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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, autotransfusion
510(k) Number K901138
Device Name AUTOVAC(R) AUTOTRANSFUSION SYSTEM, 7900 SERIES
Original Applicant
BOEHRINGER LABORATORIES
p.o. box 870
norristown,  PA  19404
Original Contact karpowicz, m.e.
Regulation Number868.5830
Classification Product Code
CAC  
Date Received03/12/1990
Decision Date 06/18/1990
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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