The following data is part of a premarket notification filed by Toyobo Co., Ltd. with the FDA for Nerbridge.
| Device ID | K152967 |
| 510k Number | K152967 |
| Device Name: | NERBRIDGE |
| Classification | Cuff, Nerve |
| Applicant | TOYOBO CO., LTD. 2-8 DOJIMA HAMA 2- CHOME Kita-ku, JP 530-8230 |
| Contact | Yuta Kawakatsu |
| Correspondent | James A. Boiani, Ms, Jd Epstein Becker & Green, P.C. 1227 25th St. NW Ste. 700 Washington, DC 20037 |
| Product Code | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-08 |
| Decision Date | 2016-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04965838907456 | K152967 | 000 |
| 04965838907449 | K152967 | 000 |
| 04965838907425 | K152967 | 000 |
| 04965838907418 | K152967 | 000 |
| 04965838907395 | K152967 | 000 |
| 04965838907463 | K152967 | 000 |
| 04965838907401 | K152967 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NERBRIDGE 86415615 4865481 Live/Registered |
Toyobo Co., Ltd. 2014-10-06 |