The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Lifemate Hemofiltration System.
| Device ID | K001283 |
| 510k Number | K001283 |
| Device Name: | LIFEMATE HEMOFILTRATION SYSTEM |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | NXSTAGE MEDICAL, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Jeffrey Burbank |
| Correspondent | Jeffrey Burbank NXSTAGE MEDICAL, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-21 |
| Decision Date | 2001-01-17 |