The following data is part of a premarket notification filed by Medical Device Consultants, Inc. with the FDA for Amicon Diafilter 40. Hemofilter.
| Device ID | K840449 |
| 510k Number | K840449 |
| Device Name: | AMICON DIAFILTER 40. HEMOFILTER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | MEDICAL DEVICE CONSULTANTS, INC. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-01 |
| Decision Date | 1984-03-23 |