Device Classification Name |
Subsystem, Proportioning
|
510(k) Number |
K080919 |
Device Name |
NXSTAGE PUREFLOW SL |
Applicant |
NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST., 5TH FLOOR |
LAWRENCE,
MA
01843
|
|
Applicant Contact |
MICHAEL DOYLE |
Correspondent |
NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST., 5TH FLOOR |
LAWRENCE,
MA
01843
|
|
Correspondent Contact |
MICHAEL DOYLE |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 04/01/2008 |
Decision Date | 10/15/2008 |
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 |
Yes
|
Recalls |
CDRH Recalls
|
|
|