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 |