CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220

Controller, Temperature, Cardiopulmonary Bypass

DAILY MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Daily Medical Products, Inc. with the FDA for Cardiac Cooling Jacket, 30% Reduced, Model Cj-220.

Pre-market Notification Details

Device IDK896975
510k NumberK896975
Device Name:CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220
ClassificationController, Temperature, Cardiopulmonary Bypass
Applicant DAILY MEDICAL PRODUCTS, INC. 3665 KEARNY VILLA RD. STE 301 San Diego,  CA  92123
ContactAlan Seacord
CorrespondentAlan Seacord
DAILY MEDICAL PRODUCTS, INC. 3665 KEARNY VILLA RD. STE 301 San Diego,  CA  92123
Product CodeDWC  
CFR Regulation Number870.4250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-13
Decision Date1990-02-05

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