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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 K993064
Device Name PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
Applicant
Gambro Renal Care Products
1185 Oak St.
Lakewood,  CO  80215
Applicant Contact WILLIAM M TOWNSEND
Correspondent
Gambro Renal Care Products
1185 Oak St.
Lakewood,  CO  80215
Correspondent Contact WILLIAM M TOWNSEND
Regulation Number876.5860
Classification Product Code
KDI  
Date Received09/13/1999
Decision Date 10/06/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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