FDA 510(k) Application Details - K093189

Device Classification Name	Respirator, N95, For Use By The General Public In Public Health Medical Emergencies   More FDA Info for this Device
510(K) Number	K093189
Device Name	Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
Applicant	GLAXOSMITHKLINE CONSUMER HEALTHCARE 1500 LITTLETON RD. PARSIPPANY, NJ 07054-3884 US Other 510(k) Applications for this Company
Contact	ZINATARA MANJI Other 510(k) Applications for this Contact
Regulation Number	880.6260   More FDA Info for this Regulation Number
Classification Product Code	NZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2009
Decision Date	07/02/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review