FDA 510(k) Application Details - K103061

Device Classification Name	Needle, Acupuncture, Single Use   More FDA Info for this Device
510(K) Number	K103061
Device Name	Needle, Acupuncture, Single Use
Applicant	BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD. NO.45, MINSHENG RD. DANSHUI TOWN TAIPEI COUNTY 251 TW Other 510(k) Applications for this Company
Contact	MICHAEL LEE 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	10/18/2010
Decision Date	06/20/2011
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