FDA 510(k) Application Details - K960591

Device Classification Name	Electrode, Needle, Diagnostic Electromyograph   More FDA Info for this Device
510(K) Number	K960591
Device Name	Electrode, Needle, Diagnostic Electromyograph
Applicant	CHALGREN ENTERPRISES, INC. 8021 CARMEL ST. SUITE B GILROY, CA 95020 US Other 510(k) Applications for this Company
Contact	RICHARD KAISER 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	02/12/1996
Decision Date	06/13/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review