ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE


Device Classification Name

dialysate concentrate for hemodialysis (liquid or powder)

510(k) Number K023985
Device Name ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE
Original Applicant
ROCKWELL MEDICAL TECHNOLOGIES, INC.
30142 wixom rd.
wixom, 
MI 
48393

Original Contact gerry fritz
Regulation Number 876.5820
Classification Product Code
KPO  
Date Received 12/02/2002
Decision Date 02/28/2003
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