FDA 510(k) Application Details - K172538

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K172538
Device Name	Staple, Implantable
Applicant	Changzhou Kangdi Medical Stapler Co.,Ltd. No.16 Kunlun Road, XinBei Zone Changzhou City 213022 CN Other 510(k) Applications for this Company
Contact	Eve Zhou 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	08/22/2017
Decision Date	11/30/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review