FDA 510(k) Application Details - K121474

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K121474
Device Name	Staple, Implantable
Applicant	CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD. 77325 JOYCE WAY ECHO, OR 97826 US Other 510(k) Applications for this Company
Contact	CHARLES MACK 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	05/18/2012
Decision Date	07/16/2012
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