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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 K963203
Device Name BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT
Applicant
Baxter Healthcare Corp
17221 Red Hill Ave.
P.O. 11150
Santa Ana,  CA  92711
Applicant Contact SCOTT BEGGINS
Correspondent
Baxter Healthcare Corp
17221 Red Hill Ave.
P.O. 11150
Santa Ana,  CA  92711
Correspondent Contact SCOTT BEGGINS
Regulation Number876.5860
Classification Product Code
KDI  
Date Received08/15/1996
Decision Date 03/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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