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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 K895297
Device Name AUTOTRANSFUSION RESERVIOR MODEL 7900 MODIFICATION
Original Applicant
BOEHRINGER LABORATORIES
p.o. box 870
norristown,  PA  19404
Original Contact john karpowicz
Regulation Number868.5830
Classification Product Code
CAC  
Date Received08/25/1989
Decision Date 03/13/1990
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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