Device Classification Name |
dialysate concentrate for hemodialysis (liquid or powder)
|
510(k) Number |
K011368 |
Device Name |
DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS |
Applicant |
GAMBRO RENAL PRODUCTS |
1845 MASON AVE. |
DAYTONA BEACH,
FL
32117 -5102
|
|
Applicant Contact |
FEI LAW |
Correspondent |
GAMBRO RENAL PRODUCTS |
1845 MASON AVE. |
DAYTONA BEACH,
FL
32117 -5102
|
|
Correspondent Contact |
FEI LAW |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 05/04/2001 |
Decision Date | 08/02/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|