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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 K931967
Device Name HE-30 GOLD
Applicant
Bentley Laboratories, Inc.
P.O. Bix 19522
Irvine,  CA  92713
Applicant Contact PAUL J ZALESKY
Correspondent
Bentley Laboratories, Inc.
P.O. Bix 19522
Irvine,  CA  92713
Correspondent Contact PAUL J ZALESKY
Regulation Number870.4240
Classification Product Code
DTR  
Date Received04/21/1993
Decision Date 07/13/1993
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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