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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 K014187
Device Name AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM
Original Applicant
BOEHRINGER LABORATORIES
500 e. washington st.
norristown,  PA  19401
Original Contact john karpowicz
Regulation Number868.5830
Classification Product Code
CAC  
Date Received12/21/2001
Decision Date 02/06/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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