FDA 510(k) Application Details - K190246

Device Classification Name	Cuff, Nerve   More FDA Info for this Device
510(K) Number	K190246
Device Name	Cuff, Nerve
Applicant	Monarch Bioimplants GmbH Platz 4 Root 6039 CH Other 510(k) Applications for this Company
Contact	Rivelino Montenegro 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	02/06/2019
Decision Date	05/31/2019
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