FDA 510(k) Application Details - K953361

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K953361
Device Name	Electrode, Cutaneous
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	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	07/17/1995
Decision Date	01/22/1996
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