FDA 510(k) Application Details - K140340

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K140340
Device Name	Electrode, Cutaneous
Applicant	LEONHARD LANG GMBH P.O. BOX 560 STILLWATER, MN 55082-0560 US Other 510(k) Applications for this Company
Contact	ELAINE DUNCAN Other 510(k) Applications for this Contact
Regulation Number	882.1320   More FDA Info for this Regulation Number
Classification Product Code	GXY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/2014
Decision Date	05/21/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review