 1                   SE DECISION MADE: 18-JUN-99
MONMOUTH JUNCTION, NJ 08852-1905  510(k) STATEMENT

DEVICE: PRODIMED MICROINJECTION PIPETTES
PRODIMED                          510(k) NO: K983713(TRADITIONAL)
ATTN: RANDOLPH L COOKE            PHONE NO : 609-466-0510
23 WELISEWITZ RD.                 SE DECISION MADE: 08-JUN-99
RINGOES, NJ 08551                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTASE TOTAL GALACTOSE SCREENING ASSAY
QUANTASE LTD.                     510(k) NO: K990644(TRADITIONAL)
ATTN: R.  STEWART CAMPBELL        PHONE NO : 440 173 8444102
3 RIVERVIEW BUSINESS PARK         SE DECISION MADE: 21-JUN-99
FRIARTON ROAD                     510(k) STATEMENT
PERTH, SCOTLAND, UNITED KINGDOM PH2 8DF

DEVICE: QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT
QUANTASE LTD.                     510(k) NO: K990654(TRADITIONAL)
ATTN: R. STEWART  CAMPBELL        PHONE NO : 440 173 8444102
3 RIVERVIEW BUSINESS PARK         SE DECISION MADE: 21-JUN-99
FRIARTON ROAD                     510(k) STATEMENT
PERTH, SCOTLAND, UNITED KINGDOM PH2 8DF

DEVICE: SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
R & D SYSTEMS, INC.               510(k) NO: K991876(TRADITIONAL)
ATTN: SUE  GALLO                  PHONE NO : 612-379-2956
614 MCKINLEY PL., N.E.            SE DECISION MADE: 17-JUN-99
MINNEAPOLIS, MN 55413             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CAR
RAPID MFG. CO.                    510(k) NO: K982096(ABBREVIATED)
ATTN: CHARITY  MARTIN             PHONE NO : 404-696-1113
3800 WENDELL DR. SW               SE DECISION MADE: 18-JUN-99
SUITE 204                         510(k) STATEMENT
ATLANTA, GA 30336

DEVICE: OVERLANDER PEV 2000
RAYE'S, INC.                      510(k) NO: K983497(TRADITIONAL)
ATTN: WILLARD L FRICKEY           PHONE NO : 800-537-6454
204 WEST 2ND ST.                  SE DECISION MADE: 27-JUN-99
ELLIS, KS 67637                   510(k) STATEMENT

DEVICE: FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K991178(TRADITIONAL)
ATTN: RPBERT L CASARSA            PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY          SE DECISION MADE: 11-JUN-99
VERNON HILLS, IL 60061            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROCHE COBAS INTEGRA SERUM BARBITURATES
ROCHE DIAGNOSTICS CORP.           510(k) NO: K991440(TRADITIONAL)
ATTN: LISA M GERARD               PHONE NO : 317-576-3362
9115 HAGUE RD.                    SE DECISION MADE: 22-JUN-99
INDIANAPOLIS, IN 46250-0457       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
ROCHE DIAGNOSTICS CORP.           510(k) NO: K991443(TRADITIONAL)
ATTN: LISA M GERARD               PHONE NO : 317-576-3362
9115 HAGUE RD.                    SE DECISION MADE: 22-JUN-99
INDIANAPOLIS, IN 46250-0457       510(k) STATEMENT

DEVICE: RS-4V MUSCLE STIMULATOR
RS MEDICAL                        510(k) NO: K990697(TRADITIONAL)
ATTN: MIKE  MCGRAW                PHONE NO : 360-892-0339
P.O. BOX 4656                     SE DECISION MADE: 18-JUN-99
VANCOUVER, WA 98662-0656          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM
RYMED TECHNOLOGIES, INC.          510(k) NO: K991653(TRADITIONAL)
ATTN: AL  WEISENBORN              PHONE NO : 305-829-3437
19526 EAST LAKE DRIVE             SE DECISION MADE: 24-JUN-99
MIAMI, FL 33015                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LC MICROFILL
S & C POLYMER GMBH                510(k) NO: K991442(TRADITIONAL)
ATTN: JURGEN  ENGELBRECHT         PHONE NO : 494 121 8619
ROBERT-BOSCH-STR. 5               SE DECISION MADE: 03-JUN-99
D-25335                           510(k) SUMMARY AVAILABLE FROM FDA
ELMSHORN, GERMANY

DEVICE: SURGISORB
SAMYANG CORP.                     510(k) NO: K984374(TRADITIONAL)
ATTN: DAVID W SCHLERF             PHONE NO : 925-356-2640
200 GREGORY LANE, SUITE C-100     SE DECISION MADE: 04-JUN-99
PLEASANT HILL, CA 94523-3389      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3D ANATOMICAL MESH
SANTERRA MEDICAL TECHNOLOGY, INC. 510(k) NO: K990930(TRADITIONAL)
ATTN: DAVID P LANG                PHONE NO : 651-704-9160
5451 HILLTOP AVE.                 SE DECISION MADE: 17-JUN-99
LAKE ELMO, MN 55042-9539          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SARGON IMMEDIATE LOAD IMPLANT, MODEL D
SARGON ENT., INC.                 510(k) NO: K981141(TRADITIONAL)
ATTN: DANIEL J MANELLI            PHONE NO : 202-261-1000
2000 M STREET NW  #700            SE DECISION MADE: 23-JUN-99
WASHINGTON, DC 20036              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SE
SEIKO INSTRUMENTS USA, INC.       510(k) NO: K991282(TRADITIONAL)
ATTN: HERMAN  OOSTERWJICK         PHONE NO : 940-440-9330
2001 EAST OAKSHORES DR.           SE DECISION MADE: 30-JUN-99
CROSSROADS, TX 76227              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
SHANGHAI INTCO. PLASTIC & RUBBER P510(k) NO: K990186(TRADITIONAL)
ATTN: FRANK  LIU                  PHONE NO : 909-590-9358
13945 MAGNOLIA AVE                SE DECISION MADE: 21-JUN-99
CHINO, CA 91710                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EX
SHIELD GLOVES MANUFACTURER (M) SDN510(k) NO: K991743(TRADITIONAL)
ATTN: E. J.  SMITH                PHONE NO : 410-451-0639
P.O. BOX 4341                     SE DECISION MADE: 23-JUN-99
CROFTON, MD 21114                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION G
SHIELD GLOVES MANUFACTURER (M) SDN510(k) NO: K991744(TRADITIONAL)
ATTN: E. J.  SMITH                PHONE NO : 410-451-0639
P.O. BOX 4341                     SE DECISION MADE: 23-JUN-99
CROFTON, MD 21114                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GL
SHIELD GLOVES MANUFACTURER (M) SDN510(k) NO: K991745(TRADITIONAL)
ATTN: E. J.  SMITH                PHONE NO : 410-451-0639
P.O. BOX 4341                     SE DECISION MADE: 23-JUN-99
CROFTON, MD 21114                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATION GLO
SHIELD GLOVES MANUFACTURER (M) SDN510(k) NO: K991746(TRADITIONAL)
ATTN: E. J.  SMITH                PHONE NO : 410-451-0639
P.O. BOX 4341                     SE DECISION MADE: 23-JUN-99
CROFTON, MD 21114                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL EXAMINATION GLOVES
SHIJIAZHUANG BRETHREN PLASTIC CO.,510(k) NO: K983856(TRADITIONAL)
ATTN: XIN-LAI  ZHOU               PHONE NO : 011 860 3117702144
NO. 37  ZHONGHUA SOUTH STREET     SE DECISION MADE: 21-JUN-99
SHIJIAZHUANG, HEBEI, CHINA        510(k) STATEMENT

DEVICE: POWDERED VINYL EXAMINATION GLOVE
SHIJIAZHUANG BRETHREN PLASTIC CO.,510(k) NO: K983893(TRADITIONAL)
ATTN: XIN-LAI  ZHOU               PHONE NO : 863 117 024360
NO. 37  ZHONGHUA SOUTH STREET     SE DECISION MADE: 21-JUN-99
SHIJIAZHUANG, HEBEI, CHINA        510(k) STATEMENT

DEVICE: SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS
SHIMADZU CORP.                    510(k) NO: K991553(ABBREVIATED)
ATTN: MICHAEL  FISHBACK           PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVENUE        SE DECISION MADE: 08-JUN-99
TORRANCE, CA 90502-1328           510(k) STATEMENT

DEVICE: SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION
SIEMENS CORP.                     510(k) NO: K991600(SPECIAL)
ATTN: ALICIA  BUSTOS-JUERGENSEN   PHONE NO : 732-321-3243
186 WOOD AVE., SOUTH              SE DECISION MADE: 09-JUN-99
ISELIN, NJ 08830                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIEMENS INFINITY EEG POD
SIEMENS MEDICAL SYSTEMS, INC.     510(k) NO: K991012(TRADITIONAL)
ATTN: PENELOPE H GRECO            PHONE NO : 978-907-7500
16 ELECTRONICS AVE.               SE DECISION MADE: 24-JUN-99
DANVERS, MA 01923                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CADD-TPN ADMINISTRATION SET, MODEL 21-7071
SIMS DELTEC, INC.                 510(k) NO: K991255(TRADITIONAL)
ATTN: EDWARD W NUMAINVILLE        PHONE NO : 651-628-7166
1265 GREY FOX RD.                 SE DECISION MADE: 09-JUN-99
ST. PAUL, MN 55112                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND
SIMS DELTEC, INC.                 510(k) NO: K991301(TRADITIONAL)
ATTN: EDWARD W NUMAINVILLE        PHONE NO : 651-628-7166
1265 GREY FOX RD.                 SE DECISION MADE: 09-JUN-99
ST. PAUL, MN 55112                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CADD ADMINISTRATION SET
SIMS DELTEC, INC.                 510(k) NO: K991599(TRADITIONAL)
ATTN: EDWARD W NUMAINVILLE        PHONE NO : 651-682-7166
1265 GREY FOX RD.                 SE DECISION MADE: 15-JUN-99
ST. PAUL, MN 55112                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS
SMARTLIGHT, INC.                  510(k) NO: K991302(TRADITIONAL)
ATTN: A. ROBERT  SOHOVAL          PHONE NO : 201-487-4544
241 MAIN ST.                      SE DECISION MADE: 01-JUN-99
HACKENSACK, NJ 07601              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPERA CUPFLANGED ACETABULAR COMPONENTS
SMITH & NEPHEW, INC., ORTHOPAEDIC 510(k) NO: K991538(ABBREVIATED)
ATTN: JANET JOHNSON  GREEN        PHONE NO : 901-396-2121
1450 BROOKS RD.                   SE DECISION MADE: 03-JUN-99
MEMPHIS, TN 38116                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIVOSONIC
SONOTECH, INC.                    510(k) NO: K984562(TRADITIONAL)
ATTN: MARGARET J LARSON           PHONE NO : 360-671-9121
774 MARINE DR.                    SE DECISION MADE: 08-JUN-99
BELLINGHAM, WA 98225              510(k) STATEMENT

DEVICE: SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM
SPACELABS MEDICAL, INC.           510(k) NO: K983996(TRADITIONAL)
ATTN: NANCY J GERTLAR             PHONE NO : 425-867-7315
15220 N.E. 40TH ST.               SE DECISION MADE: 03-JUN-99
REDMOND, WA 98073-9713            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOQUANT CARDIAC ASSESSMENT CONTROLS
SPECTRAL DIAGNOSTICS INC.         510(k) NO: K991447(TRADITIONAL)
ATTN: JOSEPH P LAURINO            PHONE NO : 416 626 3233
135-2 THE WEST MALL               SE DECISION MADE: 11-JUN-99
TORONTO, ONTARIO, CANADA M9C1C2   510(k) STATEMENT

DEVICE: THERMAL CAUTERY DEVICE, FORCEPS
STARION INSTRUMENTS               510(k) NO: K990728(TRADITIONAL)
ATTN: GEORGE D HERMANN            PHONE NO : 087-418-8773
22900 CONGRESS SPRINGS ROAD       SE DECISION MADE: 03-JUN-99
SARATOGA, CA 95070                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HISTOFREEZER DEVICE
STC TECHNOLOGIES, INC.            510(k) NO: K990877(TRADITIONAL)
ATTN: R. SAM  NIEDBALA            PHONE NO : 610-882-1820
1745 EATON AVE.                   SE DECISION MADE: 14-JUN-99
BETHLEHEM, PA 18018               510(k) STATEMENT

DEVICE: STERIS SMOKE EVACUATION SYSTEM
STERIS CORP.                      510(k) NO: K991167(ABBREVIATED)
ATTN: ROBERT H MCCALL             PHONE NO : 334-277-6660
2720 GUNTER PARK EAST             SE DECISION MADE: 03-JUN-99
MONTGOMERY, AL 36109              510(k) STATEMENT

DEVICE: STERI-PAK LF BOWIE-DICK TEST PACK
STERITEC PRODUCTS MFG. CO., INC.  510(k) NO: K990246(TRADITIONAL)
ATTN: LON  BRUSO                  PHONE NO : 303-660-4201
680 ATCHISON WAY, SUITE 600       SE DECISION MADE: 10-JUN-99
CASTLE ROCK, CO 80104             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER INFRAVISION ESOPHAGEAL KIT
STRYKER ENDOSCOPY                 510(k) NO: K983220(TRADITIONAL)
ATTN: SEAN  CAHILL                PHONE NO : 408-567-2469
2590 WALSH AVE.                   SE DECISION MADE: 04-JUN-99
SANTA CLARA, CA 95051             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REMOVABLE CUFF ABUTMENT
SULZER CALCITEK INC.              510(k) NO: K984536(TRADITIONAL)
ATTN: FOSTER  BOOP                PHONE NO : 760-431-9515
2320 FARADAY AVE.                 SE DECISION MADE: 16-JUN-99
CARLSBAD, CA 92008                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGNA-ROM 21 KNEE SYSTEEM
SULZER ORTHOPEDICS, INC.          510(k) NO: K991143(TRADITIONAL)
ATTN: SHAVAWN  PARDUHN            PHONE NO : 512-432-9360
9900 SPECTRUM DR.                 SE DECISION MADE: 11-JUN-99
AUSTIN, TX 78717                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMNI-FIX, HUMERAL NAIL
SURGICAL IMPLANTS, INC.           510(k) NO: K991405(TRADITIONAL)
ATTN: DOUGLAS W STUART            PHONE NO : 941-366-1882
962 SOUTH TAMIAMI TRAIL, #203     SE DECISION MADE: 29-JUN-99
SARASOTA, FL 34326                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLO ORTHO
SYBRON DENTAL SPECIALTIES INC.    510(k) NO: K990743(TRADITIONAL)
ATTN: COLLEEN  BOSWELL            PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE          SE DECISION MADE: 04-JUN-99
ORANGE, CA 92867                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTEC-E IRRIGATION SYSTEM
SYBRON DENTAL SPECIALTIES INC.    510(k) NO: K991035(TRADITIONAL)
ATTN: COLLEEN  BOSWELL            PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE          SE DECISION MADE: 24-JUN-99
ORANGE, CA 92867                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND
SYMTEX HEALTHCARE CORP.           510(k) NO: K991215(TRADITIONAL)
ATTN: RICHARD S WANG              PHONE NO : 909-468-2186
783 PINEFALLS AVE.                SE DECISION MADE: 11-JUN-99
WALNUT, CA 91789                  510(k) STATEMENT

DEVICE: SYNTHES QUICK LOCK IMF SYSTEM
SYNTHES (USA)                     510(k) NO: K991004(TRADITIONAL)
ATTN: SHERI L MUSGNUNG            PHONE NO : 610-647-9700
P.O. BOX 1766, 1690 RUSSELL       SE DECISION MADE: 23-JUN-99
ROAD                              510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19399

DEVICE: SYNTHES LOCKING CALCANEAL PLATES
SYNTHES (USA)                     510(k) NO: K991407(TRADITIONAL)
ATTN: SHERI L MUSGNUNG            PHONE NO : 610-647-9700
1690 RUSSELL ROAD                 SE DECISION MADE: 11-JUN-99
POST OFFICE BOX 1766              510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301

DEVICE: SYNTHES PEDIATRIC ROD SYSTEM
SYNTHES (USA)                     510(k) NO: K991552(SPECIAL)
ATTN: JONATHAN  GILBERT           PHONE NO : 610-647-9700
P.O. BOX 1766                     SE DECISION MADE: 02-JUN-99
1690 RUSSELL ROAD                 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222

DEVICE: QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE
SYNTRON BIORESEARCH, INC.         510(k) NO: K990325(TRADITIONAL)
ATTN: CLEVE W LAIRD               PHONE NO : 805-522-6223
1420 LOS ANGELES AVE.             SE DECISION MADE: 24-JUN-99
SUITE 201                         510(k) SUMMARY AVAILABLE FROM FDA
SIMI VALLEY, CA 93065

DEVICE: AUTODOSE INFUSION SYSTEM
TANDEM MEDICAL, INC.              510(k) NO: K990889(TRADITIONAL)
ATTN: ALBERT  MISAJON             PHONE NO : 619-673-3900
15910 BERNARDO CENTER DRIVE       SE DECISION MADE: 03-JUN-99
SAN DIEGO, CA 92127               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC
TE ME NA S.A.R.L.                 510(k) NO: K990020(TRADITIONAL)
ATTN: DONALD F RYAN               PHONE NO : 813-796-6916
21981 U.S. 19N                    SE DECISION MADE: 24-JUN-99
CLEARWATER, FL 33765              510(k) STATEMENT

DEVICE: K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK I
TERUMO EUROPE N.V.                510(k) NO: K984576(TRADITIONAL)
ATTN: M J AERTS                   PHONE NO : 003 216 381211
RESEARCHPARK ZONE 2               SE DECISION MADE: 14-JUN-99
INTERLEUVENLAAN 40                510(k) SUMMARY AVAILABLE FROM FDA
LEUVEN 3001, BELGIUM 3001

DEVICE: CAPIOX CARDIOPLEGIA
TERUMO MEDICAL CORP.              510(k) NO: K982467(TRADITIONAL)
ATTN: SANDI  HARTKA               PHONE NO : 410-392-7231
125 BLUE BALL ROAD                SE DECISION MADE: 23-JUN-99
ELKTON, MD 21921                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHET
TERUMO MEDICAL CORP.              510(k) NO: K991406(TRADITIONAL)
ATTN: KRISTINE  WAGNER            PHONE NO : 410-392-7241
125 BLUE BALL RD.                 SE DECISION MADE: 16-JUN-99
ELKTON, MD 21921                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE BLUE NITRILE GLOVE
TG MEDICAL SDN BHD                510(k) NO: K990668(TRADITIONAL)
ATTN: LIM WEE  CHAI               PHONE NO : 603 392 7880
LOT 5091, JALAN TERATAI, BT 5,    SE DECISION MADE: 03-JUN-99
OFF JLN MERU                      510(k) STATEMENT
KLANG, SELANGOR D.E., MALAYSIA 41050

DEVICE: SSA-370A/POWERVISION 6000
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K991710(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714-730-5000
2441 MICHELLE DR.                 SE DECISION MADE: 03-JUN-99
P.O. BOX 2068                     510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92681-2068

DEVICE: SSA-390A/POWER VISION 8000
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K991858(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714-730-5000
2441 MICHELLE DR.                 SE DECISION MADE: 16-JUN-99
P.O. BOX 2068                     510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92681-2068

DEVICE: AIA-PACK CA 125
TOSOH MEDICS, INC.                510(k) NO: K990431(TRADITIONAL)
ATTN: JUDITH E LOEBEL             PHONE NO : 650-615-4970
347 OYSTER POINT BLVD.,           SE DECISION MADE: 03-JUN-99
SUITE 201                         510(k) STATEMENT
SOUTH SAN FRANCISCO, CA 94080

DEVICE: ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000,
TROPHY RADIOLOGIE                 510(k) NO: K991455(TRADITIONAL)
ATTN: MARIE-PIERRE  LABAT-CAMY    PHONE NO : 331 648 08500
4 RUE F. PELLOUTIER CROISSY       SE DECISION MADE: 25-JUN-99
BEAUBOURG                         510(k) STATEMENT
MARNE LA VALLEE CEDEX 2, FRANCE 77437

DEVICE: MODIFICATION TO DIGIPAN
TROPHY RADIOLOGIE                 510(k) NO: K991912(TRADITIONAL)
ATTN: MARIR-PIERRE  LABAT-CAMY    PHONE NO : 331 648 08500
4 RUE F. PELLOUTIER CROISSY       SE DECISION MADE: 22-JUN-99
BEABOURG                          510(k) STATEMENT
MARNE LA VALLEE CEDEX 2, FRANCE 77437

DEVICE: AUTO SUTURE ABBI SYSTEM
UNITED STATES SURGICAL CORP.      510(k) NO: K983296(TRADITIONAL)
ATTN: CHRISTOPHER A GRAHAM        PHONE NO : 203-845-1390
150 GLOVER AVE.                   SE DECISION MADE: 04-JUN-99
NORWALK, CT 06856                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEXIDE BIPOLAR FORCEPS II ** DEVICE
UNITED STATES SURGICAL CORP.      510(k) NO: K991859(TRADITIONAL)
ATTN: CHRISTOPHER A GRAHAM        PHONE NO : 203-845-1390
150 GLOVER AVE.                   SE DECISION MADE: 23-JUN-99
NORWALK, CT 06856                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LATEX EXAMINATION GLOVES (POWDER FREE)
USG HEALTHGUARD SDN BHD           510(k) NO: K991689(TRADITIONAL)
ATTN: TOH CHEE  YEONG             PHONE NO : 603 635 3882
LOT 2756 JALAN KEMPAS LAMA        SE DECISION MADE: 24-JUN-99
(OFF 8 MILES JALAN SKUDAI)        510(k) STATEMENT
SKUDAI, JOHOR BAHRU, JOHOR, MALAYSIA 81300

DEVICE: LATEX EXAMINATION GLOVES (PRE POWDERED)
USG HEALTHGUARD SDN BHD           510(k) NO: K991690(TRADITIONAL)
ATTN: TOH CHEE  YEONG             PHONE NO : 603 635 3882
LOT 2756 JALAN KEMPAS LAMA        SE DECISION MADE: 24-JUN-99
(OFF 8 MILES JALAN SKUDAI)        510(k) STATEMENT
SKUDAI, JOHOR BAHRU, JOHOR, MALAYSIA 81300
DEVICE: RPM RESPIRATORY GATING SYSTEM
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K983629(TRADITIONAL)
ATTN: LINDA S NASH                PHONE NO : 650-424-6990
3045 HANOVER STREET               SE DECISION MADE: 08-JUN-99
M/S H055                          510(k) SUMMARY AVAILABLE FROM FDA
PALO ALTO, CA 94304-1129

DEVICE: EXPLOR-X 70
VILLA SISTEMI MEDICALI S.P.A.     510(k) NO: K991310(TRADITIONAL)
ATTN: AL  SOSA                    PHONE NO : 847-459-3889
219 MAYER AVE.                    SE DECISION MADE: 18-JUN-99
WHEELING, IL 60090                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR
VISTAKON, JOHNSON & JOHNSON VISION510(k) NO: K991163(TRADITIONAL)
ATTN: MARTINE D MARTINO           PHONE NO : 904-443-1808
4500 SALISBURY ROAD               SE DECISION MADE: 08-JUN-99
SUITE 300                         510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32216

DEVICE: VITAL PEP
VITAL SIGNS, INC.                 510(k) NO: K984468(TRADITIONAL)
ATTN: ANTHONY P MARTINO           PHONE NO : 973-790-1330
20 CAMPUS RD.                     SE DECISION MADE: 01-JUN-99
TOTOWA, NJ 07512                  510(k) STATEMENT

DEVICE: SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE
W & H DENTALWERK BUERMOOS GMBH    510(k) NO: K984508(TRADITIONAL)
ATTN: HERBERT  TRASCHWANDTNER     PHONE NO : 011 43 6274/62360
53 IGNAZ-GLASER-STRASSE           SE DECISION MADE: 25-JUN-99
A-5111                            510(k) STATEMENT
BUERMOOS, AUSTRIA 5111

DEVICE: GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES
WESLEY JESSEN CORP.               510(k) NO: K991000(TRADITIONAL)
ATTN: JOSEPH  FOOS                PHONE NO : 847-294-3306
333 E. HOWARD AVENUE              SE DECISION MADE: 28-JUN-99
DES PLAINES, IL 60018-5903        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND
WESTCON CONTACT LENS CO., INC.    510(k) NO: K992010(SPECIAL)
ATTN: CAROL  NOBLE                PHONE NO : 970-245-3845
611 EISENHAUER ST.                SE DECISION MADE: 29-JUN-99
GRAND JUNCTION, CO 81505          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUJI CATHETER, MODEL CTH001
WINDY HILL TECHNOLOGY, INC.       510(k) NO: K983867(TRADITIONAL)
ATTN: ANGELA B SOITO              PHONE NO : 650-566-2330
1010 HAMILTON COURT               SE DECISION MADE: 09-JUN-99
MENLO COURT, CA 94025             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITOP DRESSING
WONDER & BIOENERGY HI-TECH AMERICA510(k) NO: K990974(TRADITIONAL)
ATTN: ARTHUR KING K MA            PHONE NO : 626-573-9220
108 N. YNEZ AVENUE, SUITE 128     SE DECISION MADE: 09-JUN-99
MONTEREY PARK, CA 91754           510(k) STATEMENT

DEVICE: PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K991123(ABBREVIATED)
ATTN: LYNNE  WITKOWSKI            PHONE NO : 901-867-4620
5677 AIRLINE RD.                  SE DECISION MADE: 01-JUN-99
ARLINGTON, TN 38002               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVE
YTY INDUSTRY (MANJUNG) SDN. BHD.  510(k) NO: K991742(TRADITIONAL)
ATTN: E. J.  SMITH                PHONE NO : 410-451-0639
PO BOX 4341                       SE DECISION MADE: 21-JUN-99
CROFTON, MD 21114                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI
Z-KAT, INC.                       510(k) NO: K984298(TRADITIONAL)
ATTN: RONY  ABOVITZ               PHONE NO : 305-895-9022
11645 BISCAYNE BLVD               SE DECISION MADE: 23-JUN-99
SUITE 304                         510(k) SUMMARY AVAILABLE FROM FDA
MIAMI, FL 33181

DEVICE: ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
ZEUS SCIENTIFIC, INC.             510(k) NO: K991179(TRADITIONAL)
ATTN: MARK J KOPNITSKY            PHONE NO : 908-526-3744
200 EVANS WAY                     SE DECISION MADE: 17-JUN-99
BRANCHBURG, NJ 08876              510(k) STATEMENT

DEVICE: ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.
ZEUS SCIENTIFIC, INC.             510(k) NO: K991610(TRADITIONAL)
ATTN: MARK J KOPNITSKY            PHONE NO : 908-526-3744
200 EVANS WAY                     SE DECISION MADE: 25-JUN-99
BRANCHBURG, NJ 08876              510(k) STATEMENT

 
                                                TOTAL 510(k)s THIS PERIOD   326
                                                TOTAL WITH SUMMARIES        227
                                                TOTAL WITH STATEMENTS        99
    
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