FDA 510(k) Application Details - K131511

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K131511
Device Name	Staple, Implantable
Applicant	CHANGZHOU SINOLINKS MEDICAL INNOVATION CO., LTD P.O. BOX 120-119 SHANGHAI 200120 CN Other 510(k) Applications for this Company
Contact	Diana Hong 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	05/28/2013
Decision Date	07/05/2013
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