FDA 510(k) Application Details - K990100

Device Classification Name	Electrode, Needle   More FDA Info for this Device
510(K) Number	K990100
Device Name	Electrode, Needle
Applicant	TE ME NA S.A.R.L. 390 SCARLET BLVD. OLDSMAR, FL 34677 US Other 510(k) Applications for this Company
Contact	JOE HARMS Other 510(k) Applications for this Contact
Regulation Number	882.1350   More FDA Info for this Regulation Number
Classification Product Code	GXZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/04/1999
Decision Date	08/02/2000
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