FDA 510(k) Application Details - K231155

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K231155
Device Name	Mask, Surgical
Applicant	Guangdong Kingfa Sci. & Tech. Co., Ltd. No.28, Delong Ave., Shijiao Town, Qingcheng District Qingyuan 511545 CN Other 510(k) Applications for this Company
Contact	Xiaoge Yu Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FXX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/2023
Decision Date	11/07/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review