The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Nxstage Pureflow Sl.
| Device ID | K111174 |
| 510k Number | K111174 |
| Device Name: | NXSTAGE PUREFLOW SL |
| Classification | Subsystem, Proportioning |
| Applicant | NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence, MA 01843 |
| Contact | Mary Lou Stroumbos |
| Correspondent | Mary Lou Stroumbos NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR 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 | 2011-04-27 |
| Decision Date | 2011-09-19 |
| Summary: | summary |