The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Optiflux F250nr, Model 0500325e.
| Device ID | K082414 |
| 510k Number | K082414 |
| Device Name: | OPTIFLUX F250NR, MODEL 0500325E |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451 -1457 |
| Contact | Janet Kay |
| Correspondent | Janet Kay FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451 -1457 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-21 |
| Decision Date | 2008-10-28 |
| Summary: | summary |