The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresenius Optiflux F20nr, Ff18nr, F16nr.
| Device ID | K043244 |
| 510k Number | K043244 |
| Device Name: | FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02420 -9192 |
| Contact | Arthur Eilinsfeld |
| Correspondent | Arthur Eilinsfeld FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02420 -9192 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-23 |
| Decision Date | 2004-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840861100085 | K043244 | 000 |
| 10840861100078 | K043244 | 000 |