Device Classification Name |
dialysate concentrate for hemodialysis (liquid or powder)
|
510(k) Number |
K072908 |
Device Name |
PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY |
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 | 10/12/2007 |
Decision Date | 02/04/2008 |
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
|