GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR


Device Classification Name

hemodialyzer, re-use, high flux

510(k) Number K023615
Device Name GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR
Original Applicant
GAMBRO RENAL PRODUCTS
10810 w. collins ave.
lakewood, 
CO 
80215

Original Contact jeffrey r shideman
Regulation Number 876.5860
Classification Product Code
MSF  
Date Received 10/28/2002
Decision Date 05/06/2003
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