FDA 510(k) Application Details - K202831

Device Classification Name	More FDA Info for this Device
510(K) Number	K202831
Device Name	The iMask Child's Face Mask
Applicant	Pac-Dent, Inc. 670 Endeavor Circle Brea, CA 92821 US Other 510(k) Applications for this Company
Contact	Jiahe Li Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2020
Decision Date	08/26/2021
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	N
Expedited Review