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 |