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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name heat-exchanger, cardiopulmonary bypass
510(k) Number K012898
Device Name MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
Applicant
COBE CARDIOVASCULAR, INC.
14401 WEST 65TH WAY
ARVADA,  CO  80004
Applicant Contact LYNNE LEONARD
Correspondent
COBE CARDIOVASCULAR, INC.
14401 WEST 65TH WAY
ARVADA,  CO  80004
Correspondent Contact LYNNE LEONARD
Regulation Number870.4240
Classification Product Code
DTR  
Date Received08/29/2001
Decision Date 09/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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