The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Modification To: Lifemate Hemofiltration System.
| Device ID | K012510 |
| 510k Number | K012510 |
| Device Name: | MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-06 |
| Decision Date | 2001-10-19 |
| Summary: | summary |