FDA 510(k) Application Details - K211458

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K211458
Device Name	Staple, Implantable
Applicant	Ningbo VeryKind Medical Device Co., Ltd. #100 Jinghua Road, High-tech Industrial Development Zone Ningbo 315040 CN Other 510(k) Applications for this Company
Contact	Pengfei 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	05/11/2021
Decision Date	12/30/2021
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