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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
Applicant
Boehringer Laboratories
P.O. Box 870
Norristown,  PA  19404
Applicant Contact JOHN KARPOWICZ
Correspondent
Boehringer Laboratories
P.O. Box 870
Norristown,  PA  19404
Correspondent 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 Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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