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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00896241002732 | K110285 | 000 |
| 10896241002227 | K110285 | 000 |
| 10896241002210 | K110285 | 000 |
| 10896241002203 | K110285 | 000 |
| 10896241002135 | K110285 | 000 |
| 10896241002128 | K110285 | 000 |
| 20866318000378 | K110285 | 000 |
| 20866318000361 | K110285 | 000 |
| 20866318000354 | K110285 | 000 |
| 00896241002237 | K110285 | 000 |
| 00896241002244 | K110285 | 000 |
| 20896241002675 | K110285 | 000 |
| 20896241002668 | K110285 | 000 |
| 10896241002623 | K110285 | 000 |
| 10896241002616 | K110285 | 000 |
| 10896241002593 | K110285 | 000 |
| 10896241002517 | K110285 | 000 |
| 10896241002500 | K110285 | 000 |
| 10896241002258 | K110285 | 000 |
| 10866318000302 | K110285 | 000 |