FDA 510(k) Application Details - K081923

Device Classification Name	N95 Respirator With Antimicrobial/Antiviral Agent   More FDA Info for this Device
510(K) Number	K081923
Device Name	N95 Respirator With Antimicrobial/Antiviral Agent
Applicant	GLAXOSMITHKLINE CONSUMER HEALTHCARE 1500 LITTLETON RD. PARSIPPANY, NJ 07054-3884 US Other 510(k) Applications for this Company
Contact	ZINATARA A MANJI 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	07/07/2008
Decision Date	07/01/2009
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