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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 K896974
Device Name CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120
Applicant
DAILY MEDICAL PRODUCTS, INC.
3665 KEARNY VILLA RD.
STE 301
SAN DIEGO,  CA  92123
Applicant Contact ALAN SECORD
Correspondent
DAILY MEDICAL PRODUCTS, INC.
3665 KEARNY VILLA RD.
STE 301
SAN DIEGO,  CA  92123
Correspondent Contact ALAN SECORD
Regulation Number870.4250
Classification Product Code
DWC  
Date Received12/13/1989
Decision Date 02/05/1990
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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