PHOENIX HEMODIALYSIS DELIVERY SYSTEM


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K103832
Device Name PHOENIX HEMODIALYSIS DELIVERY SYSTEM
Applicant
GAMBRO RENAL PRODUCTS, INC.
14143 denver west parkway
suite 400
lakewood, 
CO 
80401

Applicant Contact kae miller
Correspondent
GAMBRO RENAL PRODUCTS, INC.
14143 denver west parkway
suite 400
lakewood, 
CO 
80401

Correspodent Contact kae miller
Regulation Number 876.5860
Classification Product Code
KDI  
Date Received 12/30/2010
Decision Date 05/20/2011
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