FDA 510(k) Application Details - K092828

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K092828
Device Name	Electrode, Cutaneous
Applicant	HYDRODOT, INC 238 LITTLETON ROAD SUITE 202 WESTFORD, MA 01886 US Other 510(k) Applications for this Company
Contact	KATHLEEN PRINCIPE 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	09/14/2009
Decision Date	01/29/2010
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