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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 K901138
Device Name AUTOVAC(R) AUTOTRANSFUSION SYSTEM, 7900 SERIES
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
Correspondent Contact KARPOWICZ, M.E.
Regulation Number868.5830
Classification Product Code
CAC  
Date Received03/12/1990
Decision Date 06/18/1990
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
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