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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Temperature, Cardiopulmonary Bypass
510(k) Number K896393
Device Name CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620
Applicant
Daily Medical, Inc.
9225 Chesapeake Dr.
Suite D
San Diego,  CA  92123
Applicant Contact ALAN SEACORD
Correspondent
Daily Medical, Inc.
9225 Chesapeake Dr.
Suite D
San Diego,  CA  92123
Correspondent Contact ALAN SEACORD
Regulation Number870.4250
Classification Product Code
DWC  
Date Received11/06/1989
Decision Date 02/02/1990
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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