FDA 510(k) Application Details - K162707

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K162707
Device Name	Staple, Implantable
Applicant	Golden Stapler Surgical Co., Ltd. Building 7A,Jiangsu Wujin Sci-Tech Pioneer Park,256 Mid Mingxin Road Changzhou 213164 CN Other 510(k) Applications for this Company
Contact	Hao Chao 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	09/28/2016
Decision Date	07/14/2017
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