FDA 510(k) Application Details - K200576

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K200576
Device Name	Mask, Surgical
Applicant	ClearMask, LLC 900 E. Fayette St., PO Box 22493 Baltimore, MD 21203 US Other 510(k) Applications for this Company
Contact	Aaron Hsu 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	03/05/2020
Decision Date	04/06/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review