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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 K810855
Device Name INTERFACE 20 MICRON TRANSFUSION BLD. F.
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 Received03/30/1981
Decision Date 04/21/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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