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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 K952532
Device Name AFFINITY ARTERIAL BLOOD FILTER
Applicant
Avecor Cardiovascular, Inc.
13010 Country Rd. 6
Plymouth,  MN  55441
Applicant Contact DENNIS E STEGER
Correspondent
Avecor Cardiovascular, Inc.
13010 Country Rd. 6
Plymouth,  MN  55441
Correspondent Contact DENNIS E STEGER
Regulation Number870.4260
Classification Product Code
DTM  
Date Received06/01/1995
Decision Date 10/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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