FDA 510(k) Application Details - K122702

Device Classification Name	N95 Respirator With Antimicrobial/Antiviral Agent   More FDA Info for this Device
510(K) Number	K122702
Device Name	N95 Respirator With Antimicrobial/Antiviral Agent
Applicant	FILLIGENT LIMITED 7TH FLLOR, 69 JERVOIS STREET, SHEUNG WAN HONG KONG HK CN Other 510(k) Applications for this Company
Contact	KAI DEUSCH Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	ONT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/04/2012
Decision Date	03/18/2013
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