Device Classification Name |
dialysate concentrate for hemodialysis (liquid or powder)
|
510(k) Number |
K012328 |
Device Name |
HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER |
Applicant |
DI-CHEM, INC. |
12297 ENSIGN AVE. NORTH |
CHAMPLIN,
MN
55316
|
|
Applicant Contact |
KEITH A BUCHHOLZ |
Correspondent |
DI-CHEM, INC. |
12297 ENSIGN AVE. NORTH |
CHAMPLIN,
MN
55316
|
|
Correspondent Contact |
KEITH A BUCHHOLZ |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 07/23/2001 |
Decision Date | 01/18/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|