FDA 510(k) Application Details - K080902

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K080902
Device Name	Electrode, Cutaneous
Applicant	LORENZ BIOTECH S.P.A. 49 PLAIN STREET NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	ROSINA ROBINSON 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	04/02/2008
Decision Date	06/13/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review