The following data is part of a premarket notification filed by Toray Industries (america), Inc. with the FDA for Toray Anthron P-u Catheters.
| Device ID | K881236 |
| 510k Number | K881236 |
| Device Name: | TORAY ANTHRON P-U CATHETERS |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| 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 | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-22 |
| Decision Date | 1988-05-11 |