FDA 510(k) Decisions During June, 1977  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K770868 06/27/1977 CATHETER, POLYURETHANE, W/STYLET ABBOTT LABORATORIES
K770843 06/14/1977 IV PUMP FILTERSET, UNIVERSAL ABBOTT LABORATORIES
K770743 06/24/1977 SOLUSET FOR IV FAT EMULSION ABBOTT LABORATORIES
K770596 06/20/1977 CONNECTORS ABCO DEALERS, INC.
K770865 06/14/1977 MONITOR, PACEMAKER ADCOR ELECTRONICS, INC.
K770861 06/17/1977 SURGICAL COLDLIGHT, AX8 AFFILIATED HOSPITAL PRODUCTS, INC.
K770747 06/01/1977 REAGENT SET, CHOLESTEROL, CAT NO. 4024 AMERICAN MONITOR CORP.
K770504 06/27/1977 REAGENT SYSTEM AMERICAN MONITOR CORP.
K771045 06/22/1977 BLADES, SCALPEL AMERICAN SAFETY RAZOR CO.
K770779 06/17/1977 PHENYTOIN RIA KIT AMERSHAM CORP.
K770989 06/29/1977 API 50 E ANALYTICAL PRODUCTS, INC.
K770926 06/17/1977 SUSPENSION SALINE, API 20E ANALYTICAL PRODUCTS, INC.
K771021 06/14/1977 AUTO-CLIP AXIOM MEDICAL, INC.
K770731 06/24/1977 EAGENT SYSTEM, CORTISOL, ARIA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770655 06/24/1977 LATELET DETERMIBATION KIT, UL 800 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770732 06/22/1977 REAGENT SYSTEM, PROGESTERONE, ARIA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770733 06/24/1977 REAGENT SYSTEM, THYROXINE, ARIA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770465 06/02/1977 RIA-120 AND ESTRIOL REAGENT SYSTEM BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770654 06/24/1977 UN, UV DELTA TEST ASSAY BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770570 06/08/1977 CALCIUM/MAGNESIUM ANALYZER BECKMAN INSTRUMENTS, INC.
K771023 06/24/1977 ANALOG QUANTIFIER MODEL AQ-100 BIO-FEEDBACK SYSTEMS, INC.
K771047 06/27/1977 QUANTA-MATE VITAMIN B-12/FOLATE RA BIO-RAD
K770648 06/14/1977 QUANTIMUNE T-3 RIA BIO-RAD
K770555 06/03/1977 CPK ISOENZYME CONTROL BIO-REAGENTS & DIAGNOSTICS, INC.
K770406 06/02/1977 TECHNICON SMA & AAII SYSTEMS BOEHRINGER LABORATORIES
K770921 06/02/1977 SPHYGMOMANOMETER, ELECTRONIC BRISTOLINE, INC.
K770939 06/03/1977 URINE TESTER, MODEL 701 BROTHER SCIENTIFIC PRODUCTS, INC.
K770423 06/03/1977 URINE TESTER, MODEL NO. 707 BROTHER SCIENTIFIC PRODUCTS, INC.
K770881 06/20/1977 GENERATOR, PULSE, BIPOLAR 3608 CARDIAC PACEMAKERS, INC.
K770880 06/20/1977 GENERATOR, PULSE, UNIPOLAR, #508 CARDIAC PACEMAKERS, INC.
K770988 06/14/1977 FOAM ECG ELECTRODE, 2060 AND 2061 CARDIO-DYNAMICS LABORATORIES, INC.
K770802 06/27/1977 MARKERS, STAINLESS STEEL CARDIO-SURGICAL, INC.
K770969 06/24/1977 CLEV-DENT COLHS ELECTROSURG, MOLEL TR-5 CAVITRON CORP.
K770736 06/02/1977 MONITOR, PATIENT, MODEL PM-20N CAVITRON CORP.
K770968 06/08/1977 MONITOR, PATIENT, MODEL PM-I0N CAVITRON CORP.
K770866 06/03/1977 RABBIT COMPLEMENT CEDARLAKE LABS LTD.
K770702 06/17/1977 IN VITRO FERRITIN RIA TEST CLINICAL ASSAYS, INC.
K771117 06/23/1977 CENTRIA CORTISOL RIA CLINICAL DIAGNOSTICS, INC.
K770867 06/14/1977 DIALYZER, FIBER, HOLLOW COBE LABORATORIES, INC.
K771026 06/20/1977 HUANG VEIN HOLDER, #21-8011 CODMAN & SHURTLEFF, INC.
K770498 06/20/1977 PRESERVE LUBRICANT CODE NO. 43=4035 CODMAN & SHURTLEFF, INC.
K770413 06/24/1977 CUSHIONS, DENTURE ADHESIVE, ALL-DAY COMBE, INC.
K771103 06/24/1977 URETHRAL TRAY W/CATHETER, 7750 CONCORD LABORATORIES, INC.
K771104 06/24/1977 URETHRAL TRAY W/OUT CAHTETER, 7650 CONCORD LABORATORIES, INC.
K770523 06/20/1977 NEEDLE, BIOPSY, BOYD, LUNG COOK, INC.
K770913 06/01/1977 UROLOGICAL BIOPSY BRUSH SET COOK, INC.
K770951 06/20/1977 CARDIAC PACERS W/NARROW PULSE WIDTH CORDIS CORP.
K770752 06/17/1977 REAGENT, CHLORIDE, COULTER COULTER ELECTRONICS, INC.
K770787 06/17/1977 RELAXATION COURSE MOLEL 1000 CYBERNETIC MEDICAL, INC.
K770918 06/17/1977 LIQUI SOL T4 RIA TEST KIT DAMON CORP.
K771014 06/14/1977 TS-100 TEST SYSTEM DELTA MEDICAL INDUSTRIES
K771006 06/17/1977 MODIFIED PODIATRY PRODUCTS DENTRONIX INC.
K771005 06/17/1977 NEW PODIATRY PRODUCTS DENTRONIX INC.
K771072 06/27/1977 INSERTEO, META.-PHAL.&THUMB CARPO-META DEPUY, INC.
K770862 06/27/1977 BLACK LAMPS,F72T12/BL/HO DERMATRON CORP.
K770896 06/03/1977 COLPOSCOPE MODEL II DYNATECH CRYOMEDICAL CO.
K770915 06/14/1977 CLASP RIA KIT, HTSH E. R. SQUIBB & SONS, INC.
K770919 06/22/1977 PHENOBARBITAL ANALYTICAL TEST PACKS E.I. DUPONT DE NEMOURS & CO., INC.
K771003 06/17/1977 LIEBERMAN POLACK DOUBLE CORNEAL FORCEPS EDWARD WECK, INC.
K771046 06/22/1977 VENA CAVA UMBRELLA FILTER, MODEL 7321 EDWARDS LABORATORIES
K770941 06/02/1977 APPLIC SYSTEM ACTIVATOR, ESPE ESPE GMBH (US)
K770931 06/03/1977 APPLIC SYSTEM APPLIER, ESPE ESPE GMBH (US)
K770922 06/01/1977 DENTAL RESTORATIVE IN CAPSULES ESPE GMBH (US)
K770923 06/01/1977 ESPETEMP (TEMP. CEMENT) ESPE GMBH (US)
K770872 06/01/1977 IMPRESSION MATERIAL, ALGINATE ESPE GMBH (US)
K770990 06/20/1977 DENTAL PLAQUE DISCLOSING AGENT EVIDENT DENTAL CO. LTD.
K770911 06/27/1977 MEDISHIELD JORDON LIFTING FRAME FRASER SWEATMAN, INC.
K770740 06/22/1977 RADIOASSAY TUBES & RADIOASSAY TUBE CAPS G.D. SEARLE AND CO.
K770765 06/24/1977 REAGENT SET, RENORPACE G.D. SEARLE AND CO.
K770737 06/22/1977 REAGENT SET, T-4, CPB G.D. SEARLE AND CO.
K770738 06/22/1977 REAGENT, T-3 UPTAKE G.D. SEARLE AND CO.
K770739 06/22/1977 SERUM SET, THYROID CONTROL G.D. SEARLE AND CO.
K770858 06/14/1977 DIALYZER, ULTRADIFFUSER, DISPOSABLE GAMBRO, INC.
K771051 06/24/1977 C-ARM X-RAY SYSTEM GENERAL ELECTRIC CO.
K770550 06/17/1977 ATYPIA PROFILE MONITOR GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K770869 06/02/1977 ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K770701 06/03/1977 HEMATRAK MODEL 125 GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K770957 06/14/1977 PEDIATRIC BLOOD CULTURE BOTTLES GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K770840 06/08/1977 PRE-REDUCED ANAEROBIC MEDIA GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K770839 06/08/1977 AQUAMATIC K-77 GORMAN RUPP INDUSTRIES
K770875 06/03/1977 IMPROVED THAYER MARTIN (JEMBEC) GRANITE DIAGNOSTICS, INC.
K770874 06/08/1977 IMPROVED THAYER MARTIN (PLATE) GRANITE DIAGNOSTICS, INC.
K770876 06/03/1977 IMPROVED TRANSGROW GRANITE DIAGNOSTICS, INC.
K771064 06/24/1977 ANA TEST GULL LABORATORIES, INC.
K770613 06/17/1977 LDH ULTRAZYME PLUS HARLECO DIAGNOSTICS
K770826 06/28/1977 POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE HOWMEDICA CORP.
K770771 06/02/1977 AEROSOL EFFUSION SYSTEM #1740 HUDSON OXYGEN THERAPY SALES CO.
K770643 06/24/1977 CREATININE TEST, SUPER SEVENTEEN HYCEL, INC.
K770748 06/01/1977 TEST, FERROZINE IRON & IRON BINDING HYCEL, INC.
K771037 06/27/1977 THERMOMETER, SINGLE USE, STRIP, TEMPADOT INFO-CHEM
K770894 06/20/1977 NEURO-SORB PATTIES INSTRANETICS, INC.
K770660 06/24/1977 ANALYZER, CENTRIFUGAL, IL MULTISTAT III INSTRUMENTATION LABORATORY CO.
K770228 06/27/1977 AQUEOUS PH/BLOOD GAS CONTROLS INSTRUMENTATION LABORATORY CO.
K770645 06/24/1977 SPECTROPHOTOMETER, MODEL 751 INSTRUMENTATION LABORATORY CO.
K770705 06/02/1977 CARDIAC ACQUISITION SYSTEM, ICR 2001 INSTRUMENTS FOR CARDIAC RESEARCH
K770412 06/17/1977 PROPHALACTICS JAMAR HEALTH PRODUCTS
K770533 06/07/1977 BAND-AID BRAND ADHES. BAND.-SHEER STRIPS JOHNSON & JOHNSON PROFESSIONALS, INC.
K770410 06/09/1977 BANDAGE COMPRESS 2", 3", 4" JOHNSON & JOHNSON PROFESSIONALS, INC.
K770929 06/02/1977 BANDAGES, SPEC. X-TRA HARD OR PLASTER JOHNSON & JOHNSON PROFESSIONALS, INC.
K770932 06/03/1977 GERAMCO LOW TEMP GLAZE JOHNSON & JOHNSON PROFESSIONALS, INC.
K770362 06/15/1977 TAPE, DERMICEL, CLOTH JOHNSON & JOHNSON PROFESSIONALS, INC.
K770749 06/20/1977 TOOTHBRUSH, REACH JOHNSON & JOHNSON PROFESSIONALS, INC.
K770964 06/24/1977 GOAT ANTISERUM COMPLEMENT C3 NEPHEL. KALLESTAD LABORATORIES, INC.
K770962 06/24/1977 GOAT ANTISERUM IGA NEPHELOMETRIC KALLESTAD LABORATORIES, INC.
K770961 06/24/1977 GOAT ANTISERUM IGG NEPHELOMETRIC KALLESTAD LABORATORIES, INC.
K770963 06/24/1977 GOAT ANTISERUM IGM NEPHELOMHTRIC KALLESTAD LABORATORIES, INC.
K770965 06/22/1977 HUMAN REFERENCE SERUM KALLESTAD LABORATORIES, INC.
K770520 06/03/1977 RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3 KALLESTAD LABORATORIES, INC.
K770892 06/14/1977 TSH RADIOIMMUNOASSAY KALLESTAD LABORATORIES, INC.
K770977 06/14/1977 CARDIOVASCULAR SPRING GUIDES LAKE REGION MFG., INC.
K770975 06/08/1977 ANTI-CONVULSANT DRUG CONTROL LEDERLE LABORATORIES
K771076 06/24/1977 ORTHODONTIC BRACKET ADHESIVE LEE PHARMACEUTICALS
K771077 06/24/1977 ULTRAVIOLET RAD-EMITTING LAMP LEE PHARMACEUTICALS
K770897 06/03/1977 URODYNAMIC INSTRUMENTS LIFE-TECH INSTRUMENTS, INC.
K770796 06/22/1977 SKIN SCRUB PREP SET LUKENS CORP.
K770799 06/22/1977 TRAY, IRRIGATION, STERILE, BASIC LUKENS CORP.
K770955 06/17/1977 MIRACLELENS M.R.M. OPTICS, INC.
K770960 06/14/1977 HEARING AID, SERIES R MAICO HEARING INSTRUMENTS, INC.
K770564 06/03/1977 URIC ACID TEST KIT MALLINCKRODT CRITICAL CARE
K770649 06/02/1977 VAC-RITE MEDICAL DEVELOPMENT CO.
K770699 06/14/1977 NEEDLE SET, A-V FISTULA MEDICAL DISPOSABLES INTL., INC.
K770945 06/29/1977 POUCH, TYVEK-POLYMYLON MEDICAL DISPOSABLES INTL., INC.
K770888 06/03/1977 POMERANTZEFF EQUATOR PLUS CAMERA MEDICAL INSTRUMENT RESEARCH ASSOC., INC.
K770878 06/01/1977 SIGNAL PROCESSOR/AVERAGER MODEL 7S11 MEDICAL SYSTEMS CORP.
K770641 06/24/1977 MINI-CONER TM MEDICAL TESTING SYSTEM, INC.
K770832 06/03/1977 PORTASCOPE II MENNEN GREATBATCH ELECTONICS
K770745 06/23/1977 PANEL, GNF, MICRO-ID MICRO-MEDIA SYSTEMS, INC.
K770746 06/23/1977 PANEL, IDENTIFICATION, STREP, MICRO-ID MICRO-MEDIA SYSTEMS, INC.
K770925 06/08/1977 IMPROVED THAYER-MARTIN MEDIUM MICRO-TECH DIAGNOSTIC, INC.
K770687 06/14/1977 MEASLESVIRUS FLOURE. CONJUGATED ANTISERU MICROBIOLOGICAL ASSOC.
K770703 06/14/1977 FILTER UNIT, SINGLE USE MILLIPORE CORP.
K771065 06/24/1977 DYLADE, MODEL DS MILTON ROY CO. ANALYTICAL
K770967 06/20/1977 SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE NATIONAL PATENT DEVELOPMENT CORP.
K770903 06/29/1977 STERILE CONTINER, X-RAY CASSETTE HOLDER NORTH SHORE ORTHOPAEDIC GROUP, S.C.
K771095 06/24/1977 "J" HOOK HEADGEAR NORTHWEST ORTHODONTICS, INC.
K770707 06/03/1977 TYGON PAC-MONITORING LINES & FLUID ADMIN NORTON PERFORMANCE PLASTICS CORP.
K770916 06/17/1977 TYGON PAC-MONITORING LINES & FLUID ADMIN NORTON PERFORMANCE PLASTICS CORP.
K770708 06/08/1977 TYGON PAC-STOPCOCKS NORTON PERFORMANCE PLASTICS CORP.
K770601 06/14/1977 ANALYZER, SODIUM/POTASSIUM NOVA L NOVA BIOMEDICAL CORP.
K770995 06/27/1977 AEROSOL MASK OHIO MEDICAL PRODUCTS
K770996 06/29/1977 OXYGEN CANNULA OHIO MEDICAL PRODUCTS
K771082 06/24/1977 DELTASCAN 2000 SERIES OHIO NUCLEAR, INC.
K771038 06/27/1977 THERMOMETER, SINGLE USE, STRIP, TEMPADOT ORGANON, INC.
K770605 06/15/1977 TUBES, HYDROLYSIS, CALIBRATED ORGANON, INC.
K771109 06/27/1977 ORTHOPEDIC SOFT GOODS ORTHOPEDIC SYSTEMS, INC.
K771020 06/17/1977 SPINAL SURGERY FRAME ORTHOPEDIC SYSTEMS, INC.
K770987 06/14/1977 NERVE STIMULATOR, MOLEL NO. FB-800 OUTPUT, INC.
K771011 06/20/1977 ARTICULATING PAPER PARKER LABORATORIES, INC.
K770639 06/24/1977 DETECTOR, IR, MODEL GC-33 PEOKIN-ELMER CORP.
K770638 06/24/1977 DETECTOR, UV, MOLEL GC-55 PEOKIN-ELMER CORP.
K771012 06/24/1977 ASSURE DEODORANT TAMPONS PERSONAL PRODUCTS CO.
K770833 06/08/1977 FLUORETEC-M PFIZER, INC.
K771078 06/27/1977 PHADEBAS T3 U TEST PHARMACIA, INC.
K771029 06/22/1977 MULTISONIC (DELUXE) CODE TDM QUALITONE
K771069 06/24/1977 MULTISONIC (SUPER) CODE TSM QUALITONE
K771019 06/14/1977 LUNG-MECHANICS MONITOR RESEARCH DEVELOPMENT CORP.
K770658 06/17/1977 EXERCISER, LEG, LOWER EXTREMITY ROBERT R. MOORE
K770958 06/14/1977 BANDAGE, UNIPRESS, CLARION SHERWOOD MEDICAL INDUSTRIES
K771054 06/29/1977 BLOOD COLLECTION TUBE, BLUE SHERWOOD MEDICAL INDUSTRIES
K771053 06/29/1977 BLOOD COLLECTION TUBE, GRAY SHERWOOD MEDICAL INDUSTRIES
K771056 06/29/1977 BLOOD COLLECTION TUBE, GREEN SHERWOOD MEDICAL INDUSTRIES
K771052 06/27/1977 BLOOD COLLECTION TUBE, LAVENDER SHERWOOD MEDICAL INDUSTRIES
K771055 06/29/1977 BLOOD COLLECTION TUBE, RED SHERWOOD MEDICAL INDUSTRIES
K771017 06/14/1977 CITADEL CPAP ACCESSORY KIT SHERWOOD MEDICAL INDUSTRIES
K770920 06/24/1977 THORACIC DRAINAGE SET, ARGYLE DUAL SHERWOOD MEDICAL INDUSTRIES
K770577 06/17/1977 DETER. OF PHOSPHOHEXOSE ISOMERASE SIGMA CHEMICAL CO.
K770495 06/08/1977 QUANTI. COLORI. DET. OF SERUM IRON SIGMA CHEMICAL CO.
K770519 06/03/1977 REAGENT SYSTEM 153-UV SIGMA CHEMICAL CO.
K770483 06/08/1977 CHOLESTEROL REAGENT SMITH KLINE DIAGNOSTICS, INC.
K771040 06/29/1977 INTRODUCER, CAT. #INT-07FR. SORENSEN RESEARCH
K770848 06/08/1977 DAILY-WEIGHT SR INSTRUMENTS, INC.
K770847 06/08/1977 PORTA-SCALE SR INSTRUMENTS, INC.
K771030 06/27/1977 FLEXION MITTENS STAT MEDICAL CORP.
K771031 06/27/1977 STROKE SLING STAT MEDICAL CORP.
K770998 06/02/1977 CHOLESTEROL REAGENT SET THE DOW CHEMICAL CO.
K770940 06/22/1977 TOTAL THYROXINE (RIA) REAGENT SET THE DOW CHEMICAL CO.
K770949 06/02/1977 COMPUTER ECG TELE. TRANSMISSION TERMINAL THE OKUN CO.
K770640 06/24/1977 GRAPHITE ATOMIZER, HGA-76B THE PERKIN-ELMER CORP.
K770637 06/23/1977 MERCURY/HYDRIDE SYSTEM MHS-1 THE PERKIN-ELMER CORP.
K770704 06/24/1977 GLOVES, SURGEONS, LATEX TILLOTSON RUBBER CO., INC.
K770912 06/29/1977 TIPROTECTOR TOWER PRODUCTS, INC.
K770763 06/08/1977 BURETTE SET, 2C0132 TRAVENOL LABORATORIES, S.A.
K770671 06/27/1977 CALCULATOR, ENZYME, TURNER TURNER ASSOC.
K770460 06/02/1977 CENTRIFI CHEM CALCIUM REAGENT UNION CARBIDE CORP.
K770959 06/14/1977 BOUGIE, FILIFORM, JACKSON V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K770863 06/14/1977 FLU VEN 0160 VENOSPITAL, INC.
K770864 06/24/1977 HEMODIALYSIS FISTULA SET VENOSPITAL, INC.
K770938 06/28/1977 TINNITUS AID, MODEL S244 VICON INSTRUMENT CO.
K770446 06/15/1977 SPONGES, LAPAROTOMY WALPAK CO.
K770906 06/01/1977 ANOSCOPE, OPTIC, FIBER WELCH ALLYN, INC.
K771081 06/24/1977 LITECAST CERAMIC WILLIAMS GOLD REFINING CO., INC.
K770470 06/02/1977 WORTHINGTON BUN WORTHINGTON BIOCHEMICAL CORP.
K770997 06/20/1977 PRO-CARE YOUNG DENTAL MANUFACTURING CO 1, LLC.


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