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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 K945775
Device Name BOEHRINGER AUTOVAC(R) 7900 SERIES
Original Applicant
BOEHRINGER LABORATORIES
p.o. box 870
norristown,  PA  19404
Original Contact john karpowicz
Regulation Number868.5830
Classification Product Code
CAC  
Date Received11/25/1994
Decision Date 10/19/1995
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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