FDA 510(k) Application Details - K964437

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K964437
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	SKYLARK DEVICE CO., LTD. 34 CHUNG SHAN NORTH RD., 12TH FL., SEC. 3 TAIPEI TW Other 510(k) Applications for this Company
Contact	GEORGE K CHEN 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	11/05/1996
Decision Date	08/14/1998
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