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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 K900483
Device Name VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.
Original Applicant
BAXTER HEALTHCARE CORP.
1425 lake cook rd.
deerfield,  IL  60015
Original Contact charles b mcneil
Regulation Number868.5830
Classification Product Code
CAC  
Date Received02/01/1990
Decision Date 08/29/1990
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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