FDA 510(k) Applications Received During June, 1977

FDA 510(k) Number Submission Date Device Name Applicant Contact
K771129 06/23/1977 AUTO-LOGIC II SYSTEM ABBOTT LABORATORIES
K771134 06/23/1977 ANESTHESIA BREATHING CIRCUIT AIR PRODUCTS & CHEMICALS, INC.
K771150 06/27/1977 COPPER KETTLE VAPORIZER PLUS AIR PRODUCTS & CHEMICALS, INC.
K771049 06/10/1977 ENDOSCOPIC TRAY AMERICAN HOSPITAL SUPPLY CORP.
K771050 06/10/1977 HYPERALIMENTATION TRAY AMERICAN HOSPITAL SUPPLY CORP.
K771024 06/08/1977 CHOLINESTERASE REAGENT SYSTEM AMERICAN MONITOR CORP.
K771045 06/10/1977 BLADES, SCALPEL AMERICAN SAFETY RAZOR CO.
K771008 06/03/1977 API 20C ANALYTICAL PRODUCTS, INC.
K771007 06/03/1977 ELECTROSURGICAL POWER GENERATORS ASPEN LABORATORIES, INC.
K771096 06/20/1977 TELHTHERAPY SIMULATOR AECL-CP, G-3200 ATOMIC ENERGY OF CANADA
K771021 06/06/1977 AUTO-CLIP AXIOM MEDICAL, INC.
K771022 06/06/1977 CATHETER, UMBILICAR ARTERY AXIOM MEDICAL, INC.
K771048 06/10/1977 CATHETERS, DRAINAGE AXIOM MEDICAL, INC.
K771058 06/13/1977 EPTONE BACK-UP BROTH, VACUTAINER BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771061 06/13/1977 ODUFLEX AEROSOL SET BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771270 06/20/1977 BLOOD ADMINISTRATION TYPE R BERMAN, PCP & CONSULTANTS, INC.
K771269 06/20/1977 BLOOD COLLECTION SET TYPE H BERMAN, PCP & CONSULTANTS, INC.
K771272 06/20/1977 DISP. SYRINGES: 2,5 & L0 MI. BERMAN, PCP & CONSULTANTS, INC.
K771268 06/20/1977 INFUSION SET TYPE J BERMAN, PCP & CONSULTANTS, INC.
K771267 06/20/1977 INFUSION SET TYPE S BERMAN, PCP & CONSULTANTS, INC.
K771271 06/20/1977 SCALP VEIN SET BERMAN, PCP & CONSULTANTS, INC.
K771023 06/08/1977 ANALOG QUANTIFIER MODEL AQ-100 BIO-FEEDBACK SYSTEMS, INC.
K771047 06/10/1977 QUANTA-MATE VITAMIN B-12/FOLATE RA BIO-RAD
K771135 06/23/1977 QUANTIMUNE NEONATAL & THYROXINE RIA BIO-RAD
K771139 06/27/1977 CRP-WELLCOTEST BURROUGHS WELLCOME CO.
K771149 06/27/1977 ENDOMETRIAL ASPIRATION BIOSPY KIT 182341 C.R. BARD, INC.
K771074 06/14/1977 NASAL OXYGEN CANNULA, #017207 C.R. BARD, INC.
K771075 06/14/1977 OXYGEN CONNECTING TUBE #017205 C.R. BARD, INC.
K771028 06/09/1977 ANALYZER, OXYGEN, MODEL OM-92 CAVITRON CORP.
K771025 06/08/1977 PHOTOTHERAPY/PROCEDURE LAMP CAVITRON CORP.
K771043 06/09/1977 SWAN GANZ CLINCAL INSTRUMENTS CORP.
K771117 06/21/1977 CENTRIA CORTISOL RIA CLINICAL DIAGNOSTICS, INC.
K771118 06/21/1977 CENTRIA SEPARATION COLUMNS TYPE A CLINICAL DIAGNOSTICS, INC.
K771015 06/06/1977 VYGON RED-O-PACK COASTAL BEND MEDICAL PRODUCTS, INC.
K771026 06/08/1977 HUANG VEIN HOLDER, #21-8011 CODMAN & SHURTLEFF, INC.
K771103 06/20/1977 URETHRAL TRAY W/CATHETER, 7750 CONCORD LABORATORIES, INC.
K771104 06/20/1977 URETHRAL TRAY W/OUT CAHTETER, 7650 CONCORD LABORATORIES, INC.
K771070 06/14/1977 DRY HEAT STERILIZER CPAC, INC.
K771071 06/14/1977 PORTO-VAC CPAC, INC.
K771138 06/24/1977 PIPETS BOROSILICATE GLASS DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K771137 06/24/1977 PIPETS UNIFORM DROP SIZE BOROSILICATE DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K771014 06/06/1977 TS-100 TEST SYSTEM DELTA MEDICAL INDUSTRIES
K771006 06/02/1977 MODIFIED PODIATRY PRODUCTS DENTRONIX INC.
K771005 06/02/1977 NEW PODIATRY PRODUCTS DENTRONIX INC.
K771179 06/30/1977 BIOBOND MASTER STAIN AND GLAZE KIT DENTSPLY INTL.
K771176 06/30/1977 GOTHIC ARCH TRACING DENTSPLY INTL.
K771039 06/09/1977 RESPIRATOR, PROTABLE, VOLUME CONTROLLED DEPT. OF THE NAVY
K771072 06/14/1977 INSERTEO, META.-PHAL.&THUMB CARPO-META DEPUY, INC.
K771009 06/03/1977 ELECTRO-SURGICAL DEVICES DESERET PHARMACEUTICAL CO.
K771124 06/22/1977 INSTRUMENT TRAY PAD DEVON INDUSTRIES, INC.
K771125 06/22/1977 POLYURETHANE PROD. FOR I.V. NEEDLES DEVON INDUSTRIES, INC.
K771123 06/22/1977 SURGICAL INSTRUMENT PROTECTOR DEVON INDUSTRIES, INC.
K771158 06/27/1977 ID BRACLETS, ADULT & INFANT DIVERS-A-MED
K771034 06/10/1977 HI-MID CURCUIT DRAEGER MEDICAL, INC.
K771097 06/20/1977 FORCEP, DISP., A CLAMP DRAVON MEDICAL, INC.
K771142 06/27/1977 T3 CLASP RIA KIT E. R. SQUIBB & SONS, INC.
K771003 06/02/1977 LIEBERMAN POLACK DOUBLE CORNEAL FORCEPS EDWARD WECK, INC.
K771046 06/10/1977 VENA CAVA UMBRELLA FILTER, MODEL 7321 EDWARDS LABORATORIES
K770999 06/02/1977 LITTON 300L ULTRASOUND SYSTEM ELECTRA-PHYSICS LABORATORIES, INC.
K771013 06/06/1977 MOSQUITO EMDE CORP.
K771067 06/13/1977 CHOLESTEROL KIT ENVIRONMENTAL CHEMICAL SPECIALTIES
K771068 06/13/1977 TRIGLYCERIDE KIT ENVIRONMENTAL CHEMICAL SPECIALTIES
K771120 06/22/1977 IMPREFLEX ALGINATE IMPRESSION MATERIAL ESPE DENTAL PRODUCTS
K771119 06/22/1977 PASTES, RESTORATIVE & TINTED, DEBTAL ESPE DENTAL PRODUCTS
K771057 06/13/1977 ANESTHESIA MACHINE FOREGGER
K771287 06/13/1977 FINGEO EXTENSION SPLINTS FRED SAMMONS, INC.
K771279 06/13/1977 HEAD FACILITATION VIBRATOR BK-5210 FRED SAMMONS, INC.
K771288 06/13/1977 JAMAR DYNAMOMETEO BK-7498 FRED SAMMONS, INC.
K771274 06/13/1977 QUADRIPLEGIC MEAT KNIFE FRED SAMMONS, INC.
K771180 06/30/1977 GAMMA GOUNTING SYS., AUTO, MODEL 1400 G.D. SEARLE AND CO.
K771083 06/16/1977 SEQUENTIAL PRESSURE CUFF GAYMAR INDUSTRIES, INC.
K771151 06/24/1977 ARTIUS SYSTEM GENERAL ELECTRIC CO.
K771051 06/09/1977 C-ARM X-RAY SYSTEM GENERAL ELECTRIC CO.
K771064 06/13/1977 ANA TEST GULL LABORATORIES, INC.
K771062 06/13/1977 EBV TEST GULL LABORATORIES, INC.
K771063 06/13/1977 HSV TEST GULL LABORATORIES, INC.
K771018 06/06/1977 TRANS 2000 HAMILTON INDUSTRIES, INC.
K771131 06/23/1977 CLINICARD UV AMYLASE CHEMISTRY HARLECO
K771094 06/16/1977 UNIPAK ALBUMIN HARLECO
K771087 06/16/1977 UNIPAK BUN HARLECO
K771093 06/16/1977 UNIPAK CHOLESTEROL HARLECO
K771091 06/16/1977 UNIPAK GLUCOSE HARLECO
K771090 06/16/1977 UNIPAK HEMOGLOBIN HARLECO
K771092 06/16/1977 UNIPAK TOTAL & DIRECT BILIRUBIN HARLECO
K771089 06/16/1977 UNIPAK TOTAL BILIRUBIN HARLECO
K771088 06/16/1977 UNIPAK URIC ACID HARLECO
K771000 06/03/1977 TRENDAR HI CHEM, INC.
K771105 06/20/1977 NEBULIZER, MOLEL 503, PART #17068 HOSPAL MEDICAL CORP.
K771110 06/20/1977 HERITAGE SPECIAL ALLOY HOWMEDICA CORP.
K771016 06/06/1977 INTERMEDULLARY BRUSH HOWMEDICA CORP.
K771185 06/29/1977 PERIODONTIC TOOTHBRUSH, #0126-0190-00 HOYT LABORATORIES
K771184 06/29/1977 TOOTHBRUSH, ORTHODONTIC, #0126-0189-00 HOYT LABORATORIES
K771183 06/29/1977 TOOTHBRUSH, PEDODONTIC, #0126-0188-00 HOYT LABORATORIES
K771107 06/20/1977 COUNTER 700 & HC-700 HEMO 0 REF. HYCEL, INC.
K771154 06/28/1977 CPK-INT TEST HYCEL, INC.
K771044 06/10/1977 TMA BICARBONATE DILUENT HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K771080 06/15/1977 STEAM STERILIZATION INDICATOR INFO-CHEM
K771037 06/10/1977 THERMOMETER, SINGLE USE, STRIP, TEMPADOT INFO-CHEM
K770994 06/01/1977 FURNACE AUTOSAMPLER, MODEL 155 INSTRUMENTATION LABORATORY CO.
K771060 06/13/1977 DIAG. CONDUCTA RATE BUN REAG. SET J.T. BAKER CHEMICAL CO.
K771059 06/13/1977 DIAG. OZYRATE GLUCOSE REAG. SET J.T. BAKER CHEMICAL CO.
K771153 06/27/1977 DYNA ZYME II GOT 340 J.T. BAKER CHEMICAL CO.
K771085 06/16/1977 DYNAZYME II ALKALINE PHOSPHATASE J.T. BAKER CHEMICAL CO.
K771152 06/27/1977 DYNAZYME II GPT 340 J.T. BAKER CHEMICAL CO.
K771084 06/16/1977 DYNAZYME II Y-GT J.T. BAKER CHEMICAL CO.
K771108 06/20/1977 NEEDLE, CHIBA UNIVERSITY JOHANNAH MEDICAL SERVICES, INC.
K771147 06/27/1977 AVL BLOOD GAS INSTRUMENT MODEL 939 JONES MEDICAL INSTRUMENT CO.
K771079 06/15/1977 CURITY IRRIGATION TRAY KENDALL RESEARCH CENTER
K771144 06/27/1977 RHODAMINE-CONJUGATED ANTISERUM KENT LABORATORIES, INC.
K771076 06/15/1977 ORTHODONTIC BRACKET ADHESIVE LEE PHARMACEUTICALS
K771077 06/15/1977 ULTRAVIOLET RAD-EMITTING LAMP LEE PHARMACEUTICALS
K770991 06/01/1977 SERUM GLUTAMIC PYRUVIC TRANSAMINASE MACOMB CHEMICAL CO.
K770993 06/01/1977 TRIGLYCERIDE REAGENT SET MACOMB CHEMICAL CO.
K771175 06/29/1977 RESUSCITATOR, MS30 MCKESSON CORP.
K771121 06/22/1977 EMPTY ADMIXTURE CONTAINERS MEDI, INC.
K771155 06/28/1977 ANTI-MITOCHONDRIAL MELOY LABORATORIES, INC.
K771066 06/13/1977 CATHETER, SAMPLING, CONDUIT MENTOR CORP.
K771033 06/09/1977 SMAC SYS., SUPPLEMENTAL PRODUCTS FOR MID TECH, INC.
K771004 06/02/1977 AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI MILES LABORATORIES, INC.
K771035 06/10/1977 CULTURE TEST FOR NEISSERIA GONORRHOEAE MILES LABORATORIES, INC.
K771065 06/13/1977 DYLADE, MODEL DS MILTON ROY CO. ANALYTICAL
K771002 06/02/1977 ICE BAND NORCLIFF THAYER, INC.
K771095 06/20/1977 "J" HOOK HEADGEAR NORTHWEST ORTHODONTICS, INC.
K770995 06/01/1977 AEROSOL MASK OHIO MEDICAL PRODUCTS
K770996 06/01/1977 OXYGEN CANNULA OHIO MEDICAL PRODUCTS
K771082 06/15/1977 DELTASCAN 2000 SERIES OHIO NUCLEAR, INC.
K771038 06/10/1977 THERMOMETER, SINGLE USE, STRIP, TEMPADOT ORGANON, INC.
K771109 06/20/1977 ORTHOPEDIC SOFT GOODS ORTHOPEDIC SYSTEMS, INC.
K771020 06/06/1977 SPINAL SURGERY FRAME ORTHOPEDIC SYSTEMS, INC.
K771036 06/10/1977 SHAVE PREP TRAY PARKE-DAVIS CO.
K771011 06/06/1977 ARTICULATING PAPER PARKER LABORATORIES, INC.
K771130 06/23/1977 DESENSITRON PARKER LABORATORIES, INC.
K771012 06/06/1977 ASSURE DEODORANT TAMPONS PERSONAL PRODUCTS CO.
K771078 06/15/1977 PHADEBAS T3 U TEST PHARMACIA, INC.
K771136 06/23/1977 SURGICAL HEAD DRAPE, DISP. PROCTER & GAMBLE MFG. CO.
K771029 06/09/1977 MULTISONIC (DELUXE) CODE TDM QUALITONE
K771069 06/13/1977 MULTISONIC (SUPER) CODE TSM QUALITONE
K771019 06/06/1977 LUNG-MECHANICS MONITOR RESEARCH DEVELOPMENT CORP.
K771157 06/28/1977 RM VI-HV RICH-MAR CORP.
K771114 06/21/1977 NEUTROCIM SEPTODONT, INC.
K771054 06/13/1977 BLOOD COLLECTION TUBE, BLUE SHERWOOD MEDICAL INDUSTRIES
K771053 06/13/1977 BLOOD COLLECTION TUBE, GRAY SHERWOOD MEDICAL INDUSTRIES
K771056 06/13/1977 BLOOD COLLECTION TUBE, GREEN SHERWOOD MEDICAL INDUSTRIES
K771052 06/13/1977 BLOOD COLLECTION TUBE, LAVENDER SHERWOOD MEDICAL INDUSTRIES
K771055 06/13/1977 BLOOD COLLECTION TUBE, RED SHERWOOD MEDICAL INDUSTRIES
K771116 06/16/1977 CATHETER, PO2, INTRAVASUCLAR, CITADEL SHERWOOD MEDICAL INDUSTRIES
K771017 06/06/1977 CITADEL CPAP ACCESSORY KIT SHERWOOD MEDICAL INDUSTRIES
K771042 06/09/1977 INTRODUCER, CAT. #INT-05FR. SORENSEN RESEARCH
K771041 06/09/1977 INTRODUCER, CAT. #INT-06FR. SORENSEN RESEARCH
K771040 06/10/1977 INTRODUCER, CAT. #INT-07FR. SORENSEN RESEARCH
K771030 06/09/1977 FLEXION MITTENS STAT MEDICAL CORP.
K771031 06/09/1977 STROKE SLING STAT MEDICAL CORP.
K771128 06/23/1977 NEKO CERAMIC CONVENIENCE CROWNS STERNDENT CORP.
K771032 06/09/1977 POUCHES, PEEL OPEN, BREATHABLE SURGICOT, INC.
K771098 06/20/1977 BLOOD GROUPING SYS., BG-9 TECHNICON INSTRUMENTS CORP.
K770998 06/02/1977 CHOLESTEROL REAGENT SET THE DOW CHEMICAL CO.
K771101 06/20/1977 HEMOGLOBIN ANALYZER & PERFORM. CHECK SET THE DOW CHEMICAL CO.
K771102 06/20/1977 UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS THE DOW CHEMICAL CO.
K771156 06/28/1977 MONITOR, LIQ. CHROMATOGRAPHY LC-15 UV THE PERKIN-ELMER CORP.
K771298 06/09/1977 6" L.L. SYSTEM TOSHIBA MEDICAL SYSTEMS
K771290 06/09/1977 CONTACT COMPOUNT SONOLAY. SAC-10A TOSHIBA MEDICAL SYSTEMS
K771292 06/09/1977 HIGH-SPEED SECTOR SCANNING SSL-52H TOSHIBA MEDICAL SYSTEMS
K771291 06/09/1977 IMAGE SCANNING TYPE SONOLAY. SAL-10A TOSHIBA MEDICAL SYSTEMS
K771296 06/09/1977 TUBE CONVEYOR MODEL DS-PB-4 TOSHIBA MEDICAL SYSTEMS
K771297 06/09/1977 TUBESTAND MODEL DS-TA-4 TOSHIBA MEDICAL SYSTEMS
K771293 06/09/1977 X-RAY DIAG. TABLE DT-KCS TOSHIBA MEDICAL SYSTEMS
K771295 06/09/1977 X-RAY GENERATOR MODEL KX0-825 TOSHIBA MEDICAL SYSTEMS
K771294 06/09/1977 X-RAY GENERATOR MODEL KXO-15 TOSHIBA MEDICAL SYSTEMS
K771146 06/22/1977 STEOILITY TESTING VESSEL TOWER PRODUCTS, INC.
K771027 06/08/1977 ELECTROCARDIOGRAPHIC PATIENT CABLES TRONOMED, INC.
K771112 06/21/1977 AUTO SUTURE R CLIP UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K771113 06/21/1977 AUTO SUTURE R CLIP INSTRUMENT UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K771178 06/30/1977 DISP. LOADING UNIT, AUTO, SUTURE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K771177 06/30/1977 SURGICAL STAPLING INSTRU., AUTO, SUTURE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K771073 06/14/1977 GAS CHROMA. ANALYSIS SYS., SERIES 37111 VARIAN ASSOC., INC.
K771122 06/22/1977 VERI/CTGS MODEL 850 VERITE SCIENTIFIC, INC.
K771181 06/30/1977 VAGINAL ILLUMINATOR, MODEL 78570 WELCH ALLYN, INC.
K771132 06/23/1977 KENWOOD BIOLOGICAL STEOILIZ. INDICATOR WILL ROSS CO.
K771081 06/15/1977 LITECAST CERAMIC WILLIAMS GOLD REFINING CO., INC.
K771145 06/27/1977 WILL-CERAM W-2 WILLIAMS GOLD REFINING CO., INC.
K771143 06/27/1977 INORGANIC PHOSPHORUS STANDARDS WORTHINGTON BIOCHEMICAL CORP.
K771001 06/03/1977 STATZYME GLUCOSE WORTHINGTON BIOCHEMICAL CORP.
K770997 06/01/1977 PRO-CARE YOUNG DENTAL MANUFACTURING CO 1, LLC.
K771106 06/20/1977 FORCEPS, OB, NON-COMPRESSIVE ZEPPELIN MEDIZINLECHNIK GMBH


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