FDA 510(k) Application Details - K212366

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K212366
Device Name	Mask, Surgical
Applicant	Heartland Health Products 5389 East Provident Dr Cincinnati, OH 45246 US Other 510(k) Applications for this Company
Contact	Frank Fischer 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	07/30/2021
Decision Date	02/19/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review