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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 (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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