FDA 510(k) Application Details - K162710

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K162710
Device Name	Staple, Implantable
Applicant	TGS Medical Co., Ltd. Building 17, No.8 Jinfeng Road, High-tech Zone Suzhou 214163 CN Other 510(k) Applications for this Company
Contact	Hua Cao 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	02/09/2017
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