The following data is part of a premarket notification filed by Nephros, Inc. with the FDA for Nephros, Inc., Dsu Dual Stage Ultrafilter.
| Device ID | K090885 |
| 510k Number | K090885 |
| Device Name: | NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER |
| Classification | Subsystem, Water Purification |
| Applicant | NEPHROS, INC. 41 GRAND AVE. SUITE 201 River Edge, NJ 07661 |
| Contact | Vikki M O'connor |
| Correspondent | Vikki M O'connor NEPHROS, INC. 41 GRAND AVE. SUITE 201 River Edge, NJ 07661 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-31 |
| Decision Date | 2009-06-29 |
| Summary: | summary |