FDA 510(k) Application Details - K083176

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	K083176
Device Name	Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
Applicant	PASTURE PHARMA PTE LTD 29266 VIA FRONTERA MURRIETA, CA 92563 US Other 510(k) Applications for this Company
Contact	SARAH HASSAN 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	10/28/2008
Decision Date	01/23/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review