Device Classification Name |
Subsystem, Water Purification
|
510(k) Number |
K042797 |
Device Name |
WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
Applicant |
GAMBRO RENAL PRODUCTS |
10810 WEST COLLINS AVE. |
LAKEWOOD,
CO
80215
|
|
Applicant Contact |
ROD J RYLANDS |
Correspondent |
GAMBRO RENAL PRODUCTS |
10810 WEST COLLINS AVE. |
LAKEWOOD,
CO
80215
|
|
Correspondent Contact |
ROD J RYLANDS |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 10/08/2004 |
Decision Date | 03/09/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|