FDA 510(k) Application Details - K161905

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K161905
Device Name	Staple, Implantable
Applicant	CHANGZHOU XIN NENG YUAN MEDICAL STAPLER CO.,LTD. NO.51, SHUISHAN RD, ZHONGLOU ECONOMIC DEVELOPMENT ZONE Changzhou 213023 CN Other 510(k) Applications for this Company
Contact	Boping Ma 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	07/11/2016
Decision Date	11/17/2016
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