FDA 510(k) Application Details - K202595

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K202595
Device Name	Mask, Surgical
Applicant	Premier Guard USA LLC 406 Briarwood Drive Suite 400 Jackson, MS 39206 US Other 510(k) Applications for this Company
Contact	Howard Sherman 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	09/08/2020
Decision Date	01/21/2021
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