FDA 510(k) Decisions During April, 1977  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K770709 04/27/1977 PROBE, TEMPERATURE, SYSTEM, SARNS 3M HEALTH CARE, SARNS
K770518 04/29/1977 PIGGYBACK VENOSET W/0.22 FILTER ABBOTT LABORATORIES
K770201 04/05/1977 T3 RIA (PEG) DIAGNOSTIC KIT ABBOTT LABORATORIES
K770474 04/28/1977 THYROSCREEN TM T4 DIAGNOSTIC KIT ABBOTT LABORATORIES
K770513 04/29/1977 MASK, SURGICAL, DISP ACME AUTOMATIC DISPOSABLE
K770414 04/15/1977 PROBE RETRACTOR, PART #S-2L8-6 ACME UNITED CORP.
K770481 04/29/1977 SHEAR, PLASTIC HANDLE UTILITY S-475-7 ACME UNITED CORP.
K770359 04/08/1977 IMPLANTING OF POLYACRYLIC FIBERS ALLAN V. MARSE
K770754 04/28/1977 DUODENOSCOPE, MOLEL TX-6 AMERICAN CYSTOCOPE MAKERS, INC.
K770674 04/26/1977 CURETTE, UTERINE, VACUUM ASPIRATING AMERICAN HOSPITAL SUPPLY CORP.
K770381 04/05/1977 ISOLATION KIT AMERICAN HOSPITAL SUPPLY CORP.
K770479 04/29/1977 LACERATION KIT AMERICAN HOSPITAL SUPPLY CORP.
K770238 04/05/1977 OVERDOSE KIT AMERICAN HOSPITAL SUPPLY CORP.
K770486 04/29/1977 SHEET KIT, STRETCHER, DISPOSABLE AMERICAN HOSPITAL SUPPLY CORP.
K770329 04/05/1977 WOMB PREP KIT AMERICAN HOSPITAL SUPPLY CORP.
K770528 04/29/1977 NEEDLE, MEMBRANE AMERICAN VIGGO
K770398 04/06/1977 MINICON AMICON, INC.
K770385 04/08/1977 LATELET DETERMIN. KIT, CAT NO. 2521 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770401 04/26/1977 LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770384 04/08/1977 MNITROL HEMOTOL. REF. AND CONTROL BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770400 04/26/1977 REAGENT, AMYLASE LIPASE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770602 04/15/1977 VALVE, ASCITES, LAVEEN BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770572 04/15/1977 DP-5000 DATA REDUCTION SYSTEM BECKMAN INSTRUMENTS, INC.
K770352 04/08/1977 METER, IV PH, MODEL EXPANDOMATIC BECKMAN INSTRUMENTS, INC.
K770351 04/05/1977 METER, IV PH, MODEL ZEROMATIC BECKMAN INSTRUMENTS, INC.
K770347 04/15/1977 METER, PH, DIGITAL, MODEL 3560 BECKMAN INSTRUMENTS, INC.
K770663 04/26/1977 FEEDBACK EMG SYSTEM, MODEL PE-L00 BIO-FEEDBACK SYSTEMS, INC.
K770253 04/05/1977 MICROFILTRATION SET MF10 BIOTEST-SERUM-INSTITUT
K770692 04/26/1977 MONITOR, FETAL, NO. L04-1100 BRATTLE INSTRUMENT CORP.
K770581 04/19/1977 CORRUGATED TUBING, 770 & 771 C.D. & F. CORP.
K770646 04/28/1977 ELECTROSURGICAL PATIENT GROUNDING PAD C.R. BARD, INC.
K770514 04/07/1977 STERILIZER WRAP C.R. BARD, INC.
K770715 04/25/1977 GENERATOR, PULSE, BIPOLAR, MODEL #604 CARDIAC PACEMAKERS, INC.
K770716 04/26/1977 GENERATOR, PULSE, UNIPOLAR, MODEL #504 CARDIAC PACEMAKERS, INC.
K770536 04/29/1977 STEAM STERILIZER, 3000 CASTLE CO.
K770372 04/05/1977 STERILIZER, STEAM, CASTLE 3000 CASTLE CO.
K770713 04/27/1977 MONITOR, PATIENT, RESP. CARBON DIOXIDE CAVITRON CORP.
K770532 04/05/1977 PC-30 PULMONARY COMPUTER CAVITRON CORP.
K770433 04/15/1977 Q-TIPS CHESEBROUGH-POND'S U.S.A. CO.
K770233 04/05/1977 STERILE SUCTION CATHETER W/CONTROL CHESIRE LABORATORIES
K770480 04/06/1977 IN VITRO T-3 UPTAKE TEST CLINICAL ASSAYS, INC.
K770057 04/05/1977 NDNA IMMUNOPATH FLUORO-KIT CLINICAL SCIENCES, INC.
K770578 04/15/1977 PARALLEL PLATE DIALYZER COBE LABORATORIES, INC.
K770672 04/15/1977 COLLECTOR, SANI-CATCH, NO. 1010 CONCORD LABORATORIES, INC.
K770673 04/15/1977 COLLECTOR, SANI-CATCH, NO. 1014 CONCORD LABORATORIES, INC.
K770361 04/05/1977 TRAY, BLOOD GAS, CAT. NO. 4010 CONCORD LABORATORIES, INC.
K770535 04/15/1977 C-DAK 3500 CORDIS CORP.
K770662 04/15/1977 VIEWER, FLUOROMETIC, MODEL 721 CORNING MEDICAL & SCIENTIFIC
K770742 04/28/1977 CUTTER CAST 7 CUTTER LABORATORIES, INC.
K770619 04/07/1977 EXERCISOR, RESPIRATORY CUTTER LABORATORIES, INC.
K770468 04/05/1977 UNIPOLAR LEAD CONFIGURATION CONDUCTOR DAIG CORP.
K770546 04/26/1977 BLOOD RESERVOIR DELTA MEDICAL INDUSTRIES
K770599 04/05/1977 NUVA-LITE II PHOTO-CURE UNIT DENTSPLY INTL.
K770759 04/29/1977 HOOK HOLLER DEPUY, INC.
K770614 04/07/1977 MONITOR, GAS MANIFOLD DYNATECH CRYOMEDICAL CO.
K770363 04/08/1977 "ACA" AMMONIA ANALYTICAL TEST PACK E.I. DUPONT DE NEMOURS & CO., INC.
K770364 04/15/1977 "ACA" LIPASE ANALYTICAL TEST PACK E.I. DUPONT DE NEMOURS & CO., INC.
K770574 04/05/1977 CRONEX QUANTA III INTENSIFYING SCREENS E.I. DUPONT DE NEMOURS & CO., INC.
K770651 04/14/1977 RETRACTORS & HOOKS, ABRAMSON EDWARD WECK, INC.
K770656 04/26/1977 GENERATOR, PULSE, CARDIAC 20U EDWARDS PACEMAKER SYSTEMS
K770657 04/26/1977 GENERATOR, PULSE, CARDIAC 2LU EDWARDS PACEMAKER SYSTEMS
K770590 04/14/1977 SURGI-KIT ETHOX CORP.
K770567 04/14/1977 LIGHT, EXAMINATION, MEDICAL (MEL) FIBER OPTICS ENGINEERING, INC.
K770568 04/14/1977 SURGICAL ILLUMINATOR (SIL) FIBER OPTICS ENGINEERING, INC.
K770691 04/28/1977 GAMBRO VENOUS BLOOD LINE GAMBRO, INC.
K770494 04/15/1977 BLOOD GAS ANALYZER-CALIBRATION GAS GARDNER CRYOGENICS
K770179 04/05/1977 CARDIAC CATHETERIZATION LAB MONITOR SYS GENERAL ELECTRIC CO.
K770683 04/26/1977 BOTTLE, BLOOD CULTURE, BI-PHASIC GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K770650 04/15/1977 PRE-DUCED CULTURE MEDIA GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K770623 04/08/1977 CONDUCTIVE CREAM-500 GRAPHIC CONTROLS CORP.
K770622 04/07/1977 CONDUCTIVITY GEL W/POTASSIUM CHLORIDE GRAPHIC CONTROLS CORP.
K770215 04/15/1977 ACTIVATOR LIGHT GTE SYLVANIA, INC.
K770086 04/18/1977 SANAR HEALTH IMPROVEMENT ASSOC.
K770615 04/07/1977 1304A X-Y DISPLAY INTRODUCTION HEWLETT-PACKARD CO.
K770558 04/05/1977 ISODYNE HMW INDUSTRIES
K770467 04/27/1977 IN VITRO DIAGNOSTIC TEST HOFFMANN-LA ROCHE, INC.
K770439 04/15/1977 STOMA BAG W/SKIN BARRIER SEAL RING HOLLISTER, INC.
K770393 04/26/1977 PROPANE, HIGH PURITY, INSTRUMENT GRADE HYCEL, INC.
K770548 04/15/1977 IMMUNOPLATE III RADIO IMMUNODIFFUSION HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K761008 04/06/1977 LYMPHOCYTE TYPING, NEGATIVE CONTROL HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K761009 04/06/1977 LYMPHOCYTE TYPING, POSITIVE CONTROL HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K770010 04/18/1977 Q-PAK CHEMISTRY RADIORECEPTOR CONTROL A HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K770011 04/18/1977 Q-PAK CHEMISTRY RADIORECEPTOR CONTROL B HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K770012 04/18/1977 Q-PAK CHEMISTRY RADIORECEPTOR CONTROL C HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K770636 04/15/1977 TABLE, EXAM & MANUPULATION I E INDUSTRIES
K770315 04/05/1977 BUN, ENZYMATIC ICN PHARMACEUTICALS, INC.
K770312 04/05/1977 CHEMISTRY CONTROL, ABNORMAL ICN PHARMACEUTICALS, INC.
K770310 04/05/1977 CHEMISTRY CONTROL, NORMAL ICN PHARMACEUTICALS, INC.
K770319 04/05/1977 REAGENT CPK, ENZYME ICN PHARMACEUTICALS, INC.
K770318 04/05/1977 REAGENT GOT, ENZYME ICN PHARMACEUTICALS, INC.
K770313 04/05/1977 REAGENT LDH-L, ENZYME ICN PHARMACEUTICALS, INC.
K770459 04/29/1977 URIC ACID PROCEDURE, TEKPOINT DIRECT ICN PHARMACEUTICALS, INC.
K770634 04/08/1977 ADAPTER BE 105-101 & 125-101 INSTRUMENTATION INDUSTRIES, INC.
K770632 04/08/1977 GAS COLLHCTOR BE 155(155-2-3,154-4) INSTRUMENTATION INDUSTRIES, INC.
K761225 04/07/1977 LOW LEVEL HUMAN ALBUMIN TEST KITS INTL. DIAGNOSTIC TECHNOLOGY
K761224 04/07/1977 ULTRA LOW LEVEL IMMUNOGLOBULIN G INTL. DIAGNOSTIC TECHNOLOGY
K770331 04/20/1977 DIALYSIS, JET SYSTEM JANNECK ENT. OF TEXAS
K770725 04/26/1977 STIMULATOR, MUSCLE, MODEL 107 JAYTRONICS, INC.
K770419 04/05/1977 CENTURION JOHNSON & JOHNSON PROFESSIONALS, INC.
K770719 04/26/1977 IMMUNOELECTROFILM KIH KALLESTAD LABORATORIES, INC.
K770566 04/27/1977 IMMUNOELECTROPHORESIS PROFILE KIT KALLESTAD LABORATORIES, INC.
K770718 04/26/1977 STAIN, R-250, COOMASSIE BRILLIANT BLUE KALLESTAD LABORATORIES, INC.
K770417 04/15/1977 ANIMATOR KDK MEDICAL PRODUCTS
K770670 04/28/1977 FLOR. CONJUG. HUMAN FAB FRAGMENT KENT LABORATORIES, INC.
K770668 04/28/1977 FLUORESCEIN CONJUGATED ANTISERUM KENT LABORATORIES, INC.
K770669 04/28/1977 RHODAMINE-CONJUGATED ANTISERUM KENT LABORATORIES, INC.
K770307 04/05/1977 MICRO/PETTOR, SMI LEDERLE LABORATORIES
K770675 04/26/1977 COMPUTER, CARDIAC OUTPUT, MODEL KM275 LEXINGTON INSTRUMENTS
K770415 04/07/1977 HUMIDIFIER, DISPOSABLE M.G. HUMIDIFIERS, INC.
K770436 04/06/1977 EXERCISER, EXTENSOR WAND MADDAK, INC.
K770616 04/08/1977 AUDIOMETER, MA29, PURE TONE AIR CONDUCT. MAICO HEARING INSTRUMENTS, INC.
K770617 04/07/1977 AUDIOMETER, MA30, AIR & BONE CONDUCTION MAICO HEARING INSTRUMENTS, INC.
K770618 04/08/1977 AUDIOMETER, MA31 MAICO HEARING INSTRUMENTS, INC.
K770714 04/27/1977 CATHETER, ARTERIAL EMBOLECTOMY MALLINCKRODT CRITICAL CARE
K770604 04/06/1977 RIA-DAC TM HTSH KIH MALLINCKRODT CRITICAL CARE
K770665 04/15/1977 VALVE, PRESSURE, DEMAND MCGAW RESPIRATORY THERAPY
K770482 04/15/1977 CATHETER, SINGLE PUNCTURE "Y" MDL MEDICAL DEVICE LABORATORIES, INC.
K770661 04/26/1977 GENERATOR, PULSE, IMPLANTABLE MED TELECTRONICS LTD.
K770507 04/07/1977 PULSE GENERATOR, LITKICRON MODEL 3-70H MEDCOR, INC.
K770728 04/28/1977 INTRAOCULAR LENS MILTON ROY CO. ANALYTICAL
K770727 04/26/1977 MANIPULATOR & INJECTOR, UTERINE NATIONAL CATHETER CO. DIV. MALLINCKRODT
K770642 04/15/1977 SYRINGE, ENDODONTIC W/NOTCHED TIP NEEDLE NATIONAL PATENT DEVELOPMENT CORP.
K770597 04/28/1977 DASP TM ANTI-RABBIT ORGANON, INC.
K770684 04/26/1977 CROWN, ACRYLIC, CORAL BRAND, PREFORMED PARKER LABORATORIES, INC.
K770685 04/26/1977 LIGHT, EXAMINING, DENTAL, ULTRA VIOLET PARKER LABORATORIES, INC.
K770499 04/29/1977 PATIENT TURNING AND REPOSITIONING G DEV. PATIENT HEALTHGUARDS CORP.
K770425 04/15/1977 NEEDLES, STERILE, AIRWAY PFIZER PHARMACEUTICALS
K770322 04/05/1977 PHALDEBAS DIGOXIN RIA PHARMACIA, INC.
K770598 04/05/1977 ENDODONTIC INSTRUMENTS, R&R CUTWELL RANSOM AND RANDOLPH
K770409 04/15/1977 STERI-STOR TM RESEARCH SURGICAL SYSTEMS
K770710 04/26/1977 NEEDLE, SPRAY RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K770729 04/28/1977 PYELOSCOPE SYSTEM RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K770712 04/26/1977 TROCAR SLEEVE SYSTEM 4MM TO 3.4MM RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K770711 04/26/1977 TROCAR SLEEVE SYSTEM, 6.5MM TO 5.0MM RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K770501 04/05/1977 KNEE CUFF FOR EXPRESSING FLUID ROBERT R. MOORE
K770681 04/26/1977 VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR SCIMED LIFE SYSTEMS, INC.
K770306 04/05/1977 ANALYZER, 751 KINETIC/ENDPOINT SCLAVO, INC.
K770539 04/15/1977 FORCEPS, HAEM, DEEP OPERATION, 20&22 CM. SEA-PAC TRADING CORP.
K770538 04/15/1977 FORCEPS, HAEMOSTATIC, 14 16,&18 CM. LONG SEA-PAC TRADING CORP.
K770540 04/15/1977 FORCEPS, MOSQUITO STYLE, 12.5 CM. SEA-PAC TRADING CORP.
K770544 04/15/1977 SCISSORS, BANDAGE, 15,18,20CM., ANGULAR SEA-PAC TRADING CORP.
K770542 04/15/1977 SCISSORS, MAYO _TYLE, 14,16,18,20,22 CM. SEA-PAC TRADING CORP.
K770541 04/15/1977 SCISSORS, SURGICAL, 12.5,14,16 & 18 CM. SEA-PAC TRADING CORP.
K770543 04/15/1977 SCISSORS, SURGICAL, ANGULAR, 14 CM. SEA-PAC TRADING CORP.
K770511 04/29/1977 CANNULA, INTRAVENOUS, HEPARINIZED SHERWOOD MEDICAL INDUSTRIES
K770505 04/05/1977 SHAKE-N-WARM SIGNAL WEST
K770464 04/08/1977 TOOTHBRUSH, PLAK-A-DENT SMITH, RANSCHT, POLLOCK, MANOS & CONNOR
K770726 04/28/1977 RIA KIT, T4 CLASP SQUIBB & SONS, INC.
K770667 04/20/1977 CHROMASCAN TM STERNDENT CORP.
K770575 04/26/1977 ECHOENCEPHALOGRAPH, DIGITAL, 1000 STORZ INSTRUMENT CO.
K770585 04/05/1977 AEROSOL T ADAPTER, #752 SURGICOT, INC.
K770593 04/19/1977 CORRUGATED TUBING #770 & 771 SURGICOT, INC.
K770586 04/05/1977 UNIVERSAL MOUTHPIECE, #750 SURGICOT, INC.
K770587 04/05/1977 VENTILATOR ADAPTOR, #751 SURGICOT, INC.
K770560 04/05/1977 BARRIER O.B. PACK IV SURGIKOS, INC.
K770380 04/15/1977 CHEMISTRY CONTROL-LOW & HIGH TQC TM TECHNICON INSTRUMENTS CORP.
K770526 04/08/1977 DIGITAL SCANNER THE PERKIN-ELMER CORP.
K770721 04/28/1977 MONITORS, REMOTE, RMS III THE PERKIN-ELMER CORP.
K770621 04/06/1977 STOCKINETTE, SURGICAL THE TORRENT CORP.
K770500 04/05/1977 3 PORT LUER UNIMETRICS CORP.
K770530 04/05/1977 CLEON IMAGER UNION CARBIDE CORP.
K770515 04/05/1977 DISPENSER, TECHNETIUM, CLINTICHEM UNION CARBIDE CORP.
K770531 04/05/1977 UNICAM I UNION CARBIDE CORP.
K770529 04/05/1977 UNICET I UNION CARBIDE CORP.
K770644 04/14/1977 ULTRASOUND B-SCANNING SYSTEM UNIRAD CORP.
K770569 04/05/1977 CATHETER, EMBOLECTOMY, UMI UNIVERSAL MEDICAL INSTRUMENT CORP.
K770561 04/26/1977 CATHETER,PERCUTANEOUS INTRODUC. & SHEATH USCI, DIV. C.R. BARD, INC.
K770280 04/15/1977 CORD, ELECTROSURGICAL-STERILE & DISPOS. V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K770443 04/08/1977 SPECTROPHOTOMETER ANALYSIS SYS., AA-175 VARIAN ASSOC., INC.
K770444 04/08/1977 SPECTROPHOTOMETER ANALYSIS SYS., AA-375 VARIAN ASSOC., INC.
K770387 04/05/1977 UNICATCH W.G. WHITNEY CORP.
K770600 04/08/1977 OROPHARYNGEAL SUCTION AIRWAY W.H. WALL, D.D.S.
K770769 04/29/1977 OTOSCOPE/ILLUMINATOR, MODEL #21100 WELCH ALLYN, INC.
K770770 04/29/1977 WALL CHARGER, MODEL #79111 WELCH ALLYN, INC.
K770689 04/20/1977 HEARING AID MODEL A8H AND A8T WIDEX HEARING AID CO., INC.
K770688 04/20/1977 HEARING AID MODEL F8H ANL F8T WIDEX HEARING AID CO., INC.
K770611 04/08/1977 PARALLEL BARS WILL ROSS CO.
K770612 04/08/1977 SPLINT, BOHLER WILL ROSS CO.
K770609 04/08/1977 TABLE, MASSAGE & TREATMHNT, FIXED HEIGHT WILL ROSS CO.
K770509 04/05/1977 TABLE, MASSAGE AND TREATMENT WILL ROSS CO.
K770610 04/08/1977 TABLE, TREATMENT & TRACTION, HI-LO WILL ROSS CO.
K770607 04/08/1977 TRACTION HARNESS WILL ROSS CO.
K770608 04/08/1977 WALKING AID WILL ROSS CO.


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