FDA 510(k) Application Details - K030564

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K030564
Device Name	Electrode, Cutaneous
Applicant	UNITED PACIFIC, INC. 400 NORTHEAST DR., UNIT F 20/21 BUSINESS CENTER, UNIT F COLUMBIA, SC 29203 US Other 510(k) Applications for this Company
Contact	KEVIN OUTRED Other 510(k) Applications for this Contact
Regulation Number	882.1320   More FDA Info for this Regulation Number
Classification Product Code	GXY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/21/2003
Decision Date	09/12/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review