FDA 510(k) Application Details - K203455

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K203455
Device Name	Mask, Surgical
Applicant	Fujian Kang Chen Daily Necessities CO., LTD No.55 Houdun Road, houmao Industrial Zone, Fengze District Quanzhou 362000 CN Other 510(k) Applications for this Company
Contact	Shuyan Wang 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	11/23/2020
Decision Date	09/13/2021
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