FDA 510(k) Application Details - K152684

Device Classification Name	Cuff, Nerve   More FDA Info for this Device
510(K) Number	K152684
Device Name	Cuff, Nerve
Applicant	POLYGANICS INNOVATIONS BV ROZENBURGLAAN 15A GRONINGEN 9727 DL NL Other 510(k) Applications for this Company
Contact	BETTY IJMKER 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	09/18/2015
Decision Date	01/13/2016
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