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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Blood, Cardiopulmonary Bypass, Arterial Line
510(k) Number K994208
Device Name AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354
Applicant
Medtronic Perfusion Systems
7611 Northland Dr.
Minneapolis,  MN  55038
Applicant Contact MARIE HOLM
Correspondent
Medtronic Perfusion Systems
7611 Northland Dr.
Minneapolis,  MN  55038
Correspondent Contact MARIE HOLM
Regulation Number870.4260
Classification Product Code
DTM  
Date Received12/14/1999
Decision Date 01/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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