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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 K853791
Device Name NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000
Applicant
Norton Performance Plastics Corp.
P.O. Box 3660
Akron,  OH  44309
Applicant Contact CHRISTINE D ENGER
Correspondent
Norton Performance Plastics Corp.
P.O. Box 3660
Akron,  OH  44309
Correspondent Contact CHRISTINE D ENGER
Regulation Number870.4240
Classification Product Code
DTR  
Date Received09/11/1985
Decision Date 12/09/1985
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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