Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K014152 |
Device Name |
NXSTAGE CARTRIDGE EXPRESS |
Applicant |
NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST. |
SUITE 501 |
LAWRENCE,
MA
01843
|
|
Applicant Contact |
NORMA LEMAY |
Correspondent |
NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST. |
SUITE 501 |
LAWRENCE,
MA
01843
|
|
Correspondent Contact |
NORMA LEMAY |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 12/18/2001 |
Decision Date | 12/11/2002 |
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
|
|
|