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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K913956
Device Name BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30
Applicant
Bentley Laboratories, Inc.
P.O. Bix 19522
Irvine,  CA  92713
Applicant Contact JILL SCHWEIGER
Correspondent
Bentley Laboratories, Inc.
P.O. Bix 19522
Irvine,  CA  92713
Correspondent Contact JILL SCHWEIGER
Regulation Number870.4400
Classification Product Code
DTN  
Date Received09/05/1991
Decision Date 01/17/1992
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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