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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 K913181
Device Name AUTOLOGOUS BLOOD PROCESSING SYSTEM
Original Applicant
LIFESTREAM INT'L, INC.
2828 n.crescent river dr.
the woodlands,  TX  77381
Original Contact lucas gordon
Regulation Number868.5830
Classification Product Code
CAC  
Date Received07/18/1991
Decision Date 05/20/1992
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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