GAMBRO POLYFLUX, MODEL 140H, 170H, 210H


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K030592
Device Name GAMBRO POLYFLUX, MODEL 140H, 170H, 210H
Applicant
GAMBRO RENAL CARE PRODUCTS
10810 w. collins ave.
lakewood, 
CO 
80215

Applicant Contact jeffrey r schidman
Correspondent
GAMBRO RENAL CARE PRODUCTS
10810 w. collins ave.
lakewood, 
CO 
80215

Correspodent Contact jeffrey r schidman
Regulation Number 876.5860
Classification Product Code
KDI  
Date Received 02/25/2003
Decision Date 05/23/2003
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