FDA 510(k) Application Details - K172500

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K172500
Device Name	Mask, Surgical
Applicant	YTS GLOBAL INC. 7406 ALBAN STATION CT STE A 108 SPRINGFIELD, VA 22150 US Other 510(k) Applications for this Company
Contact	Eddie Nguyen 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	08/18/2017
Decision Date	03/01/2018
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