FDA 510(k) Application Details - K161757

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K161757
Device Name	Staple, Implantable
Applicant	VICTOR MEDICAL INSTRUMENTS CO.,LTD. NO.21, HUAFENG RD, QISHUYAN DISTRICT Changzhou 213018 CN Other 510(k) Applications for this Company
Contact	Yunhuo Chen 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	06/27/2016
Decision Date	12/05/2016
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