FDA 510(k) Applications Received During April, 1978

FDA 510(k) Number Submission Date Device Name Applicant Contact
K780637 04/17/1978 HEMATOLOGY SLIDE STAINER A. J. P. SCIENTIFIC, INC.
K780616 04/13/1978 HYDRON BURN DISPOSABLE DISPENSER SET ABBOTT LABORATORIES
K780565 04/06/1978 SUTURELESS SKIN CLOSURE ABBOTT LABORATORIES
K780601 04/10/1978 AIRWAYS ABCO DEALERS, INC.
K780606 04/10/1978 BANDAGE ABCO DEALERS, INC.
K780603 04/10/1978 COLD PACK ABCO DEALERS, INC.
K780597 04/10/1978 ECG PAPER, 3 CHANNEL ABCO DEALERS, INC.
K780613 04/10/1978 ENEMA, PHOSPHATE ABCO DEALERS, INC.
K780608 04/10/1978 ICE BAG, VINYL ABCO DEALERS, INC.
K780610 04/10/1978 INSTRUMENT LUBRICANT ABCO DEALERS, INC.
K780600 04/10/1978 IRRIGATION TRAY ABCO DEALERS, INC.
K780605 04/10/1978 ISOLATION GOWN ABCO DEALERS, INC.
K780609 04/10/1978 MASK, ISOLATION ABCO DEALERS, INC.
K780607 04/10/1978 MASK, SURGEONS ABCO DEALERS, INC.
K780595 04/10/1978 MINI-IRRIGATION TRAY ABCO DEALERS, INC.
K780593 04/10/1978 PROBE COVER ABCO DEALERS, INC.
K780604 04/10/1978 SHAVE PREP ABCO DEALERS, INC.
K780590 04/10/1978 SHOE COVERS ABCO DEALERS, INC.
K780612 04/10/1978 STOCKINETTE, STERILE ABCO DEALERS, INC.
K780596 04/10/1978 STOPCOCK ABCO DEALERS, INC.
K780602 04/10/1978 SYRINGE (IRRIGATION) ABCO DEALERS, INC.
K780599 04/10/1978 SYRINGE, EAR & ULCER ABCO DEALERS, INC.
K780591 04/10/1978 THERMOMETER KIT ABCO DEALERS, INC.
K780592 04/10/1978 TRANSFER PIPET ABCO DEALERS, INC.
K780598 04/10/1978 TREND II ANEROID ABCO DEALERS, INC.
K780594 04/10/1978 VELKET TOURNIQUET ABCO DEALERS, INC.
K780547 04/05/1978 STERILE ORTHOPEDIC STOCKINETTE ALBA-WALDENSIAN, INC.
K780570 04/10/1978 TUBULAR DRESSING RETAINER ALBA-WALDENSIAN, INC.
K780625 04/14/1978 UNISTAT OXIMETER AMERICAN OPTICAL CORP.
K780673 04/24/1978 CENTRAL CATHETER KIT ARGON MEDICAL CORP.
K780532 04/04/1978 PERCUTANEOUS SHEATH INTRODUCER KIT ARROW INTL., INC.
K780558 04/05/1978 BOTTLE BREATHING DEVICE B & F MEDICAL PRODUCTS, INC.
K780617 04/13/1978 EQUALIZER BALLERT ORTHOPEDIC CORP.
K780665 04/21/1978 RECAP BCA BIOLOGICAL CORP. OF AMERICA
K780530 04/04/1978 AUTOMATED PHYSIOLOGIC PROFILER BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780557 04/05/1978 FOLATE REAGENT KIT, ARIA-II SYSTEM BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780556 04/05/1978 SPECT RIM (LISS) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780573 04/10/1978 TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780554 04/05/1978 CLIN. CHEM. CONTROL SERUM-QUANTITATE BECKMAN INSTRUMENTS, INC.
K780552 04/05/1978 COMP. CLIN. CHEM. CONTROL SERUM-DECISION BECKMAN INSTRUMENTS, INC.
K780553 04/05/1978 COMP. CLIN. CHEM. REF. SERUM-BENCHMARK BECKMAN INSTRUMENTS, INC.
K780714 04/28/1978 PLATELET CONTROL BHP DIAGNOSTIX, INC.
K780583 04/12/1978 FOME-CUF PVC BIVONA MEDICAL TECHNOLOGIES
K780635 04/17/1978 REAGENT SET HDL CHOLESTEROL BOEHRINGER MANNHEIM CORP.
K780634 04/17/1978 SINGLE VIAL 10 SGOT-TRIS BOEHRINGER MANNHEIM CORP.
K780636 04/17/1978 SINGLE VIAL 10 SGPT-TRIS BOEHRINGER MANNHEIM CORP.
K780563 04/07/1978 SINGLE VIAL LACTATE BOEHRINGER MANNHEIM CORP.
K780702 04/25/1978 CSS-60 DIGITAL HEART RATE METER BURDICK CORP.
K780571 04/10/1978 BLOOD PRESSURE MODULE C-V MONITORS CORP.
K780572 04/10/1978 DCG PREAMPLIFIER MODULE C-V MONITORS CORP.
K780630 04/17/1978 CONTROLLER, SERVO, INSPIRON C.R. BARD, INC.
K780694 04/24/1978 HEARING AID BATTERY CHARGER CAHILL ENTERPRISES, INC.
K780669 04/21/1978 HEATING AIDS-MODEL C78A & C78B CIRCLE HEARING INSTRUMENTS, INC.
K780709 04/26/1978 IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST CLINICAL ASSAYS, INC.
K780707 04/25/1978 T4-RIA KIT CLINICAL BIORESEARCH
K780653 04/19/1978 EXTRACORPEAL CARDIOTOMY BLOOD FILTER COBE LABORATORIES, INC.
K780627 04/14/1978 SURG-O-PAK, GOWNS, SHEETS, AND TOWELS CONVERTORS
K780569 04/11/1978 L-12, L-21, AND L-22 ELECTRODES CORATOMIC, INC.
K780649 04/19/1978 FLAME PHOTOMETER, MODEL 435 CORNING MEDICAL & SCIENTIFIC
K780650 04/19/1978 FLAME PHOTOMETER, MODEL 455 CORNING MEDICAL & SCIENTIFIC
K780624 04/14/1978 CULDOCENTESIS TRAY CUTTER LABORATORIES, INC.
K780546 04/05/1978 BEHIND-THE-EAR MASKING AMPLIFIER,735S DANAVOX, INC.
K780663 04/20/1978 CONTACT LENS REMOVER AND INSERTER DMV CONTACT LENS CO.
K780664 04/20/1978 SOFT LENS REMOVER/INSERTER/MANIPULATOR DMV CONTACT LENS CO.
K780567 04/06/1978 AORTIC PUMP ETHICON, INC.
K780681 04/24/1978 ARTERIOVENOUS BLOOD TUBING SETS EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K780682 04/24/1978 SINGLE PATIENT SYSTEMS EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K780578 04/10/1978 SONOGRAF EDP REAL-TIME ADAPTER FOLEY, LARDNER, HOLLABAUGH & JACOBS
K780677 04/24/1978 4600 RECORDER G & W APPLIED SCIENCE LABORATORIES
K780566 04/06/1978 HEALTH SEAT SYSTEM G & W APPLIED SCIENCE LABORATORIES
K780700 04/26/1978 LUNDIA PLATE DISPOSABLE DIALYZER GAMBRO, INC.
K780577 04/10/1978 PLATELETS/CU MM GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K780533 04/04/1978 PRE-REDUCED MEDIA GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K780704 04/25/1978 COLUMBIA AGAR WITH 5% RABBIT BLOOD GRANITE DIAGNOSTICS, INC.
K780708 04/25/1978 AUTOMATIC RETRACTOR HOLDER GREAT EASTERN LUMBER CO., INC.
K780568 04/10/1978 DURAN FLEXIBLE RING HANCOCK LABORATORIES, INC.
K780705 04/25/1978 INFUSION PUMP-MODEL 2616 HARVARD APPARATUS, INC.
K780706 04/25/1978 LUMBAR NERVE ROOT SHIELD HEYER SCHULTE CORP.
K780651 04/19/1978 ULTRASONIC DIAGNOSTIC TRANSDUCER HOFFREL INSTRUMENTS, INC.
K780640 04/17/1978 DRY SILVER PROCESSOR MODEL 1226 HONEYWELL, INC.
K780527 04/03/1978 CORTRAL I HOSPAL MEDICAL CORP.
K780582 04/12/1978 DETECTOR, BUBBLE & FOAM HOSPAL MEDICAL CORP.
K780626 04/14/1978 VENTURI OXYGEN MASK HOSPITAK, INC.
K780711 04/27/1978 MICRO-RING HOWMEDICA CORP.
K780535 04/03/1978 HUMIDIFIER FILTER HUDSON OXYGEN THERAPY SALES CO.
K780744 04/13/1978 BRINKER TISSUE RETRACTORS HYGIENIC DENTAL MFG., CO., THE
K780743 04/13/1978 CLAMP FORCEPS HYGIENIC DENTAL MFG., CO., THE
K780746 04/13/1978 HYGIENIC RUBBER DAM FRAME HYGIENIC DENTAL MFG., CO., THE
K780745 04/13/1978 RUBBER DAM HYGIENIC DENTAL MFG., CO., THE
K780712 04/26/1978 KERR DISCOVERY DISPOSABLE FLUORIDE TRAY KERR CORPORATION (DANBURY)
K780559 04/05/1978 DISPOSABLE INFUSION SET KS MEDICAL SUPPLY CO.
K780560 04/05/1978 DENTAL AMALGAMATOR L.D. CAULK CO.
K780701 04/26/1978 DENTAL OFFICE ENVIRONMENT CONTROL UNIT LAMINAIRE CORP.
K780575 04/10/1978 LASCHAL SCISSOR LASCHAL INSTRUMENT CORP.
K780574 04/10/1978 SUTURE CUTTER LASCHAL INSTRUMENT CORP.
K780585 04/11/1978 SURGICAL LASER LASER INDUSTRIES LTD.
K780538 04/03/1978 AUDIO MONITOR-MODEL 8309 LIFE-TECH INSTRUMENTS, INC.
K780537 04/03/1978 EAR ELECTRODE-ADULT & PEDIATRIC LIFE-TECH INSTRUMENTS, INC.
K780540 04/03/1978 ELECTRIC RESPONSE AUDIOMETER LIFE-TECH INSTRUMENTS, INC.
K780541 04/03/1978 PRESSURE MODULES MODELS 1855 & 1856 LIFE-TECH INSTRUMENTS, INC.
K780539 04/03/1978 STIMULATOR MODEL 8021 LIFE-TECH INSTRUMENTS, INC.
K780659 04/20/1978 HDL CHOLESTEROL MACOMB CHEMICAL CO.
K780534 04/03/1978 UREA NITROGEN (ENZYMATIC) MACOMB CHEMICAL CO.
K780715 04/27/1978 ANEROID TYPE BLOOD PRESSURE KIT MARS METAL CO., LTD.
K780632 04/17/1978 MAXICEPTOR MED GENERAL
K780698 04/26/1978 STIMULATORS, NERVE, ELECTRICAL MED GENERAL
K780615 04/13/1978 BLOOD CULTURE MEDIA MEDA STAT DIAGNOSTICS, INC.
K780548 04/05/1978 DISPOSA-LOOPS MEDI-SPEC
K780646 04/17/1978 AIR-PWOERED COLDRILL MEDISHIELD, INC.
K780645 04/17/1978 HMD-2000 BATTERY-POWERED MINI-DRILL, THE MEDISHIELD, INC.
K780675 04/24/1978 STERILE 100% SILICONE FOLEY CATHETER MEDLINE INDUSTRIES, INC.
K780676 04/24/1978 STERILE CLOSED SYSTEM MEDLINE INDUSTRIES, INC.
K780622 04/14/1978 BIPOLAR ENDOCARDIAL PACING LEAD, M. 6902 MEDTRONIC VASCULAR
K780623 04/14/1978 ENDOCARDIAL ATRIAL PACING LEAD, M. 6994 MEDTRONIC VASCULAR
K780621 04/14/1978 LEAD, PACING, ATRIAL, ENDOCARDIAL, TINED MEDTRONIC VASCULAR
K780579 04/10/1978 SUBCUPASS TUNNELING TOOL MEDTRONIC VASCULAR
K780561 04/07/1978 VENTRICULAR INHIBITED PULSE GENERATOR MEDTRONIC VASCULAR
K780551 04/05/1978 I.V. ADMINISTRATION SET WITH MINI-SPIKE NATIONAL PATENT DEVELOPMENT CORP.
K780549 04/05/1978 NON-STICK PADS NATIONAL PATENT DEVELOPMENT CORP.
K780550 04/05/1978 STERILE AIR SYRINGE NATIONAL PATENT DEVELOPMENT CORP.
K780631 04/17/1978 NDM INFANT ECG PACKPAD NEW DIMENSIONS IN MEDICINE, INC.
K780660 04/20/1978 NITE TRAIN'R NITE TRAIN-R ENTERPRISES, INC.
K780697 04/24/1978 GOAT ANTI-INFLUENZA ANTISERA ATEXAS NORTHEAST BIOMEDICAL LABS., INC.
K780696 04/24/1978 GOAT ANTIINFLUENZA ANTISERA AUSSR NORTHEAST BIOMEDICAL LABS., INC.
K780662 04/18/1978 SUPPLEMENTAL TYGON PAC-MONITORING LINES NORTON PERFORMANCE PLASTICS CORP.
K780644 04/17/1978 RADIOASSAY FOR TOTAL SERUM THYROXINE NUCLEAR DIAGNOSTICS, INC.
K780679 04/24/1978 B-HCG-RIA NUCLEAR MEDICAL SYSTEMS, INC.
K780703 04/25/1978 CUFF PACER OMP LABORATORIES, INC.
K780699 04/26/1978 EARETTE HEARING AID OPTICON CORP.
K780684 04/24/1978 PATIENT LIFT ORTHOPEDIC EQUIPMENT CO., INC.
K780654 04/19/1978 HEARING AID, EARETTE OTICON CORP.
K780564 04/06/1978 FECATEST OTTO C. WATZKA
K780542 04/03/1978 ALFATEST PANMED, INC.
K780576 04/10/1978 125-I LABELED HUMAN LUTEINIZING HORMONE PCL-RIA, INC.
K780587 04/11/1978 GYNESURG POLAMEDCO, INC.
K780528 04/03/1978 PREMIER CARVERS, STYLE #21C & 21D PREMIER DENTAL PRODUCTS CO.
K780683 04/24/1978 TISSUE PULSATOR PULSATOR CORP.
K780643 04/17/1978 SHADOW-CATHS QUINTON, INC.
K780667 04/21/1978 HEARING AID-MODEL 2010 RADIOEAR CORP.
K780671 04/24/1978 125 I-T3 UPTAKE REAGENT RADIOIMMUNOASSAY, INC.
K780672 04/24/1978 125 I-T4 RIA REAGENT RADIOIMMUNOASSAY, INC.
K780562 04/07/1978 AQUAPAK PREFILLED HUMIDIFIER RESPIRATORY CARE, INC.
K780580 04/10/1978 TEMPERATURE INDICATOR RESPIRATORY CARE, INC.
K780586 04/12/1978 MICROCLIP, WILLIAMS RICHARD'S MEDICAL EQUIP., INC.
K780678 04/24/1978 IMPRESSION TRAY ROCKY MOUNTAIN ORTHODONTICS, INC.
K780713 04/27/1978 CULTURE SWAB ROYAL SCIENTIFIC, INC.
K780529 04/03/1978 MYOCATH KIT SORENSEN RESEARCH
K780545 04/03/1978 SR-PLUS DIRECT CHOLESTEROL TEST STANBIO LABORATORY
K780658 04/20/1978 STERILE BLOOD ADMINISTRATION SET SURU CHEMICALS & PHARMACEUTICALS, LTD.
K780657 04/20/1978 STERILE BLOOD COLLECTION SET SURU CHEMICALS & PHARMACEUTICALS, LTD.
K780656 04/20/1978 STERILE INFUSION SET TYPE J SURU CHEMICALS & PHARMACEUTICALS, LTD.
K780655 04/20/1978 STERILE INFUSION SET TYPE S SURU CHEMICALS & PHARMACEUTICALS, LTD.
K780639 04/17/1978 EMIT CENTRIFICHEM THYROXINE ASSAY SYVA CO.
K780648 04/17/1978 MODIFIED UNTREATED TAMPAX TAMPONS TAMPAX, INC.
K780544 04/03/1978 DISC-PAK ROTATOR TECHHNILAB INSTRUMENTS, INC.
K780543 04/03/1978 THERMAJUST CIRCU-TEMP TECHHNILAB INSTRUMENTS, INC.
K780716 04/27/1978 TECHNICON BGII ANALYZER TECHNICON INSTRUMENTS CORP.
K780641 04/17/1978 DENTAL ROTARY CARBIDE BURS 76EJL TELEDYNE DENSCO
K780638 04/18/1978 ACCESSORY HDL CHOLESTEROL REAGENT SET THE DOW CHEMICAL CO.
K780652 04/17/1978 HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 THE LONDON CO.
K780680 04/24/1978 UNIT, SPECTRA, CORRECTED, DIFFERENTIAL THE PERKIN-ELMER CORP.
K780710 04/27/1978 AIR MASSAGE SYSTEM THERACOM C/O ARENT, FOX, KINTNER, PLOTKI
K780619 04/13/1978 PREFORMED TOOTH POSITIONER TP LABORATORIES, INC.
K780668 04/21/1978 SOLUTIONS FOR RESPIRATORY THERAPY TRAVENOL LABORATORIES, S.A.
K780695 04/24/1978 AUTO SUTURE DISPOSABLE STAPLING INSTRU. UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K780717 04/27/1978 EXTERNAL TEST PULSE GENERATOR VITATRON MEDICAL BV
K780584 04/11/1978 PULMONARY FUNCTION TESTER WARREN E. COLLINS, INC.
K780628 04/17/1978 HALOGEN EXAM. LITE #48400 WELCH ALLYN, INC.
K780642 04/17/1978 LITECAST SOLDER WILLIAMS GOLD REFINING CO., INC.


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