FDA 510(k) Application Details - K150729

Device Classification Name	N95 Respirator With Antimicrobial/Antiviral Agent   More FDA Info for this Device
510(K) Number	K150729
Device Name	N95 Respirator With Antimicrobial/Antiviral Agent
Applicant	Nexera Medical Inc. 3343 West Commercial Blvd, Suite 103 Ft.Lauderdale, FL 33309 US Other 510(k) Applications for this Company
Contact	Paul Sallarulo 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	03/20/2015
Decision Date	12/29/2015
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