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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory Equipment, Cardiopulmonary Bypass
510(k) Number K851077
Device Name CARDIAC COOLING JACKET
Applicant
Pat O. Daily
7930 Frost St.
Suite 305
San Diego,  CA  92123
Applicant Contact TOM STEINKE
Correspondent
Pat O. Daily
7930 Frost St.
Suite 305
San Diego,  CA  92123
Correspondent Contact TOM STEINKE
Regulation Number870.4200
Classification Product Code
KRI  
Date Received03/18/1985
Decision Date 07/11/1985
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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