FDA 510(k) Application Details - K130230

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K130230
Device Name	Syringe, Piston
Applicant	WUXI YUSHOU MEDICAL APPLICANCES CO., LTD 215# XIGANG ROAD DONGBEITANG WUXI CITY, JIANGSU 214191 CN Other 510(k) Applications for this Company
Contact	GARFIELD WANG Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/29/2013
Decision Date	11/20/2013
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