FDA 510(k) Application Details - K002411

Device Classification Name	Needle, Acupuncture, Single Use   More FDA Info for this Device
510(K) Number	K002411
Device Name	Needle, Acupuncture, Single Use
Applicant	SHENLING MEDICAL DEVICE CO., LTD 1800 CENTURY PARK EAST SUITE 600 LOS ANGELES, CA 90067-1509 US Other 510(k) Applications for this Company
Contact	GEORGE SU 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	08/07/2000
Decision Date	12/12/2000
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