FDA 510(k) Application Details - K162566

Device Classification Name	Needle, Acupuncture, Single Use   More FDA Info for this Device
510(K) Number	K162566
Device Name	Needle, Acupuncture, Single Use
Applicant	CHANGCHUN AIK MEDICAL DEVICES CO., LTD NO. 25, KAREN INDUSTRIAL PARK, JIUTAI ECONOMIC DEVELOPMENT ZONE CHANGCHUN 130507 CN Other 510(k) Applications for this Company
Contact	XINGWANG LI 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	09/14/2016
Decision Date	05/11/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review