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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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flowguard catheters & cannalae Advocacy International, Ltd. k813037 12/14/1981
model 5867-12 bipolar low-profile lead Medtronic Vascular k812725 11/16/1981
guinea pig blood in alsever's, cit., def Dutchland Laboratories, Inc. k812372 09/09/1981
legionella indirect fluor. antibody Centers For Disease Control and Prevention k812007 09/08/1981
powered wheelchair The Oec Group k811656 06/25/1981
sim medium Acumedia Manufacturers, Inc. k811330 05/29/1981
bcd-hpp41c interface Dynatech Corp. k810968 04/23/1981
hoffman hoop device Howmedica Corp. k810644 03/24/1981
femoral canal brush Richard'S Medical Equip., Inc. k810267 02/09/1981
sensomat muscle/tissue ph Biochem International, Inc. k803260 02/02/1981

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