FDA 510(k) Application Details - K083758

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K083758
Device Name	Electrode, Cutaneous
Applicant	THE ELECTRODE STORE, INC. 1530 HOLCOMB STREET PORT TOWNSEND, WA 98368 US Other 510(k) Applications for this Company
Contact	CARL YOUNGMANN 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	12/17/2008
Decision Date	08/14/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review