The following data is part of a premarket notification filed by Althin Medical Ab with the FDA for Af-180 Hemodialyzer.
| Device ID | K992564 |
| 510k Number | K992564 |
| Device Name: | AF-180 HEMODIALYZER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | ALTHIN MEDICAL AB FRIDHEMSVAGEN 15 Ronneby, SE S-37221 |
| Contact | Lars-olof Sandberg |
| Correspondent | Lars-olof Sandberg ALTHIN MEDICAL AB FRIDHEMSVAGEN 15 Ronneby, SE S-37221 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-02 |
| Decision Date | 2000-01-18 |
| Summary: | summary |