FDA 510(k) Application Details - K131954

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K131954
Device Name	Needle, Hypodermic, Single Lumen
Applicant	SHANGHAI CARELIFE INTERNATIONAL TRADING CO., LTD. ROOM 1707, YINQIAO BLDG, NO 58 JINXIN ROAD SHANGHAI, PUDONG 201206 CN Other 510(k) Applications for this Company
Contact	WILLIAM CONETY Other 510(k) Applications for this Contact
Regulation Number	880.5570   More FDA Info for this Regulation Number
Classification Product Code	FMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2013
Decision Date	05/29/2014
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