The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Lifemate Mla Multi-line Adaptor; Lifemate Sfr Sterile Fluid Reservoir.
| Device ID | K011269 |
| 510k Number | K011269 |
| Device Name: | LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST. SUITE 501 S. Lawrence, MA 01843 |
| Contact | Karen St. Onge |
| Correspondent | Karen St. Onge NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST. SUITE 501 S. 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 | 2001-04-26 |
| Decision Date | 2002-03-04 |