FDA 510(k) Application Details - K230617

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K230617
Device Name	Mask, Surgical
Applicant	Henan Chaoya Medical Equipment Co., Ltd. No. 19, 13th Street, Economic and Technological Development Zhengzhou CN Other 510(k) Applications for this Company
Contact	Ruihua Miao 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	03/06/2023
Decision Date	06/01/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review