The following data is part of a premarket notification filed by Nephros with the FDA for Hdf Assist Mudule, Hdf Infusion Set And Substitution Filter.
| Device ID | K210575 |
| 510k Number | K210575 |
| Device Name: | HDF Assist Mudule, HDF Infusion Set And Substitution Filter |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | Nephros 380 Lackawanna Place South Orange, NJ 07079 |
| Contact | Vashone R Thomas |
| Correspondent | Vashone R Thomas Nephros 380 Lackawanna Place South Orange, NJ 07079 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-26 |
| Decision Date | 2022-05-13 |