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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 K940678
Device Name AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER
Original Applicant
BAXTER HEALTHCARE CORP.
17511 armstrong ave.
p.o.box 19522
irvine,  CA  92713 9522
Original Contact thomas j humphrey
Regulation Number868.5830
Classification Product Code
CAC  
Date Received02/09/1994
Decision Date 04/15/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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