FDA 510(k) Application Details - K192105

Device Classification Name	More FDA Info for this Device
510(K) Number	K192105
Device Name	Innonix Antiviral Child's Face Mask
Applicant	Innonix Technologies Limited 13/F LiFung Centre, 2 On Ping Street Siu Lek Yuen,Shatin HK Other 510(k) Applications for this Company
Contact	Tommy Lui Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2019
Decision Date	11/29/2019
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