FDA 510(k) Application Details - K211275

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K211275
Device Name	Mask, Surgical
Applicant	PremiumEStore, LLC 2601 Reliance Drive, Suite 102 Virginia Beach, VA 23452 US Other 510(k) Applications for this Company
Contact	Brent Dillie 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	04/27/2021
Decision Date	05/25/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review