DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE


Device Classification Name

dialysate concentrate for hemodialysis (liquid or powder)

510(k) Number K022500
Device Name DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE
Original Applicant
ROCKWELL MEDICAL TECHNOLOGIES, INC.
30142 wixom rd.
wixom, 
MI 
48393

Original Contact donald danald
Regulation Number 876.5820
Classification Product Code
KPO  
Date Received 07/29/2002
Decision Date 12/23/2002
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