The following data is part of a premarket notification filed by Amicon, Inc. with the FDA for Amicon Diafilter Hemofilter.
| Device ID | K863823 |
| 510k Number | K863823 |
| Device Name: | AMICON DIAFILTER HEMOFILTER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | AMICON, INC. 17 CHERRY HILL DR. Danvers, MA 01923 |
| Contact | James M Delaney |
| Correspondent | James M Delaney AMICON, INC. 17 CHERRY HILL DR. Danvers, MA 01923 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-30 |
| Decision Date | 1986-11-06 |