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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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 Number882.5275
Classification Product Code
JXI  
Date Received10/08/2015
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
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