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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 K854113
Device Name CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH
Applicant
American Bentley
17502 Armstrong Ave.
Irvine,  CA  92714
Applicant Contact DONALD A RAIBLE
Correspondent
American Bentley
17502 Armstrong Ave.
Irvine,  CA  92714
Correspondent Contact DONALD A RAIBLE
Regulation Number870.4200
Classification Product Code
KRI  
Date Received10/08/1985
Decision Date 01/08/1986
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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