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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 K920273
Device Name HEMOVAC AUTOTRANSFUSION SYSTEM
Applicant
ZIMMER PATIENT CARE DIVISION
200 W. OHIO AVE.
P.O. BOX 10
DOVER,  OH  44622
Applicant Contact PAULA S OSORIO
Correspondent
ZIMMER PATIENT CARE DIVISION
200 W. OHIO AVE.
P.O. BOX 10
DOVER,  OH  44622
Correspondent Contact PAULA S OSORIO
Regulation Number868.5830
Classification Product Code
CAC  
Date Received01/22/1992
Decision Date 01/28/1993
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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