FDA 510(k) Application Details - K090414

Device Classification Name	N95 Respirator With Antimicrobial/Antiviral Agent   More FDA Info for this Device
510(K) Number	K090414
Device Name	N95 Respirator With Antimicrobial/Antiviral Agent
Applicant	NEXERA MEDICAL, INC 1556 EAST COMMERCIAL BLVD. OAKLAND PARK, FL 33334-5752 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	02/18/2009
Decision Date	02/24/2011
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