FDA 510(k) Application Details - K163457

Device Classification Name	Cuff, Nerve   More FDA Info for this Device
510(K) Number	K163457
Device Name	Cuff, Nerve
Applicant	Integra LifeSciences Corporation 311 Enterprise Drive PLAINSBORO, NJ 08536 US Other 510(k) Applications for this Company
Contact	Gabriella Green 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	12/09/2016
Decision Date	01/06/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review