Device Classification Name |
Subsystem, Water Purification
|
510(k) Number |
K991916 |
Device Name |
VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
Applicant |
VIRGINIA WATER SYSTEMS, INC. |
7433 WHITEPINE RD. |
RICHMOND,
VA
23237
|
|
Applicant Contact |
WILLIAM G GARRAHAN |
Correspondent |
VIRGINIA WATER SYSTEMS, INC. |
7433 WHITEPINE RD. |
RICHMOND,
VA
23237
|
|
Correspondent Contact |
WILLIAM G GARRAHAN |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 06/07/1999 |
Decision Date | 01/14/2000 |
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
|
|
|