GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K010667
Device Name GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R
Original Applicant
GAMBRO RENAL PRODUCTS
10810 w. collins ave.
lakewood, 
CO 
80215

Original Contact jeffrey r shideman
Regulation Number 876.5860
Classification Product Code
KDI  
Subsequent Product Code
MSF  
Date Received 03/06/2001
Decision Date 06/04/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No