The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresnius Hemoflow F7nr, F50nr, F70nr Hemodialyzers.
| Device ID | K002761 |
| 510k Number | K002761 |
| Device Name: | FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| 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 | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-05 |
| Decision Date | 2000-12-04 |