FDA 510(k) Application Details - K201754

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K201754
Device Name	Mask, Surgical
Applicant	Jiangsu JianYu Health Medical Co., Ltd. No. 88 Longxi Avenue, Zhulin Town, Jintan District Changzhou 213241 CN Other 510(k) Applications for this Company
Contact	Andy Shu 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	06/29/2020
Decision Date	12/30/2020
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