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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 K040255
Device Name POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE
Applicant
Gambro Renal Products, Inc.
10810 W Collins Ave.
Lakewood,  CO  80215
Applicant Contact JEAN WILLEY
Correspondent
Gambro Renal Products, Inc.
10810 W Collins Ave.
Lakewood,  CO  80215
Correspondent Contact JEAN WILLEY
Regulation Number876.5860
Classification Product Code
KDI  
Subsequent Product Code
FJI  
Date Received02/04/2004
Decision Date 05/24/2004
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
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