FILTRYZER
Dialyzer, High Permeability With Or Without Sealed Dialysate System
TORAY INDUSTRIES (AMERICA), INC.
The following data is part of a premarket notification filed by Toray Industries (america), Inc. with the FDA for Filtryzer.
Pre-market Notification Details
| Device ID | K942681 |
| 510k Number | K942681 |
| Device Name: | FILTRYZER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| 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 | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-07 |
| Decision Date | 1995-06-22 |
Trademark Results [FILTRYZER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FILTRYZER 73427316 1283245 Live/Registered |
Toray Kabushiki Kaisha 1983-05-24 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.