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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cpb Check Valve, Retrograde Flow, In-Line
510(k) Number K982406
Device Name COBE VACUUM RELIEF CHECK VALVE
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 Number870.4400
Classification Product Code
MJJ  
Date Received07/10/1998
Decision Date 10/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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