FDA 510(k) Application Details - K091055

Device Classification Name	Electrode, Needle, Diagnostic Electromyograph   More FDA Info for this Device
510(K) Number	K091055
Device Name	Electrode, Needle, Diagnostic Electromyograph
Applicant	RHYTHMLINK INTERNATIONAL, LLC 1256 FIRST ST. SOUTH EXTENSION COLUMBIA, SC 29209 US Other 510(k) Applications for this Company
Contact	JAMES M MEWBORNE 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	04/13/2009
Decision Date	06/23/2009
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