FDA 510(k) Application Details - K100418

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K100418
Device Name	Electrode, Cutaneous
Applicant	COVIDIEN 15 HAMPSHIRE STREET MANSFIELD, MA 02048 US Other 510(k) Applications for this Company
Contact	WING NG 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	02/16/2010
Decision Date	09/03/2010
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