FDA 510(k) Application Details - K201380

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K201380
Device Name	Mask, Surgical
Applicant	Andon Health Co., Ltd. No. 3 Jin Ping Street,Ya An Road, Nankai District Tianjin 300190 CN Other 510(k) Applications for this Company
Contact	Liu Yi 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	05/26/2020
Decision Date	10/07/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review