FDA 510(k) Application Details - K011818

Device Classification Name	Electrode, Needle, Diagnostic Electromyograph   More FDA Info for this Device
510(K) Number	K011818
Device Name	Electrode, Needle, Diagnostic Electromyograph
Applicant	NICOLET BIOMEDICAL, INC. 800 LEVANGER LN. STOUGHTON, WI 53589 US Other 510(k) Applications for this Company
Contact	Gary Syring 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	06/11/2001
Decision Date	09/06/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review