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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Blood, Cardiopulmonary Bypass, Arterial Line
510(k) Number K842813
Device Name HEPARIN COATED ARTERIAL BLOOD FILTERS
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 Number870.4260
Classification Product Code
DTM  
Date Received07/18/1984
Decision Date 01/08/1985
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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