The following data is part of a premarket notification filed by Medica S.r.l. with the FDA for Medica Hp 300 Hemofiltration Pump, Model 300.
| Device ID | K000724 |
| 510k Number | K000724 |
| Device Name: | MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | MEDICA S.R.L. 100 MAIN ST. SUITE 120 Concord, MA 01742 |
| Contact | James Delaney |
| Correspondent | James Delaney MEDICA S.R.L. 100 MAIN ST. SUITE 120 Concord, MA 01742 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-06 |
| Decision Date | 2001-03-22 |