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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K936003
Device Name AFFINITY CVR
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 Number870.4400
Classification Product Code
DTN  
Date Received12/16/1993
Decision Date 06/20/1994
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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