The following data is part of a premarket notification filed by Nephros Inc. with the FDA for Endopur Filter.
| Device ID | K161304 |
| 510k Number | K161304 |
| Device Name: | EndoPur Filter |
| Classification | Subsystem, Water Purification |
| Applicant | Nephros Inc. 41 Grand Ave River Edge, NJ 07661 |
| Contact | Hollie Johnson |
| Correspondent | Hollie Johnson Nephros Inc. 41 Grand Ave 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 | 2016-05-10 |
| Decision Date | 2017-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 02086827700062 | K161304 | 000 |
| 10896241002685 | K161304 | 000 |
| 10868277000447 | K161304 | 000 |
| 10868277000454 | K161304 | 000 |
| 10868277000416 | K161304 | 000 |
| 10868277000423 | K161304 | 000 |
| 20868277000437 | K161304 | 000 |
| 02086827700048 | K161304 | 000 |
| 01086827700056 | K161304 | 000 |
| 10866318000388 | K161304 | 000 |