Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K121497 |
Device Name |
VENOFER PUMP |
Applicant |
RENAL SOLUTIONS INC. |
770 COMMONWEALTH DRIVE |
SUITE 101 |
WARRENDALE,
PA
15086
|
|
Applicant Contact |
DAVID VANELLA |
Correspondent |
RENAL SOLUTIONS INC. |
770 COMMONWEALTH DRIVE |
SUITE 101 |
WARRENDALE,
PA
15086
|
|
Correspondent Contact |
DAVID VANELLA |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 05/21/2012 |
Decision Date | 08/17/2012 |
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
|
|
|