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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 K830014
Device Name HEMA - NV TRANS. BLOOD FILTER 100/800
Original Applicant
one abbott park rd.
abbott park,  IL  60064 -3500
Regulation Number880.5440
Classification Product Code
Date Received01/03/1983
Decision Date 01/17/1983
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls