Device Classification Name |
dialysate concentrate for hemodialysis (liquid or powder)
|
510(k) Number |
K022521 |
Device Name |
BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON |
Applicant |
ROCKWELL MEDICAL TECHNOLOGIES, INC. |
30142 WIXOM RD. |
WIXOM,
MI
48393
|
|
Applicant Contact |
DONALD DANALD |
Correspondent |
ROCKWELL MEDICAL TECHNOLOGIES, INC. |
30142 WIXOM RD. |
WIXOM,
MI
48393
|
|
Correspondent Contact |
DONALD DANALD |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 07/30/2002 |
Decision Date | 01/03/2003 |
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
|
Recalls |
CDRH Recalls
|
|
|