FDA 510(k) Application Details - K221753

Device Classification Name	More FDA Info for this Device
510(K) Number	K221753
Device Name	Kangbeier Child Surgical Mask
Applicant	Xinxiang Kangbeier Medical Technology Co., Ltd. East Mancun Industrial District Changyuan 453400 CN Other 510(k) Applications for this Company
Contact	Shaoju Tian Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/2022
Decision Date	12/21/2023
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