The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Nxstage Pureflow Sl.
| Device ID | K140571 |
| 510k Number | K140571 |
| Device Name: | NXSTAGE PUREFLOW SL |
| Classification | Subsystem, Proportioning |
| Applicant | NXSTAGE MEDICAL, INC. 350 MERRIMACK STREET Lawrence, MA 01843 |
| Contact | Mary L Stroumbos |
| Correspondent | Mary L Stroumbos NXSTAGE MEDICAL, INC. 350 MERRIMACK STREET Lawrence, MA 01843 |
| Product Code | FKR |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-06 |
| Decision Date | 2014-05-15 |
| Summary: | summary |