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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microfilter, Blood Transfusion
510(k) Number K812874
Device Name PEDIATRIC MICROAGGREGATE BLOOD FILTER
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Regulation Number880.5440
Classification Product Code
CAK  
Date Received10/14/1981
Decision Date 11/02/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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