FDA 510(k) Application Details - K212109

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K212109
Device Name	Mask, Surgical
Applicant	SpinTech LLC 1920 Flintstone Drive Statesville, NC 28677 US Other 510(k) Applications for this Company
Contact	Jim Jean 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	07/06/2021
Decision Date	11/14/2021
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