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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 K920312
Device Name NEW COBE CARDIOPLEGIA SYSTEM
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 Number870.4400
Classification Product Code
DTN  
Date Received01/23/1992
Decision Date 10/01/1992
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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