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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 K920618
Device Name AUTOTRANSFUSION SUCTION SET
Applicant
LIFESTREAM INT'L, INC.
2828 N.CRESCENT RIVER DR.
THE WOODLANDS,  TX  77381
Applicant Contact KRISTA OAKES
Correspondent
LIFESTREAM INT'L, INC.
2828 N.CRESCENT RIVER DR.
THE WOODLANDS,  TX  77381
Correspondent Contact KRISTA OAKES
Regulation Number868.5830
Classification Product Code
CAC  
Date Received02/11/1992
Decision Date 03/12/1993
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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