FDA 510(k) Decisions During March, 1977  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K770429 03/16/1977 CANNULAE, AORTIC, ARCH, HIGH FLOW 3M HEALTH CARE, SARNS
K770430 03/16/1977 CATHETER, CURVED LEFT HEART VENT 3M HEALTH CARE, SARNS
K770431 03/16/1977 CATHETER, TWO STAGE VENOUS RETURN 3M HEALTH CARE, SARNS
K770182 03/15/1977 0.22/UM FILTERSET W/Y-INJECTION SITE ABBOTT LABORATORIES
K770403 03/16/1977 CATHETER-THRU-NEEDLE DEVICE ABBOTT LABORATORIES
K770404 03/16/1977 OBTURATOR ABBOTT LABORATORIES
K770418 03/23/1977 RETRACTOR, SKIN HOOK ACME UNITED CORP.
K770217 03/30/1977 LANCE LTD. STERI. STITCH CUTTER BLADE AEROCEUTICALS
K770181 03/30/1977 I.V. CATHETER PLACEMENT UNIT AMERICAN VIGGO
K770174 03/30/1977 LUER-LOCK EXTENSION SET AMERICAN VIGGO
K770397 03/10/1977 MONITOR, RADIOISOTOPE, MODEL 9273A AMERSHAM CORP.
K770416 03/10/1977 LEAD, HEART, BUTTERFLY CLAMP ARCO MEDICAL PRODUCTS CO.
K770290 03/15/1977 MONITORING KIT, CENTRAL VENOUS PRESSURE ARGON MEDICAL CORP.
K770461 03/16/1977 ANESTHESIA KIT, EPIDURAL BLOCK, CONTINU. ARROW INTL., INC.
K770356 03/01/1977 ANESTHESIA KIT, EPIDURAL, SINGLE SHOT ARROW INTL., INC.
K770462 03/14/1977 PUNCTURE KIT, INTERNAL JUGULAR ARROW INTL., INC.
K770068 03/01/1977 CANNULA, HUNTER-SESSIONS, SELF-RETAIN. BARLOW MFG., CORP.
K770395 03/21/1977 THROMBO-CETIN (RISTOCETIN) BAY AREA HEMA. ONCO. CLINIC. & RES. L
K770394 03/30/1977 THROMBO-SCREEN AT-111 KIT BAY AREA HEMA. ONCO. CLINIC. & RES. L
K770441 03/10/1977 GAR, COLUMBIA, W/5% HORSE BLOOD BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760942 03/07/1977 GENTASAK BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770386 03/21/1977 LATELET, CONTROL, NORMAL & ABNORMAL BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770015 03/16/1977 NOSECLIP FOR RESP. CARE & PULMON. FUNC. BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770185 03/14/1977 RH CONTROL DILUENT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K761289 03/28/1977 ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770426 03/15/1977 OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE BEL-MED, INC.
K770292 03/09/1977 MONITOR, FETAL HEART, MODEL 1980 BERKELEY BIO-ENGINEERING
K770271 03/16/1977 CHEMSTRIP G BOEHRINGER MANNHEIM CORP.
K770273 03/01/1977 TEST, AMMONIA, BMC REAGENTSET BOEHRINGER MANNHEIM CORP.
K770272 03/01/1977 URIC ACID TEST, BMC AUTOFLO BOEHRINGER MANNHEIM CORP.
K770295 03/09/1977 ABDOMINAL ECG PROCESSOR FOR FETAL MONI. BRATTLE INSTRUMENT CORP.
K770297 03/09/1977 FETAL MONITOR, PART #100-11009 BRATTLE INSTRUMENT CORP.
K770296 03/09/1977 FETAL MONITOR, PART #101-11009 BRATTLE INSTRUMENT CORP.
K770269 03/16/1977 CAMMADISK DIGOXIN BURROUGHS WELLCOME CO.
K760997 03/23/1977 UNDER BOTTOCKS DRAPE C.R. BARD, INC.
K770367 03/01/1977 ROOT CANAL FILES & REAMERS CEMCO TOOL CO., INC.
K770125 03/14/1977 DISPOS-A-CARE THERMOMETER SHEATH CHESEBROUGH-POND'S U.S.A. CO.
K770231 03/30/1977 MID-STREAM COLLECTION SET CHESIRE LABORATORIES
K770368 03/01/1977 ORAL IRRIGATOR CLAIROL, INC.
K761272 03/16/1977 CENTRIA T4 RIA CLINICAL DIAGNOSTICS, INC.
K770002 03/07/1977 CONSOLE, MOBILE FOR 3 PUMPS W/MASTS COBE LABORATORIES, INC.
K770383 03/07/1977 STOPCOCK, ONE WAY COBE LABORATORIES, INC.
K770389 03/14/1977 LENS SET, MENTOR TRIAL CODMAN & SHURTLEFF, INC.
K770163 03/30/1977 SUTURE CUTTER CONCEPT, INC.
K770557 03/24/1977 DRAINAGE BAG, 4000 ML. CONCORD LABORATORIES, INC.
K770497 03/21/1977 DRAINAGE UNIT, COMBINATION CONCORD LABORATORIES, INC.
K770496 03/21/1977 UNIVERSAL TRAY CONCORD LABORATORIES, INC.
K770346 03/07/1977 ORTHOPEDIC STOCKINETTE CONVERTORS
K770522 03/30/1977 CATHETER, GRUNTZIG, BALLON COOK, INC.
K770559 03/28/1977 C-L0L CARDIAC PACEMAKER CORATOMIC, INC.
K770478 03/30/1977 ADAPTER, CORDIS CORDIS CORP.
K770214 03/28/1977 TEMP. PERVENOUS LEAD W/REMOTE ANODE CORDIS CORP.
K770469 03/16/1977 CUTTER TUNGSTEN CARBIDE BURS CUTTER LABORATORIES, INC.
K770375 03/01/1977 FILTER, AIR, CUTTER MAINLINE CUTTER LABORATORIES, INC.
K770376 03/01/1977 FILTER, NEBULIZER, CUTTER CUTTER LABORATORIES, INC.
K770392 03/07/1977 MUFFLER, AIR PUMP CUTTER LABORATORIES, INC.
K770556 03/24/1977 PRO-KUP DENTAL CONTROL PRODUCTS
K770304 03/09/1977 CUTTER, P605 GENERAL PURPOSE DENTRONIX INC.
K770302 03/09/1977 CUTTER, P606 BONE DENTRONIX INC.
K770305 03/09/1977 CUTTER, P607 BONE DENTRONIX INC.
K770303 03/09/1977 NIPPER, NAIL, P610 ENGLISH DENTRONIX INC.
K770301 03/07/1977 NIPPER, PSO4 TISSUE DENTRONIX INC.
K770421 03/14/1977 COMPONENTS, ANKLE, TRIAL, CON-AXIAL DEPUY, INC.
K770420 03/14/1977 FORCEPS, ANKLE INSERTING, CON-AXIAL DEPUY, INC.
K770492 03/21/1977 CRACK DETECTOR, DEN-MAT DEY-MAT, INC.
K761157 03/01/1977 AMINOGLYCOSIDE (125I) RIA KIT DIAGNOSTIC PRODUCTS CORP.
K770369 03/01/1977 VACON TM DIEMOLDING CORP.
K770521 03/29/1977 ELECTROCARDIOGRAPHIC ELECTRODES, DISP. DOBRE, INC.
K770554 03/30/1977 NARKOMED ANESTHESIA MACHINE DRAEGER MEDICAL, INC.
K760462 03/01/1977 ELECTRICAL SHOCK DEVICE EDWARD V. KAUFHOLZ, SR.
K770503 03/30/1977 LOUISVILLE CLAMP PRODUCT #65-172 EDWARD WECK, INC.
K770211 03/07/1977 MICROPULSE MODEL 20S EDWARDS PACEMAKER SYSTEMS
K770212 03/09/1977 PROLITH MODEL 21S CARDIAC PULSE GEN. EDWARDS PACEMAKER SYSTEMS
K770427 03/16/1977 CATHETER INTRODUCER KIT ELECTRO-CATHETER CORP.
K770366 03/01/1977 ISOLATED ELECTROCARDIOGRAPH MODEL 1207 ELECTRONICS FOR MEDICINE, INC.
K770171 03/30/1977 ERIKA I.V. ADMINISTRATION SET ERIKA, INC.
K770382 03/08/1977 NEEDLE, FISTULA, ERIKA ERIKA, INC.
K770516 03/30/1977 MEMBRANE SOURCE-EX SERIES DIALYZER CART. EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K770216 03/01/1977 VIRAL ANTISERA, FLUORESCEIN LABELED FLOW LABORATORIES, INC.
K770276 03/09/1977 ELECTROTHERAPY APPARATUS E.T. 720 FORT & ASSOC.
K770082 03/16/1977 SALONMAY BUSTLINE INCREASER GAMMA ENTERPRISES, INC.
K770440 03/15/1977 IMPLANT, DENTAL, PYROLITE CARBON ENDO. GENERAL ATOMIC CO.
K761250 03/01/1977 SIMPLATE GENERAL DIAGNOSTICS
K770229 03/01/1977 AUTO-ENZYMATIC GLUCOSE HARLECO
K770408 03/15/1977 KARAYA GUM POWDER, OSTOMY HOWMEDICA CORP.
K770471 03/24/1977 KERBOULL-CHARNLEY CUP SPECIAL MODEL HOWMEDICA CORP.
K770473 03/17/1977 LAGRANGE LETOURNEL TOTAL HIP FEMORAL HOWMEDICA CORP.
K761340 03/07/1977 OSTOMY KARAYA GUM POWDER HOWMEDICA CORP.
K770472 03/17/1977 PROSTHESIS, VIDAL TOTAL HIP HOWMEDICA CORP.
K770487 03/21/1977 LIGHTWEIGHT PLASTIC CANNULA HUDSON OXYGEN THERAPY SALES CO.
K770342 03/01/1977 RECORDER, CHART, MODEL 5536 HUDSON OXYGEN THERAPY SALES CO.
K770437 03/23/1977 TABLE, EXAMINATION I E INDUSTRIES
K770209 03/07/1977 ECOLYZER CARBOXIMETER IADEC, INC.
K770316 03/30/1977 ALKALINE PHOSPHATASE ENZYMATIC ICN PHARMACEUTICALS, INC.
K770311 03/30/1977 GLUCOSE REAGENT, ENZYMATIC ICN PHARMACEUTICALS, INC.
K770317 03/30/1977 GLUCOSE TRINDER, ENZYMATIC ICN PHARMACEUTICALS, INC.
K770314 03/30/1977 REAGENT GPT, ENZYME ICN PHARMACEUTICALS, INC.
K770353 03/16/1977 DISPOSABLE TEMPERATURE PROBE INHAL-O-TECH MEDICAL PLASTIC
K770354 03/16/1977 TUBING, AEROSAL, DISPOSABLE INHAL-O-TECH MEDICAL PLASTIC
K770549 03/30/1977 PEDIATRIC ANESTHESIA CIRCUIT INSPIRON CORP.
K770357 03/01/1977 SPHYGMOMANOMETER, ELECTRONIC ISHIMOTO TRADING CO.
K770076 03/22/1977 BIO-DYES FORT. WRIGHTS STAIN HEMAT. PACK JACK W. KINDBERG
K770074 03/22/1977 BIO-DYES FORTIFIED HEMATOLOGY STAIN JACK W. KINDBERG
K770075 03/22/1977 BIO-DYES HEMATOLOGY PHOSPHATE JACK W. KINDBERG
K770562 03/24/1977 HANDLER CATHETER JANET BEACH, LTD.
K770119 03/14/1977 I.V. LOK TM JELCO LABORATORIES
K770370 03/16/1977 CONVENIENCE TRAY JOHANNAH MEDICAL SERVICES, INC.
K770081 03/09/1977 BAND-AID BRAND OF ADHESIVE BANDAGES JOHNSON & JOHNSON PROFESSIONALS, INC.
K761321 03/21/1977 VITAMIN B12 RADIOASSAY KALLESTAD LABORATORIES, INC.
K770294 03/30/1977 PORT-A-BATH KATHCO, INC.
K770484 03/21/1977 FLUOR. CONJUGATED ANTISERUM KENT LABORATORIES, INC.
K770333 03/01/1977 FLUOROSCOPE, C-ARM LITTON MEDICAL SYSTEMS
K770337 03/01/1977 FLUOROSCOPIC ASSEMBLY, IMAGE INTENS. LITTON MEDICAL SYSTEMS
K770334 03/01/1977 TILTING X-RAY TABLE LITTON MEDICAL SYSTEMS
K770338 03/01/1977 X-RAY CONTROL & X-RAY HV GENERATOR LITTON MEDICAL SYSTEMS
K770336 03/01/1977 X-RAY TUBE, ROTATING ANODE LITTON MEDICAL SYSTEMS
K760047 03/01/1977 TRAY, BLADDER IRRIGATION M-C IND., INC.
K760048 03/01/1977 TRAY, URETHRAL CATHETERIZATION M-C IND., INC.
K770553 03/24/1977 AUDIOMETER, DIAG., ADVANCED, MA-22 MAICO HEARING INSTRUMENTS, INC.
K770373 03/02/1977 HEARING AID, MAICO DB-POWER MAICO HEARING INSTRUMENTS, INC.
K770396 03/23/1977 DRAPES, MODESTY MARK ONE HEALTHCARE PRODUCTS
K760674 03/10/1977 SYN-O-SCOPE NASAL INHALER MCDONALD AND ASSOC., INC.
K770432 03/16/1977 MICROFLUSH MEDEX, INC.
K770320 03/16/1977 URINARY DRAINAGE SET, CLOSED, STERILE MEDICAL DEVICES, INC.
K770552 03/30/1977 CATHETER, KIDNEY DIALYSIS, HEMO-CATH II MEDICAL DISPOSABLES INTL., INC.
K770374 03/30/1977 STYLETTE, SLICK, CAT. NO. 2000B MEDICAL PRODUCTS DIV. P.O.L.A. PLASTI
K770092 03/01/1977 HERPESIVIRUS TEST (TYPE L & 2) MICROBIOLOGICAL RESEARCH CORP.
K761306 03/21/1977 CLINILAB AUTOMATED URINALYSIS SYSTEM MILES LABORATORIES, INC.
K761062 03/07/1977 HISTO-TEK W/ AUTOMATIC COVERSLIPPER MILES LABORATORIES, INC.
K761310 03/21/1977 MEGA-DIASTIX MILES LABORATORIES, INC.
K770299 03/16/1977 TYGON M-60/TYGON M-70 NORTON PERFORMANCE PLASTICS CORP.
K770411 03/16/1977 DIGI TROL TM-RX & DIGI TROL TM-TX NUCLEAR MEDICAL LABORATORIES, INC.
K770466 03/28/1977 STOCKINGS, RVS TM PARKE-DAVIS CO.
K770573 03/30/1977 ACTA-SCANNER R 0200FS PFIZER MEDICAL SYSTEMS, INC.
K770489 03/21/1977 CATHETER WITH HARD VALVE PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K770490 03/21/1977 DRAINAGE BAG, IMPROVED, FLAT PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K770108 03/10/1977 TUBE HOLDING DEVICE PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K770112 03/14/1977 SPECIMEN COLLECTOR PORTEX, INC.
K770391 03/07/1977 COVER, ARMBOARD, DISPOSABLE PRECEPT, INC.
K770463 03/23/1977 MASK, SURGICAL, FACE, DISPOSABLE PRECEPT, INC.
K770402 03/10/1977 RADIOEAR MODEL 1072 RADIOEAR CORP.
K770524 03/30/1977 TRANSDUCER PROTECTOR, RT-901, RT-902 RENAL SYSTEMS, INC.
K770066 03/30/1977 TIBIAL COMPRESSION FRAM FOR FRACTURES RICHARD F. KRONNER, M.D.
K770378 03/09/1977 LAPAROSCOPE, FIBER LIGHT, PALMER-JACOBS RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K770349 03/07/1977 RIGID TEACHING ATTACHMENT RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K770379 03/09/1977 TROCAR SLEEVE SYSTEM RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K770348 03/08/1977 TROCAR SLEEVE SYSTEM, EXTENDED RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K770248 03/09/1977 ARGYLE RAPID GASTRIC LAVAGE KIT SHERWOOD MEDICAL INDUSTRIES
K770512 03/30/1977 CANNULA, INTRAVENOUS, "R" SHERWOOD MEDICAL INDUSTRIES
K770260 03/07/1977 CAP, CLARION NURSES OR (TECHNIC) SHERWOOD MEDICAL INDUSTRIES
K770258 03/07/1977 CAP, CLARION NURSES, STYLE BOUFFANT 21 SHERWOOD MEDICAL INDUSTRIES
K770259 03/07/1977 CAP, CLARION SURGEON'S SHERWOOD MEDICAL INDUSTRIES
K770477 03/30/1977 CITADEL REFERENCE ELECTRODE SHERWOOD MEDICAL INDUSTRIES
K770261 03/01/1977 HOOD, CLARION SURGEONS SHERWOOD MEDICAL INDUSTRIES
K770355 03/08/1977 PIPETTOR W/DETIPPER SHERWOOD MEDICAL INDUSTRIES
K770442 03/30/1977 SUMP DRAIN, W/FILTER, ARGYLE EDLICH SHERWOOD MEDICAL INDUSTRIES
K770388 03/14/1977 FRACTURE REDUCTION SYS., MODEL OR 1001 SISAN ASSOC.
K761350 03/15/1977 MYOTRON SOMATRONICS, INC.
K770447 03/15/1977 EPC INSTICKS STIMULATION TECHNOLOGY, INC.
K770448 03/15/1977 INS - T.E.N.S. STIMULATION TECHNOLOGY, INC.
K770300 03/30/1977 COLON IRRIGATION DEV.,COLON-A-SUN COLONI SUN PRODUCT DIST., INC.
K770250 03/07/1977 GOWN, SURGICAL, SURGINE SURGIKOS, INC.
K770405 03/10/1977 OVERLOAD WARNING DEVICE SYNTHES (USA)
K761329 03/21/1977 MT II SYSTEM - SERUM ALBUMIN TECHNICON INSTRUMENTS CORP.
K770422 03/16/1977 CATHETER, SURFLO, I.V. TERUMO AMERICA, INC.
K770288 03/10/1977 SPECTROPHOTOMETER, MODEL 597 IR THE PERKIN-ELMER CORP.
K770278 03/10/1977 SPECTROPHOTOMETERS, INFRARED MODELS X99 THE PERKIN-ELMER CORP.
K770345 03/08/1977 X-RAY TUBE - "PANOBEAM" THORO-RAY, INC.
K770424 03/16/1977 OXYGEN TWMER, MODEL SST TIMETER INSTRUMENT CORP.
K770107 03/22/1977 SERI-SEP TORVAL CORP.
K770475 03/16/1977 PRESSURE TRANSDUCER ISOLATER CODE 5ML6L2 TRAVENOL LABORATORIES, S.A.
K770493 03/21/1977 TRAVACATH TRAVENOL LABORATORIES, S.A.
K770571 03/30/1977 TRAY, ANESTHESIA, EPIDURAL, CONTINUOUS TRAVENOL LABORATORIES, S.A.
K770193 03/01/1977 PIPETTOR, 400, CENTRIFICHEM SYSTEM UNIVERSAL INSTRUMENTS CORP.
K760851 03/10/1977 CONVERSE ALTAR RETRACTOR V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K770350 03/08/1977 DIALYSIS DELIVERY SYS., ULTIM. MODEL II VITAL SYSTEMS, INC.
K770399 03/09/1977 VALVE FOR CLOSED SYS. URINARY DRAINAGE WILL ROSS CO.
K770545 03/24/1977 DURA-VAC WILLIAMS GOLD REFINING CO., INC.
K770407 03/15/1977 SHIELD, DENTAL X-RAY, PROTECTIVE WORLDWIDE DENTAL, INC.
K770277 03/01/1977 CHOLESTEROL STANDARDS WORTHINGTON BIOCHEMICAL CORP.


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