The following data is part of a premarket notification filed by Fresenius Medical Care with the FDA for Fresenius 2008k.
| Device ID | K994267 |
| 510k Number | K994267 |
| Device Name: | FRESENIUS 2008K |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | FRESENIUS MEDICAL CARE TWO LEDGEMONT CENTER 95 HAYDEN AVENUE Lexington, MA 02420 |
| Contact | Arthur Eilinsfeld |
| Correspondent | Arthur Eilinsfeld FRESENIUS MEDICAL CARE TWO LEDGEMONT CENTER 95 HAYDEN AVENUE Lexington, MA 02420 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-17 |
| Decision Date | 2000-03-16 |
| Summary: | summary |