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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dialyzer, high permeability with or without sealed dialysate system
510(k) Number K841585
Device Name AMER. BENTLEY CONTINU-BLOOD PROCESSOR-
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 Number876.5860
Classification Product Code
KDI  
Date Received04/17/1984
Decision Date 10/18/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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