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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 K932093
Device Name AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S
Original Applicant
BOEHRINGER LABORATORIES
p.o. box 870
norristown,  PA  19404
Original Contact john karpowicz
Regulation Number868.5830
Classification Product Code
CAC  
Date Received04/30/1993
Decision Date 07/06/1994
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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