The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Nxstage 1.6m2 Dialyzer.
| Device ID | K131050 |
| 510k Number | K131050 |
| Device Name: | NXSTAGE 1.6M2 DIALYZER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | NXSTAGE MEDICAL, INC. 350 Merrimack St Lawrence, MA 01843 |
| Contact | Nnamdi Nwachukwu |
| Correspondent | Nnamdi Nwachukwu NXSTAGE MEDICAL, INC. 350 Merrimack St Lawrence, MA 01843 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-15 |
| Decision Date | 2013-12-27 |
| Summary: | summary |