FDA 510(k) Applications Received During May, 1983

FDA 510(k) Number Submission Date Device Name Applicant Contact
K831637 05/23/1983 ACCU-FLUSH ACCU-LINE
K831636 05/23/1983 PERCUTANEOUS INTRODUCER KIT ACCU-LINE
K831635 05/20/1983 ACU-PUNCH ACUDERM, INC.
K831563 05/16/1983 CORONARY GUIDING CATHETER-MODIFIED ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K831717 05/31/1983 CORONARY INFUSION CATHETER ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K831403 05/02/1983 LOW PROFILE STEERABLE BALLOON DILATA ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K831657 05/23/1983 ALKA FIRST AID KIT ALKA, INC.
K831480 05/09/1983 PARAMAX ALKALINE PHOSPHATASE REAGENT- AMERICAN DADE
K831536 05/09/1983 PARAMAX AMALINE REAGENT AMERICAN DADE
K831537 05/09/1983 PARAMAX CREATINE KINASE REAGENT AMERICAN DADE
K831659 05/23/1983 FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE AMERICAN EDWARDS LABORATORIES
K831716 05/27/1983 CAPD - CATHETER ADAPTER AMERICAN MCGAW
K831660 05/23/1983 AMS MALLEABLE PENILE PROSTHESIS AMERICAN MEDICAL SYSTEMS, INC.
K831730 05/31/1983 CONTINUOUS FLUSH DEVICE AMERICAN PHARMASEAL DIV. AHSC
K831729 05/31/1983 PERCUTANEOUS CATHETER INSERTION TRAY AMERICAN PHARMASEAL DIV. AHSC
K831627 05/20/1983 CREATININE REAGENTS B6360-10 AMERICAN SCIENTIFIC PRODUCTS
K831628 05/20/1983 CREATININE REAGENTS B6370-13 AMERICAN SCIENTIFIC PRODUCTS
K831634 05/20/1983 GLUCOSE REAGENT B6360-11 AMERICAN SCIENTIFIC PRODUCTS
K831624 05/20/1983 GLUCOSE REAGENT KITS-B6370-10A AMERICAN SCIENTIFIC PRODUCTS
K831569 05/16/1983 REAGENT CUPS AMERICAN SCIENTIFIC PRODUCTS
K831571 05/16/1983 ROTOR AMERICAN SCIENTIFIC PRODUCTS
K831625 05/20/1983 UREA NITROGEN-BUN-REAGENTS B6360-12 AMERICAN SCIENTIFIC PRODUCTS
K831626 05/20/1983 UREA NITROGEN-BUN-REAGENTS B6370-11A AMERICAN SCIENTIFIC PRODUCTS
K831455 05/06/1983 LEATHER VALVE CUTTER AMERICAN V. MUELLER
K831462 05/06/1983 API UNISCEPT PLUS 140 INOCULATOR ANALYTICAL PRODUCTS, INC.
K831648 05/23/1983 ANCHOR BRAND SURGICAL NEEDLES ANCHOR PRODUCTS CO.
K831565 05/16/1983 MICRO-THIN SURGICAL GLOVE ANSELL, INC.
K831564 05/16/1983 ORTHOPEDIC SURGICAL GLOVE ANSELL, INC.
K831451 05/05/1983 SILCATH CENTRAL CATHETER TRAY SIZE- ARGON MEDICAL CORP.
K831453 05/05/1983 SILCATH CENTRAL CATHETER TRAY W/18 GA ARGON MEDICAL CORP.
K831722 05/31/1983 AC-22 AUTOCLAVE TAPE ARMAK TAPE DIVISION
K831701 05/25/1983 UNIVERSAL PACK ATLANTIC OPTICAL SYSTEMS, INC.
K831431 05/04/1983 AUDIOMETER MODEL-500 AUDIMAX
K831653 05/23/1983 LYOPHILIZED MICROORGANISMS AUSTIN BIOLOGICAL LABORATORIES
K831673 05/23/1983 OXY-SWAB AUSTIN BIOLOGICAL LABORATORIES
K831654 05/23/1983 RIM BETA LACTAMASE TEST AUSTIN BIOLOGICAL LABORATORIES
K831674 05/23/1983 RIM-CAMP TEST AUSTIN BIOLOGICAL LABORATORIES
K831655 05/23/1983 SPECTRUM-10 AUSTIN BIOLOGICAL LABORATORIES
K831672 05/23/1983 SPECTRUM-10 AUSTIN BIOLOGICAL LABORATORIES
K831669 05/23/1983 AXCAN SPERM CUP AXCAN SCIENTIFIC CORP.
K831610 05/19/1983 INTRADISCAL THERAPY NEEDLE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K831438 05/05/1983 ELASTOPLAST BEIERSDORF, INC.
K831439 05/05/1983 ELASTOPLAST T.P.N. BEIERSDORF, INC.
K831434 05/04/1983 ISO-SEP SYSTEM BERWICK MEDICAL PRODUCTS, INC.
K831414 05/02/1983 COLORIMETRIC BUN BIO-ANALYTICS LABORATORIES, INC.
K831478 05/09/1983 LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN BIO-RAD
K831742 05/31/1983 QUANTIMUNE HFSH RIA HUMAN FOLLICLE- BIO-RAD
K831522 05/12/1983 BIO-TEK PERCENT OXYGEN MONITOR 74222 BIO-TEK INSTRUMENTS, INC.
K837605 05/16/1983 MV/CM2 NUMBER X74294 MODEL NUMBER 74229 BIO-TEK INSTRUMENTS, INC.
K831512 05/12/1983 DOSIMETRY RELEASE OF RADIATION STERILIZ BIOMET, INC.
K831513 05/12/1983 KENNEDY TIBIAL COMPONENT BIOMET, INC.
K831676 05/23/1983 BIOSENSOR ASC SYSTEM BIOSENSOR CORP.
K831582 05/17/1983 VARI-SUPPORT NECK POSTURE PILLOW BODY THERAPEUTICS, INC.
K831592 05/17/1983 ANHYDRIC INCUBATORS, CULTURE INCUBATOR BOEKEL INDUSTRIES, INC.
K831422 05/03/1983 BIOFLOW BOMED MEDICAL MFR., LTD.
K831421 05/03/1983 BOMED BIOCON BOMED MEDICAL MFR., LTD.
K831604 05/18/1983 HCG ACCU-STICK BTC DIAGNOSTICS, INC.
K831710 05/27/1983 BARD ABSORPTION DRESSING C.R. BARD, INC.
K831507 05/11/1983 LOW TRAUMA ARTERIAL FILTER H-640 C.R. BARD, INC.
K831705 05/26/1983 WM. HARVEY PARALLEL PLATE MEMBRANE BLOOD C.R. BARD, INC.
K831623 05/20/1983 DIA STRIPS SYSTEM CALIFORNIA IMMUNO DIAGNOSTIC, INC.
K831611 05/19/1983 UNI-THANE CARAPAC SYSTEMS, INC.
K831510 05/12/1983 FREEDOM 19" RECREATIONAL WHEELCHAIR CARBONITE CORP.
K831529 05/12/1983 CCS MODEL SJ-103 IMPLANTABLE ATRIAL CARDIAC CONTROL SYSTEMS, INC.
K831406 05/02/1983 RESTROSPECTIVE ECG MEMORY MODULE CARDIAC EVALUATION CENTER, INC.
K831595 05/17/1983 CASTLE MODEL 3341 & 3441 & 4141 GAS AER CASTLE CO.
K837465 05/03/1983 ALCYON ROTATIONAL COBALT THERAPY CGR MEDICAL CORP.
K831575 05/16/1983 NU-CAP CALCIUM HYDROX. PULP CAPPING COE LABORATORIES, INC.
K831574 05/16/1983 BLOOD GAS QUALITY CONTROL SOFT-86000F COMPUTERMATE, INC.
K831645 05/23/1983 TEMP. BIPOLAR EPICARDIAL LEAD CORDIC CORP.
K831450 05/05/1983 DISPOSABLE STERILE FILTER SYSTEM CORNING MEDICAL & SCIENTIFIC
K831533 05/13/1983 MAGIC T4 125I RADIOIMMUNOASSAY CORNING MEDICAL & SCIENTIFIC
K831613 05/19/1983 MAGIC TM 125I T3 UPTAKE RADIOASSAY CORNING MEDICAL & SCIENTIFIC
K831558 05/16/1983 E-Z PREP COULTER ELECTRONICS, INC.
K831566 05/16/1983 CUI MAMMARY PROTHESIS SIZER COX-UPHUFF INTL.
K831515 05/12/1983 DINAMAP VITAL SIGNS MONITOR #1846 CRITIKON COMPANY,LLC
K831586 05/17/1983 CM-VII PHYSIOLOGIC ANALYZER CYBERMEDIC, INC.
K831556 05/16/1983 VAPOR-PHASE HUMIDIFIER SYSTEM CYGNUS RESEARCH CORP.
K831689 05/24/1983 EMPTY DIALYSATE CONTAINER DELMED, INC.
K831484 05/09/1983 COMPOSI-GLAZE DENPAC CORP.
K831483 05/09/1983 SAVE-A-BAKE PORCELAIN POLISH DENPAC CORP.
K831647 05/23/1983 DENTURE RELINING, REPAIR/REBASING RESIN DENTSPLY INTL.
K831441 05/05/1983 POROCOAT FREEMAN/SAMUELSON TOTAL KNEE DEPUY, INC.
K831532 05/13/1983 OCULAR IRRIGATING CANNULA DEY LABORATORIES, INC.
K831496 05/10/1983 ALLERGEN IMMUNOSORBENTS IP SPECIFIC E DIAGNOSTIC REAGENT TECH.
K831463 05/06/1983 ANA-CHECK DIAGNOSTIC TECHNOLOGY, INC.
K831464 05/06/1983 ASO-CHECK DIAGNOSTIC TECHNOLOGY, INC.
K831468 05/06/1983 B HCG-CHECK DIAGNOSTIC TECHNOLOGY, INC.
K831465 05/06/1983 CRP-CHECK DIAGNOSTIC TECHNOLOGY, INC.
K831466 05/06/1983 HCG-CHECK DIAGNOSTIC TECHNOLOGY, INC.
K831467 05/06/1983 RA-CHECK DIAGNOSTIC TECHNOLOGY, INC.
K831409 05/02/1983 HAEMOLYTE SOLUTION DIALYSIS CLINIC, INC.
K831591 05/17/1983 AORTIC ROOT CANNULA W/INTEGRAL PRESS DLP, INC.
K831646 05/19/1983 SONIC MIST ULTRASONIC HUMIDIFIER DOUGLAS PRODUCTS
K831479 05/09/1983 METAL-BACKED ACETABULAR CUP DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K831699 05/25/1983 STRESS MACHINE DR. WILLIAM F. CURRAN
K831731 05/31/1983 INFANT EVALUATION CARRIER E.M. ADAMS
K831501 05/11/1983 TACTIL EAR EAR THREE SYSTEMS
K837506 05/12/1983 KODAK T-MAT G FILM SO-381 EASTMAN KODAK COMPANY
K831615 05/19/1983 DROP FOOT BRACE EDWARD DILAURO, JR.
K831576 05/16/1983 ORTHOFIX ELECTRO-BIOLOGY, INC.
K831504 05/11/1983 HERPES IDENT. & TYPING TEST HITT ELECTRO-NUCLEONICS LABORATORIES, INC.
K831458 05/06/1983 CARDIOPLEGIA RECIRCULATION SYS-BL 705/A ELECTROMEDICS, INC.
K831743 05/31/1983 STERILE FOLEY CATHETERS & UROLOGICAL ELECTROMEDICS, INC.
K837355 05/03/1983 UNKNOWN ELSCINT, INC.
K831481 05/09/1983 DIXIE USA PTL, PHARYNGEAL TRACHEAL LUMEN EUGENE SCARBERRY
K831433 05/04/1983 EXTRASENSR ULTRAFILTRATION MONITOR EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K831424 05/03/1983 THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K831423 05/03/1983 THERAPEUTIC EXCHANGE SYSTEM EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K831568 05/16/1983 RELIANCE TEMPO OPHTH. INSTR STAND F. & F. KOENIGKRAMER
K831502 05/11/1983 NEPHROLYTE FLAITRON LABORATORIES, INC.
K831476 05/09/1983 NASOPHARYNGEAL AIRWAY-ROBERTAZZI STYLE FLS MEDICAL PRODUCTS, INC.
K831706 05/26/1983 SATO FAMILY FIRST AID KIT FOOD AND DRUG SERVICE, INC.
K831530 05/12/1983 PLASTIC LEG BAG FOREVER-DRY, INC.
K831427 05/03/1983 CYPRANE TEC 4 CONTINUOUS FLOW VAPOR. FRASER HARLAKE, INC.
K831546 05/12/1983 ADAPTIVE PENS & LAP DESK FRED SAMMONS, INC.
K831543 05/12/1983 ADJUST. WEIGHTS-BK5171-05,10,20 BEOK FRED SAMMONS, INC.
K831542 05/12/1983 ADJUSTABLE POLYCENTRIC ELBOW HINGE FRED SAMMONS, INC.
K831549 05/12/1983 ARM SLINGS FRED SAMMONS, INC.
K831540 05/12/1983 COMPRESSOGRIP ELASTIC STUMP SHRINKER# FRED SAMMONS, INC.
K831551 05/12/1983 COMPRESSOGRIP TUBULAR ELASTIC BANDAGE FRED SAMMONS, INC.
K831538 05/12/1983 DELUXE ADJUST-ANGLE BOARD-BK4066 FRED SAMMONS, INC.
K831544 05/12/1983 DELUXE TRACTION EXERCISE GLOVE BK5035 FRED SAMMONS, INC.
K831539 05/12/1983 ECONOMY PLASTIC SOCK-BK2084-AID FRED SAMMONS, INC.
K831550 05/12/1983 FINGER BONIOMETER BK7506 FRED SAMMONS, INC.
K831553 05/12/1983 LEG DRAINAGE BAG STRAP BK6011 FRED SAMMONS, INC.
K831547 05/12/1983 RAISED TOILET SEATS & NAIL CLIPPERS FRED SAMMONS, INC.
K831545 05/12/1983 REACHER & DOOR OPENER FRED SAMMONS, INC.
K831552 05/12/1983 SORBOTHANE VISCO INNER SOLE PAD FRED SAMMONS, INC.
K831548 05/12/1983 SPLINTS FRED SAMMONS, INC.
K831541 05/12/1983 TUB TRANSFER BENCH BK6481 FRED SAMMONS, INC.
K831404 05/02/1983 BLOOD MONITOR BMM 10-4 GAMBRO, INC.
K831606 05/18/1983 GF-180-L HOLLOW FIBER HEMODIALYSIS GAMBRO, INC.
K831677 05/23/1983 HYPER-HYPOTHERMIA UNIT HYPO 10-200 GAMBRO, INC.
K831744 05/31/1983 TRANSCUTANEOUS OXYGEN MONITOR OPTION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K831711 05/27/1983 CMV IGM TEST GULL LABORATORIES, INC.
K831715 05/27/1983 NEUROTRAC HDC CORP.
K831603 05/18/1983 TITAN GE/IEPLATE HELENA LABORATORIES
K831447 05/05/1983 CAPNOMETER W/NEW AIRWAY ADAPTER 47210A HEWLETT-PACKARD CO.
K831583 05/17/1983 GP-303 HIRATA SANGYO CO. USA, INC.
K831694 05/24/1983 RENAK HOFFMANN-LA ROCHE, INC.
K831696 05/25/1983 PORTABLE DEFIBRILLATOR MONITOR 74DRK HONEYWELL, INC.
K831596 05/17/1983 DROP RATE COUNTER #340 IMED CORP.
K831511 05/12/1983 TRACHEOSTOMY TUBE IMPLANT TECHNOLOGY, INC.
K831486 05/10/1983 SC-603 TWIN VALVE INSTRUMENTATION INDUSTRIES, INC.
K831693 05/12/1983 MAXI PADS SCENTED DEODORIZED INT'L CONSUMER DISPOSABLES
K831691 05/24/1983 PRIVATE LABEL DEODORANT MAXISHIELD INT'L CONSUMER DISPOSABLES
K831692 05/24/1983 PRIVATE LABEL DEODORANT MINISHIELDS INT'L CONSUMER DISPOSABLES
K831633 05/20/1983 QUANTUM BIPOLAR CARDIAC PULSE GENERATOR INTERMEDICS, INC.
K831607 05/18/1983 FIAX IGA TEST KIT INTL. DIAGNOSTIC TECHNOLOGY
K831609 05/18/1983 FIAX IGG TEST KIT INTL. DIAGNOSTIC TECHNOLOGY
K831608 05/18/1983 FIAX IGM TEST KIT INTL. DIAGNOSTIC TECHNOLOGY
K831690 05/24/1983 IPOS ANTI-ADDUCTUS SHOE IPOS LUNEBURG
K831671 05/23/1983 MODIFIED SOYBEAN CASEIN DIGEST BROTH ISLE MEDIA AND STERILE PRODUCTS, INC.
K831559 05/16/1983 CERTAIN *DENTAL RESTORATIVE JOHNSON & JOHNSON PROFESSIONALS, INC.
K831493 05/10/1983 DENTURE ADHESIVE SEALS JOHNSON & JOHNSON PROFESSIONALS, INC.
K831425 05/03/1983 MDT CHEMITEST SEE-THRU BAG KENPAK CONVERTERS, INC.
K831411 05/02/1983 GLUCOSE OXIDASE/PEROXIDASE TEST KING DIAGNOSTICS, INC.
K831733 05/31/1983 TEMPERATURE MODULE 242-100 KONTRON INSTRUMENTS, INC.
K831499 05/11/1983 GLUCOSE 3, INLAB REAGENT STRIPS-URINALY LAPROL SCIENTIFIC, INC.
K831498 05/11/1983 URI-TEST 3, INLAB REAGENT STRIPS-URINAL LAPROL SCIENTIFIC, INC.
K837573 05/27/1983 SHARPLAN LASER POSITIONING SYSTEM LASER INDUSTRIES LTD.
K831638 05/23/1983 SINGLE BED ARRHYTHMIA MONITOR AM500 LIFELINE SYSTEMS, INC.
K831531 05/11/1983 SURGICAL ISOLATION BARRIER SYSTEM LONE STAR MEDICAL PRODUCTS, INC.
K831509 05/11/1983 ANGIOGRAPHY KIT W/ADDIT. COMPONENTS MALLINCKRODT CRITICAL CARE
K831567 05/16/1983 FOLEY-TEMP MALLINCKRODT CRITICAL CARE
K831456 05/06/1983 TOXI-LAB CANNABINOID THC SCREEN MARION LABORATORIES, INC.
K831446 05/05/1983 SURGITEK NEPHROSTENT KIT MEC/SURGITEK PRODUCTS
K831401 05/02/1983 SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS MED-WEST, INC.
K831440 05/05/1983 SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 MED-WEST, INC.
K837481 05/09/1983 BF24 DOPPLER MODEL P872 AND P874 MEDASONICS, INC.
K831408 05/02/1983 DNA FLOR MEDASTAT SCIENTIFIC CORP.
K831662 05/23/1983 DISPOSABLE HEMOSTAT (STRAIGHT&CURVED MEDCARE PRODUCTS
K831665 05/23/1983 DISPOSABLE NEEDLE HOLDER MEDCARE PRODUCTS
K831661 05/23/1983 DISPOSABLE SCISSORS MEDCARE PRODUCTS
K831664 05/23/1983 PLASTIC THUMB FORCEPS MEDCARE PRODUCTS
K831663 05/23/1983 TISSUE FORCEPS MEDCARE PRODUCTS
K831474 05/06/1983 MINI PULSATOR MEDELCO LTD.
K831472 05/06/1983 ULTRA PULSATOR MEDELCO LTD.
K831473 05/06/1983 ULTRA PULSATOR MF MEDELCO LTD.
K831413 05/02/1983 SPEC IISX MEDICAL DEVICES, INC.
K831577 05/17/1983 TRACHEA/CUFF INFLATOR W/PRESSURE #583 MEDICAL ELECTRONICS CORP.
K831584 05/17/1983 BAILEY ASPIRATOR/IRRIGATOR MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
K831712 05/27/1983 SURGICAL DRILL BITS MEDICAL SPECIALISTS IN PACKAGING
K831728 05/31/1983 MEDICALEX MEDICALEX
K831605 05/18/1983 HEMATOLOGY PAK MERCEDES SCIENTIFIC CO., INC.
K831487 05/10/1983 ELECTRONEURAL STIMULATOR 12 MERIDIA 12 CORP.
K831599 05/17/1983 MERITEC-STREP GROUP A BETA-HEMOLYTIC MERIDIAN DIAGNOSTICS, INC.
K831702 05/25/1983 RARE-EARTH INTRA-OCULAR MAGNET MIAMI EYE TECHNOLOGY, INC.
K831714 05/27/1983 MICRO-AIRE REPLACEMENT SURG. SAW BLADE MICRO-AIRE SURGICAL INSTRUMENTS, INC.
K831675 05/23/1983 TWIST LOCK DRILL 1120 MICRO-AIRE SURGICAL INSTRUMENTS, INC.
K831514 05/12/1983 AMWA TDA THEOPHYLLINE TEST MILES LABORATORIES, INC.
K831600 05/18/1983 DIASTIX REAGENT STRIPS FOR URINALYSIS MILES LABORATORIES, INC.
K831488 05/10/1983 DAVRON PROF. SCRUB BRUSH-DRY/STERILE MINNETONKA, INC.
K831718 05/31/1983 ELECTRONIC CLINICAL THERMOMETER MITTELOY
K837230 05/06/1983 MODEL ND1100 BONE DENSITY SCANNER MOLSGAARD MEDICAL
K831622 05/20/1983 MORHEL CLOSED URINARY DRAINAGE SET MORHEL MEXICANA
K831520 05/12/1983 MORWEL CANNULA MORWEL CORP.
K831430 05/03/1983 AIR SHIELDS AS-100 MONIORING SYS-AS105 NARCO SCIENTIFIC
K831428 05/03/1983 AS 1740 INTERFACE MODULE NARCO SCIENTIFIC
K831429 05/03/1983 AS 191 ECG TELEMETRY MODULE NARCO SCIENTIFIC
K831460 05/06/1983 AS 30/TCP MODULE NARCO SCIENTIFIC
K831426 05/03/1983 ORTHOPEDIC/NALEBUFF FINGER INSTRUMENTS NEW ENGLAND SURGICAL INSTRUMENT CORP.
K831698 05/25/1983 DISPOSABLE PRESSURE TRANSDUCER#14004195 NORTON PERFORMANCE PLASTICS CORP.
K831587 05/17/1983 TEMP. REPAIR KIT-DUAL LUMEN CATHETER NORTON PERFORMANCE PLASTICS CORP.
K831578 05/17/1983 PHYSIOLOGICAL MONITOR #902 NOVAMETRIX MEDICAL SYSTEMS, INC.
K831617 05/19/1983 DILUENT OMEGA MEDICAL DIAGNOSTICS
K831618 05/19/1983 HEMOGLOBIN REAGENT OMEGA MEDICAL DIAGNOSTICS
K831620 05/19/1983 SODIUM HYPOCHLORITE 3% OMEGA MEDICAL DIAGNOSTICS
K831619 05/19/1983 SODIUM HYPOCHLORITE 7% OMEGA MEDICAL DIAGNOSTICS
K831651 05/23/1983 EVOKED POTENTIAL SYSTEM 2000 OPHTHALMETRIC CORP.
K831523 05/12/1983 BETA SCAN NORMAL CONTROL SOLUTION ORANGE MEDICAL INSTRUMENTS, INC.
K831642 05/23/1983 HEATING BLOCK MICROELISA SYSTEM ORGANON TEKNIKA CORP.
K831658 05/23/1983 MICROELISA COMP ORGANON TEKNIKA CORP.
K831644 05/23/1983 PIPETTE 12 CHANNEL ORGANON TEKNIKA CORP.
K831641 05/23/1983 READER MICROELISA SYSTEM ORGANON TEKNIKA CORP.
K831643 05/23/1983 STRIPREADER MICROELISA SYSTEM ORGANON TEKNIKA CORP.
K831640 05/23/1983 WASHER 6000 MICRO-C LISA SYSTEM ORGANON TEKNIKA CORP.
K831670 05/23/1983 ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO ORTHO DIAGNOSTIC SYSTEMS, INC.
K831500 05/11/1983 TRI-LEVEL TDM CONTROL & I II III ORTHO DIAGNOSTIC SYSTEMS, INC.
K831695 05/25/1983 TEMP. CARDIAC PACING WIRE TME 60/61/65 OSCOR INC.
K831469 05/06/1983 LEGIONELLA CYE AGAR BASE & BCYE SUPPL OXOID U.S.A., INC.
K831445 05/05/1983 INFUSION SETS #'S 124 & 142 PERSONAL PACESETTER SYSTEMS
K831443 05/05/1983 PACELINE PATIENT TRANSMITTER MODEL 324 PACESETTER SYSTEMS
K831444 05/05/1983 SINGLE USE SYRINGE #103 PERSONAL MEDIC PACESETTER SYSTEMS
K831436 05/04/1983 UNIPOLAR ATRIAL J PACING LEAD MODEL 869 PACESETTER SYSTEMS
K831435 05/04/1983 VENTRICULAR PACING LEADS MODELS 865/867 PACESETTER SYSTEMS
K831402 05/02/1983 PRESSURE MONITOR & CONTROL UNIT APC-02A PARKER HANNIFIN CORP.
K831707 05/26/1983 MODIFIED UNSCENTED MENSTRUAL PADS PERSONAL PRODUCTS CO.
K832215 05/26/1983 SCENTED MENSTRUAL PAD PERSONAL PRODUCTS CO.
K831442 05/05/1983 PHADEBAS & PHADEZYM RAST ALLERGEN DISCS PHARMACIA, INC.
K837517 05/13/1983 INFRADIODE INFRARED LAMP PHIMO OF TEXAS, INC.
K837608 05/16/1983 PIP X-RAY PROTECTIVE GLASSES PINNACLE INTL., INC.
K831631 05/20/1983 GASTROSTOMY FEEDING SET PLASCO, INC.
K831650 05/23/1983 ANESTHESIA/RESPIRATORY DISCONNECT - PLASMEDICS, INC.
K831601 05/18/1983 APNEA ALARM FOR ADULT-PEDIATRIC & NEON PLASMEDICS, INC.
K831678 05/23/1983 P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
K831527 05/12/1983 SPINAL FLUID TOTAL PROTEIN CONTROL QUANTIMETRIX CORP.
K831526 05/12/1983 URINE TOTAL PROTEIN CONTROL QUANTIMETRIX CORP.
K831448 05/05/1983 SPIA SYS FOR SOLID PHASE IMMUNOASSAYS R & D SYSTEMS, INC.
K831470 05/06/1983 PTH MR RAMCO LABORATORIES, INC.
K831585 05/17/1983 ALBUMIN REAGENT (BCG REAGENTS APPLICATIONS, INC.
K831419 05/03/1983 RAICHEM LDH-P REAGENT W/SEPARATE START- REAGENTS APPLICATIONS, INC.
K831656 05/23/1983 ARTHROSCOPY KNIVES/PROBES/BENDING TOOL RICHARDS MANUFACTURER CO.
K831721 05/31/1983 RIONET HEARING AID -AND/OR RION RION ACOUSTIC INSTRUMENTS, INC.
K831724 05/31/1983 CHIN (MENTOPLASTY) IMPLANTS S. JACKSON, INC.
K831726 05/31/1983 EYE MUSCLE SLEEVES S. JACKSON, INC.
K831725 05/31/1983 FOIL IN 3 FORMS-NON-STERILE SHEETS S. JACKSON, INC.
K831727 05/31/1983 QUARTER GLOBE CAPS S. JACKSON, INC.
K831723 05/31/1983 SUPRAMID EXTRA SURGICAL MESH S. JACKSON, INC.
K831495 05/10/1983 CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHO SCIENTIFIC PHARMACEUTICALS, INC.
K831528 05/12/1983 MODEL TP THERMISTOR PROBE SCIMED LIFE SYSTEMS, INC.
K831561 05/16/1983 AMYLAST-D TEST SCLAVO, INC.
K831560 05/16/1983 GLUCOSE HEXOKINASE DIAG. KIT SCLAVO, INC.
K831697 05/25/1983 TELECTRONICS MODEL 2401 SEAMED CORP.
K831525 05/12/1983 H-FLU B ELISA TEST SERAGEN DIAGNOSTICS, INC.
K831720 05/31/1983 ARGYLE SILICONE TRACHESTOMY TUBE W/LOW SHERWOOD MEDICAL CO.
K831719 05/31/1983 MONOJET SPS BLOOD COLLECTION TUBE SHERWOOD MEDICAL CO.
K831519 05/12/1983 RPMI-1640 MEDIUM W/L-GLUTAMINE & SIGMA CHEMICAL CO.
K831700 05/24/1983 MULTICHEM ENZYMATIC CHOLESTEROL SYS SIMMLER, INC.
K831621 05/19/1983 FLUORETS STERILE OPHTH. STRIPS SMITH & NEPHEW, INC.
K831454 05/06/1983 LASTOBAND ADHESIVE BANDAGES SMITH & NEPHEW, INC.
K831667 05/23/1983 FEMININE HYGIENE DEVICE SNOW WILLOW CO.
K831562 05/16/1983 SONTEK INFUSION CATHETER SONTEK CORP.
K831506 05/11/1983 DISP. TRANSDUCER W/MONITORING KIT TRANS SORENSEN RESEARCH
K831505 05/11/1983 THORACIC GAUGE #TG-60 -VACUUM REGULATOR SORENSEN RESEARCH
K831579 05/17/1983 GONORRHEA TRANSETTE 1 & 3 SPECTRUM DIAGNOSTIC, INC.
K831497 05/10/1983 SPIROMETRICS BREON 2400 & SMI 2400 SPIROMETRICS, INC.
K831415 05/02/1983 LACTIC DEHYDROGENASE REAGENT SET STERLING BIOCHEMICAL, INC.
K831580 05/17/1983 PARAFFIN INFILTRATION MEDIUM SURGIPATH MEDICAL INDUSTRIES, INC.
K831518 05/12/1983 AUTO CAROUSE/WASH SOLUTION CONCENTRATE SYVA CO.
K831416 05/03/1983 EMIT QST TOBRAMYCIN ASSAY SYVA CO.
K831417 05/03/1983 EMIT QST TOBRAMYCIN CONTROL SYVA CO.
K831632 05/20/1983 MEDICAL RUBBER GLOVES-STERILE-SURGEONS TAGUM RUBBER INDUSTRIES, LTD.
K837499 05/09/1983 AUTOSECTOR TECHNICARE CORP.
K831704 05/26/1983 TECHNICON H6000 SYSTEM CONTROL TECHNICON INSTRUMENTS CORP.
K831800 05/23/1983 TEXAS INTERFACE PRESSURE EVALUATOR-TIPE TEE-KAY APPLIED TECHNOLOGY
K831614 05/19/1983 INSPETOSCOPE TERAYCO INTL., LTD.
K831482 05/09/1983 CLIRANS TAF 120 HOLLOW FIBER DIALYZ. & TERUMO MEDICAL CORP.
K831597 05/17/1983 SERO/TEX RED CELL RF TEST TEXAS IMMUNOLOGY, INC.
K831649 05/23/1983 THERMOMIXER S213-PHOTOANALYZER S263 TEXAS INTL. LABORATORIES, INC.
K831420 05/03/1983 HIP PROSTHESIS -VARIOUS THE OEC GROUP
K831703 05/25/1983 COVERUPS THE UROLOGY GROUP
K831489 05/10/1983 SURGICAL TUBE HOLDER THE UROLOGY GROUP
K831557 05/16/1983 INTRAOPERATIVE AUTOTRANSFUSION SYS THORATEC LABORATORIES CORP.
K831459 05/06/1983 FETAL BLOOD SAMPLING KIT #1560 TRANSIDYNE GENERAL CORP.
K831668 05/23/1983 CONTINU-FLO SOLUTION ADMINISTRATION TRAVENOL LABORATORIES, S.A.
K831534 05/12/1983 PUMPETTE AS8P-INFUSION PUMP TRAVENOL LABORATORIES, S.A.
K831588 05/17/1983 INSTRUMENT GUARD CAPSULE TREACE MEDICAL, INC.
K831590 05/17/1983 T-TUBE INSERTER TREACE MEDICAL, INC.
K831589 05/17/1983 VENT TUBE FORCEPS TREACE MEDICAL, INC.
K831412 05/02/1983 CRM-100 COLOR VIDEO CAMERA UMI, INC.
K831749 05/23/1983 ENDODONTIC BROACH(76EKN) BARBED BROACH UNION BRANCH
K831748 05/23/1983 ENDODONTIC ROOT CANAL PLUGGER FINGER- UNION BRANCH
K831457 05/06/1983 AUTO SUTURE POLY SURGICLIP HEMOSTATIC UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K831734 05/31/1983 AMOXAPINE 8-HYDRO-XYAMOXAPINE UTAK LABORATORIES, INC.
K831738 05/31/1983 CAFFINE TOXICOLOGY CONTROL UTAK LABORATORIES, INC.
K831740 05/31/1983 DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE UTAK LABORATORIES, INC.
K831741 05/31/1983 FLURAZEPAM TOXICOLOGY CONTROL UTAK LABORATORIES, INC.
K831735 05/31/1983 MAPROTILINE UTAK LABORATORIES, INC.
K831739 05/31/1983 PENTOBARBITAL TOXICOLOGY CONTROL UTAK LABORATORIES, INC.
K831736 05/31/1983 TRICYCLIC ANTIDEPRESSANTS UTAK LABORATORIES, INC.
K831737 05/31/1983 TRICYCLIC ANTIDEPRESSNATS VI UTAK LABORATORIES, INC.
K831508 05/11/1983 MALIS CMC-II BIPOLAR COAGULATOR & CUT VALLEY FORGE SCIENTIFIC CORP.
K831554 05/13/1983 NEIN ALLERGEN DISC IN VAST VENTREX TEST VENTREX LABORATORIES, INC.
K831485 05/09/1983 VENTRE/ZYME IGE KIT VENTREX LABORATORIES, INC.
K831666 05/23/1983 SIALOGRAPHY NEEDLE VERTEX MEDICAL CORP.
K831686 05/24/1983 CHLAMYDIA OVERBY MEDIA VIROMED LABORATORIES, INC.
K831684 05/24/1983 CYNOMOLGUS MONKEY KIDNEY CELLS SV5 VIROMED LABORATORIES, INC.
K831681 05/24/1983 HEP-2 CELLS VIROMED LABORATORIES, INC.
K831682 05/24/1983 MCCOY CELLS VIROMED LABORATORIES, INC.
K831679 05/24/1983 MRC-5 CELLS VIROMED LABORATORIES, INC.
K831683 05/24/1983 SF CELLS VIROMED LABORATORIES, INC.
K831685 05/24/1983 SF REFEEDING MEDIA VIROMED LABORATORIES, INC.
K831680 05/24/1983 VERO CELLS VIROMED LABORATORIES, INC.
K831503 05/11/1983 DOWNS ADJUSTABLE FLOW GENERATOR VITAL SIGNS, INC.
K831713 05/27/1983 NON CONDUCTIVE ANESTHESIA FACEMASK VITAL SIGNS, INC.
K831687 05/24/1983 WAKO CHOLESTEROL CII WAKO CHEMICALS, USA, INC.
K831688 05/24/1983 WAKO LDH CII TEST WAKO CHEMICALS, USA, INC.
K831639 05/23/1983 WAKO R-GTP C-TEST WAKO CHEMICALS, USA, INC.
K831535 05/13/1983 E.P.T. PLUS TM WARNER-LAMBERT CO.
K831492 05/10/1983 YESONA PLASTER OF PARIS BANDAGE WATSON PHILLIPS Y CIA. SUCS., S.A. DE C.V.
K831709 05/26/1983 AUDIOSCOPE #23000 W/71123 CHARGING STAND WELCH ALLYN, INC.
K831593 05/17/1983 MAXI SHIELDS WEYERHAEUSER CO.
K831477 05/09/1983 DEMAND ANALYZER SYSTEM WORTHINGTON DIAGNOSTIC SYSTEMS
K831407 05/02/1983 CARDIAC OUTPUT COMPUTER ZIEHM INTERNATIONAL, INC.


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