The following data is part of a premarket notification filed by Nephros, Inc. with the FDA for Nephros Dsu Filter, Nephros Msu Filter, Nephros Ssu Filter.
| Device ID | K110285 |
| 510k Number | K110285 |
| Device Name: | NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER |
| Classification | Subsystem, Water Purification |
| Applicant | NEPHROS, INC. 41 GRAND AVE. River Edge, NJ 07661 |
| Contact | James Summerton |
| Correspondent | James Summerton NEPHROS, INC. 41 GRAND AVE. River Edge, NJ 07661 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-31 |
| Decision Date | 2011-07-14 |