The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresenius Optiflux 200a.
| Device ID | K003498 |
| 510k Number | K003498 |
| Device Name: | FRESENIUS OPTIFLUX 200A |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02173 |
| Contact | Arthur Eilinsfeld |
| Correspondent | Arthur Eilinsfeld FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02173 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-13 |
| Decision Date | 2001-01-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840861100108 | K003498 | 000 |
| 10840861100092 | K003498 | 000 |