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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 K843983
Device Name MYOCARDIAL INSULATOR
Applicant
Norton Texas Medical Products
10940 S. Wilcrest Dr.
Houston,  TX  77099
Applicant Contact RICK FOSTER
Correspondent
Norton Texas Medical Products
10940 S. Wilcrest Dr.
Houston,  TX  77099
Correspondent Contact RICK FOSTER
Regulation Number870.4240
Classification Product Code
DTR  
Date Received10/11/1984
Decision Date 12/27/1984
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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