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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K873923
Device Name INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER
Applicant
American Bentley
P.O. Box 19522
Irvine,  CA  92713
Applicant Contact MERRITT GIRGIS
Correspondent
American Bentley
P.O. Box 19522
Irvine,  CA  92713
Correspondent Contact MERRITT GIRGIS
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received09/25/1987
Decision Date 11/06/1987
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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