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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Defoamer, Cardiopulmonary Bypass
510(k) Number K902437
Device Name COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER
Applicant
Cobe Laboratories, Inc.
14401 W. 56th Way
Arvada,  CO  80004
Applicant Contact L ARMSTRONG
Correspondent
Cobe Laboratories, Inc.
14401 W. 56th Way
Arvada,  CO  80004
Correspondent Contact L ARMSTRONG
Regulation Number870.4230
Classification Product Code
DTP  
Date Received06/04/1990
Decision Date 12/17/1990
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
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