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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 K974812
Device Name COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR
Applicant
Cobe Cardiovascular, Inc.
14401 W. 65th Way
Arvada,  CO  80004
Applicant Contact LYNNE LEONARD
Correspondent
Cobe Cardiovascular, Inc.
14401 W. 65th Way
Arvada,  CO  80004
Correspondent Contact LYNNE LEONARD
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received12/23/1997
Decision Date 06/01/1998
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
Recalls CDRH Recalls
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