The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Filtral Hemodialyzer.
| Device ID | K852885 |
| 510k Number | K852885 |
| Device Name: | FILTRAL HEMODIALYZER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick, NJ 08816 |
| Contact | Douglas L Vlchek |
| Correspondent | Douglas L Vlchek HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick, NJ 08816 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-09 |
| Decision Date | 1985-09-06 |