The following data is part of a premarket notification filed by Amicon, Inc. with the FDA for Amicon Minifilter Plus Hemofilter.
| Device ID | K895405 |
| 510k Number | K895405 |
| Device Name: | AMICON MINIFILTER PLUS HEMOFILTER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | AMICON, INC. 17 CHERRY HILL DR. Danvers, MA 01923 |
| Contact | James Delaney |
| Correspondent | James 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 | 1989-09-07 |
| Decision Date | 1990-01-11 |