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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
Recalls CDRH Recalls
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