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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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catheter-thru-needle device Abbott Laboratories k770403 03/16/1977
surg. scissors for cutting tissue Depuy, Inc. k771743 09/26/1977
arrhythmia program module Midwest Analog & Digital, Inc. k780432 05/26/1978
ms-2 bacterial id. system Abbott Laboratories k781427 09/27/1978
isolation sleeve, model 346-01 Intermedics, Inc. k790101 01/24/1979
cover gard Fem-Gard, Inc. k790955 06/20/1979
glucose hexokinase coil reagent system Fisher Scientific Co., LLC k791760 09/27/1979
pneupac resuscitator instant action set Pneupac , Ltd. k792451 02/05/1980
paracontrol abnormal immunoglobulin cont Diagnostica, Inc. k800398 03/12/1980
3m steam sterilization indicator 3M Company k801057 06/17/1980

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