FDA 510(k) Application Details - K203534

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K203534
Device Name	Mask, Surgical
Applicant	Crown Name Disposable Hygiene Products Fty., Ltd. Chengbei Industrial Zone, Zhucheng Ave, Xinzhou District Wuhan 431400 CN Other 510(k) Applications for this Company
Contact	Ying Fang 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	12/02/2020
Decision Date	07/21/2021
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