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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 K802674
Device Name RESERVOIR FOR AUTOLOGOUS BLOOD TRANSFUS.
Applicant
HAEMONETICS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HAEMONETICS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5830
Classification Product Code
CAC  
Date Received10/27/1980
Decision Date 01/08/1981
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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