FDA 510(k) Application Details - K983097

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K983097
Device Name	Electrode, Cutaneous
Applicant	UNI-PATCH, INC. P.O. BOX 271 1313 WEST GRANT BLVD. WABASHA, MN 55981-0271 US Other 510(k) Applications for this Company
Contact	MANAGER J GEOLAT 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	08/24/1998
Decision Date	09/17/1999
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