The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Filtral Tm 20 Hemodialyzer/filter.
| Device ID | K893742 |
| 510k Number | K893742 |
| Device Name: | FILTRAL TM 20 HEMODIALYZER/FILTER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | HOSPAL MEDICAL CORP. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg, VA 23185 |
| Contact | Jo Lang |
| Correspondent | Jo Lang HOSPAL MEDICAL CORP. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg, VA 23185 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-17 |
| Decision Date | 1989-07-24 |