FDA 510(k) Application Details - K182476

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K182476
Device Name	Staple, Implantable
Applicant	Fengh Medical Co., Ltd. D3 No.6 Dongsheng West Road, Jiangyin National High-tech Zone Jiangyin 214437 CN Other 510(k) Applications for this Company
Contact	Jiao Liu 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	09/10/2018
Decision Date	12/18/2019
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