FDA 510(k) Application Details - K221682

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K221682
Device Name	Mask, Surgical
Applicant	JSN Holdings, LLC 1735 Dilworth Road East Matthews, NC 28203 US Other 510(k) Applications for this Company
Contact	Brian Tedesco 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	06/10/2022
Decision Date	01/13/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review