FDA 510(k) Application Details - K222403

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K222403
Device Name	Gown, Surgical
Applicant	Guangzhou Fuzelong Hygiene Material Co., Ltd 12, Guancun Road, Jiangpu Street, Conghua Guangzhou 510900 CN Other 510(k) Applications for this Company
Contact	Yuehua Zhou Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FYA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2022
Decision Date	01/26/2023
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