The following data is part of a premarket notification filed by Toray Industries (america), Inc. with the FDA for Filtryzer(tm).
| Device ID | K935471 |
| 510k Number | K935471 |
| Device Name: | FILTRYZER(TM) |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | TORAY INDUSTRIES (AMERICA), INC. 1-1-1 SONOYAMA Otsu-shi, Shiga-ken 520, JP 520 |
| Contact | Lisa S Jones |
| Correspondent | Lisa S Jones TORAY INDUSTRIES (AMERICA), INC. 1-1-1 SONOYAMA Otsu-shi, Shiga-ken 520, JP 520 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-15 |
| Decision Date | 1995-05-19 |