Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K080650 |
Device Name |
OMNI-DL SYSTEM |
Applicant |
TRANSVIVO INC. |
3067 RESEARCH DRIVE |
RICHMOND,
CA
94806
|
|
Applicant Contact |
J. MICHAEL DELMAGE |
Correspondent |
TRANSVIVO INC. |
3067 RESEARCH DRIVE |
RICHMOND,
CA
94806
|
|
Correspondent Contact |
J. MICHAEL DELMAGE |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 03/07/2008 |
Decision Date | 11/26/2008 |
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
|
|
|