FDA 510(k) Application Details - K143129

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K143129
Device Name	Staple, Implantable
Applicant	EziSurg Medical Co.,Ltd. Room 312, Bldg 2, No.1690 Cailun Road Zhangjiang High-Tech Park,Pudong Shanghai 201203 CN Other 510(k) Applications for this Company
Contact	Johnny Yan Other 510(k) Applications for this Contact
Regulation Number	878.4750   More FDA Info for this Regulation Number
Classification Product Code	GDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2014
Decision Date	01/29/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review