FDA 510(k) Application Details - K212649

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K212649
Device Name	Mask, Surgical
Applicant	Lyncmed Medical Technology (Beijing) Co., Ltd. Room 1601, Building No. 2, Zhubang 2000 Business Building, Balizhuang Xili 99, Chaoyang District Beijing 100022 CN Other 510(k) Applications for this Company
Contact	Naomi Zhou 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	08/23/2021
Decision Date	10/25/2022
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