FDA 510(k) Application Details - K142438

Device Classification Name	More FDA Info for this Device
510(K) Number	K142438
Device Name	Nerve Monitoring Cable System
Applicant	Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.) 375 River Park Circle Marquette, MI 49855 US Other 510(k) Applications for this Company
Contact	Sarah McIntyre Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/29/2014
Decision Date	03/05/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review