The following data is part of a premarket notification filed by Toray Industries (america), Inc. with the FDA for Toraysulfone Dialyzer.
| Device ID | K002512 |
| 510k Number | K002512 |
| Device Name: | TORAYSULFONE DIALYZER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | TORAY INDUSTRIES (AMERICA), INC. 540 COLLEGE ST. Bellaire, TX 77401 -5010 |
| Contact | Lisa S Jones |
| Correspondent | Lisa S Jones TORAY INDUSTRIES (AMERICA), INC. 540 COLLEGE ST. Bellaire, TX 77401 -5010 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-15 |
| Decision Date | 2001-10-15 |