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FDA 510(k) Application Details - K152967
Device Classification Name
Cuff, Nerve
More FDA Info for this Device
510(K) Number
K152967
Device Name
Cuff, Nerve
Applicant
TOYOBO CO., LTD.
2-8 DOJIMA HAMA 2- CHOME
KITA-KU 530-8230 JP
Other 510(k) Applications for this Company
Contact
YUTA KAWAKATSU
Other 510(k) Applications for this Contact
Regulation Number
882.5275
More FDA Info for this Regulation Number
Classification Product Code
JXI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/08/2015
Decision Date
06/22/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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