FDA 510(k) Application Details - K091410

Device Classification Name	Electrode, Needle, Diagnostic Electromyograph   More FDA Info for this Device
510(K) Number	K091410
Device Name	Electrode, Needle, Diagnostic Electromyograph
Applicant	SPES MEDICA S.R.L. VIA EUROPA-ZONA INDUSTRIALE BATTIPAGLIA 84091 IT Other 510(k) Applications for this Company
Contact	ALFREDO SPADAVECCHIA Other 510(k) Applications for this Contact
Regulation Number	890.1385   More FDA Info for this Regulation Number
Classification Product Code	IKT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2009
Decision Date	08/11/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review