FDA 510(k) Application Details - K964051

Device Classification Name	Needle, Acupuncture, Single Use   More FDA Info for this Device
510(K) Number	K964051
Device Name	Needle, Acupuncture, Single Use
Applicant	S-TCM ENTERPRISES, INC. 13010 RESEARCH BLVD., SUITE 103 AUSTIN, TX 78750 US Other 510(k) Applications for this Company
Contact	GUOJI GONG, M.D. Other 510(k) Applications for this Contact
Regulation Number	880.5580   More FDA Info for this Regulation Number
Classification Product Code	MQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/1996
Decision Date	11/05/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review