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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 K955010
Device Name AUTOVAC BP SYSTE, 2000 SERIES
Original Applicant
BOEHRINGER LABORATORIES
500 e. washington st.
norristown,  PA  19401
Original Contact john karpowicz
Regulation Number868.5830
Classification Product Code
CAC  
Date Received11/01/1995
Decision Date 06/20/1996
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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