FDA 510(k) Application Details - K163161

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K163161
Device Name	Syringe, Piston
Applicant	JiangXi HongDa Medical Equipment Group Ltd. No. 39 South Shengli Road, Jinxian County Nanchang 331700 CN Other 510(k) Applications for this Company
Contact	Yang Xiaohua 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	11/10/2016
Decision Date	03/20/2017
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