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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 K924894
Device Name AUTOVAC 7900 SERIES
Original Applicant
p.o. box 870
norristown,  PA  19404
Original Contact john karpowicz
Regulation Number868.5830
Classification Product Code
Date Received09/28/1992
Decision Date 02/05/1993
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No