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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.
PO BOX 10 200 W. OHIO AVENUE
DOVER,  OH  44622 -0010
Applicant Contact CINDY J DICKEY
Correspondent
ZIMMER, INC.
PO BOX 10 200 W. OHIO AVENUE
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
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