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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K964043
Device Name COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS
Applicant
Cobe Cardiovascular, Inc.
14401 W. 65th Way
Arvada,  CO  80004
Applicant Contact MARY L ARMSTRONG
Correspondent
Cobe Cardiovascular, Inc.
14401 W. 65th Way
Arvada,  CO  80004
Correspondent Contact MARY L ARMSTRONG
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received10/09/1996
Decision Date 09/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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