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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 K881129
Device Name AUTO-VAC INTRAOPERATIVE AUTOTRANS. RESERVOIR #7904
Applicant
BOEHRINGER LABORATORIES
p.o. box 870
norristown,  PA  19404
Applicant Contact karpowicz, m.e.
Correspondent
BOEHRINGER LABORATORIES
p.o. box 870
norristown,  PA  19404
Correspodent Contact karpowicz, m.e.
Regulation Number868.5830
Classification Product Code
CAC  
Date Received03/16/1988
Decision Date 06/14/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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