The following data is part of a premarket notification filed by Fresenius Medical Care Reanal Therapies Group Llc with the FDA for Optiflux Enexa F500 Dialyzer.
| Device ID | K192928 |
| 510k Number | K192928 |
| Device Name: | Optiflux Enexa F500 Dialyzer |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | Fresenius Medical Care Reanal Therapies Group LLC 920 Winter Street Waltham, MA 02451 |
| Contact | Denise Oppermann |
| Correspondent | Denise Oppermann Fresenius Medical Care Reanal Therapies Group LLC 920 Winter Street Waltham, MA 02451 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-17 |
| Decision Date | 2020-07-09 |