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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 K903641
Device Name QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q
Applicant
Bentley Laboratories, Inc.
P.O. Bix 19522
Irvine,  CA  92713
Applicant Contact DONALD RAILBE
Correspondent
Bentley Laboratories, Inc.
P.O. Bix 19522
Irvine,  CA  92713
Correspondent Contact DONALD RAILBE
Regulation Number876.5860
Classification Product Code
KDI  
Date Received08/14/1990
Decision Date 11/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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