FDA 510(k) Application Details - K162947

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K162947
Device Name	Staple, Implantable
Applicant	CHONGQING QMI SURGICAL CO., LTD A ZONE 1ST FLOOR, YANGLIU ROAD NO.2 NORTH NEW ZONE CHONGQING 401121 CN Other 510(k) Applications for this Company
Contact	KANG LI 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	10/21/2016
Decision Date	03/03/2017
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