The following data is part of a premarket notification filed by Toray Industries (america), Inc. with the FDA for Toray Filtryzer Bk Series.
| Device ID | K883407 |
| 510k Number | K883407 |
| Device Name: | TORAY FILTRYZER BK SERIES |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | TORAY INDUSTRIES (AMERICA), INC. 280 PARK AVE. New York, NY 10017 |
| Contact | Kohki Ueno |
| Correspondent | Kohki Ueno TORAY INDUSTRIES (AMERICA), INC. 280 PARK AVE. New York, NY 10017 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-11 |
| Decision Date | 1989-02-27 |