Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K122051 |
Device Name |
NXSTAGE SYSTEM ONE |
Applicant |
NXSTAGE MEDICAL, INC. |
350 Merrimack St |
LAWRENCE,
MA
01843
|
|
Applicant Contact |
MARY LUO STROUMBOS |
Correspondent |
NXSTAGE MEDICAL, INC. |
350 Merrimack St |
LAWRENCE,
MA
01843
|
|
Correspondent Contact |
MARY LUO STROUMBOS |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 07/12/2012 |
Decision Date | 04/23/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|