Device Classification Name |
cuff, nerve
|
510(k) Number |
K152967 |
Device Name |
NERBRIDGE |
Applicant |
TOYOBO CO., LTD. |
2-8 DOJIMA HAMA 2- CHOME |
KITA-KU,
JP
530-8230
|
|
Applicant Contact |
YUTA KAWAKATSU |
Correspondent |
Epstein Becker & Green, P.C. |
1227 25th St. NW Ste. 700 |
Washington,
DC
20037
|
|
Correspondent Contact |
James A. Boiani, MS, JD |
Regulation Number | 882.5275
|
Classification Product Code |
|
Date Received | 10/08/2015 |
Decision Date | 06/22/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|