FDA 510(k) Application Details - K010431

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K010431
Device Name	Electrode, Cutaneous
Applicant	LEAD-LOK, INC. 500 AIRPORT WAY SANDPOINT, ID 83864 US Other 510(k) Applications for this Company
Contact	CHRIS HEALY 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	02/13/2001
Decision Date	09/06/2001
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