FDA 510(k) Application Details - K973444

Device Classification Name	Electrode, Needle, Diagnostic Electromyograph   More FDA Info for this Device
510(K) Number	K973444
Device Name	Electrode, Needle, Diagnostic Electromyograph
Applicant	MEDELEC, INC. D.B.A. TECA CORP. 3 CAMPUS DR. PLEASANTVILLE, NY 10570 US Other 510(k) Applications for this Company
Contact	JAMES P HURLMAN 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	09/11/1997
Decision Date	11/20/1997
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