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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 K041525
Device Name HEMOVAC BLOOD REINFUSION SYSTEM
Applicant
Zimmer, Inc.
P.O. Box 10 200 W. Ohio Ave.
Dover,  OH  44622 -0010
Applicant Contact CINDY J DICKEY
Correspondent
Zimmer, Inc.
P.O. Box 10 200 W. Ohio Ave.
Dover,  OH  44622 -0010
Correspondent Contact CINDY J DICKEY
Regulation Number868.5830
Classification Product Code
CAC  
Date Received06/08/2004
Decision Date 10/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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