ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS


Device Classification Name

dialysate concentrate for hemodialysis (liquid or powder)

510(k) Number K954527
Device Name ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS
Applicant
ROCKWELL MEDICAL SUPPLY
28025 oakland oaks ct.
wixom, 
MI 
48393

Applicant Contact jeffrey r shiderman
Correspondent
ROCKWELL MEDICAL SUPPLY
28025 oakland oaks ct.
wixom, 
MI 
48393

Correspodent Contact jeffrey r shiderman
Regulation Number 876.5820
Classification Product Code
KPO  
Date Received 09/29/1995
Decision Date 03/01/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls