Device Classification Name |
Subsystem, Proportioning
|
510(k) Number |
K043436 |
Device Name |
NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 |
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 | 876.5820 |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/13/2004 |
Decision Date | 03/17/2005 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|