The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Filtral 10, Filtral 12, Filtral 16 Hemodialyzer.
| Device ID | K872767 |
| 510k Number | K872767 |
| Device Name: | FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | HOSPAL MEDICAL CORP. 21 NORTHFIELD AVE. RARITAN CENTER Edison, NJ 08837 |
| Contact | Catherina Madormo |
| Correspondent | Catherina Madormo HOSPAL MEDICAL CORP. 21 NORTHFIELD AVE. RARITAN CENTER Edison, NJ 08837 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-14 |
| Decision Date | 1987-12-29 |