FDA 510(k) Application Details - K242679

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K242679
Device Name	Staple, Implantable
Applicant	Fengh Medical Co., Ltd. D3 No. 6 Dongsheng West Road Jiangyin National High-tech Zone Wuxi 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	09/06/2024
Decision Date	10/04/2024
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