FDA 510(k) Application Details - K004008

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K004008
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	HERBO MEDEX INTERNATIONAL, INC. 1151 HOPE ST. STAMFORD, CT 06907 US Other 510(k) Applications for this Company
Contact	RICHARD KEEN Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	GZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2000
Decision Date	12/13/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review