Cleared Traditional

PASTURE, MODELS: F550, A520

K083176 · Pasture Pharma Pte, Ltd. · General Hospital
Jan 2009
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K083176 is an FDA 510(k) clearance for the PASTURE, MODELS: F550, A520, a Respirator, N95, For Use By The General Public In Public Health Medical Emergencies (Class II — Special Controls, product code NZJ), submitted by Pasture Pharma Pte, Ltd. (Murrieta, US). The FDA issued a Cleared decision on January 23, 2009, 87 days after receiving the submission on October 28, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6260.

Submission Details

510(k) Number K083176 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2008
Decision Date January 23, 2009
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code NZJ — Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6260
Definition It Is Intended To Cover The Nose And Mouth Of The Wearer To Help Reduce Wearer Exposure To Pathogenic Biological Airborne Particulates During Public Health Medical Emergencies, Such As Influenza Pandemic And Also Protects The Wearer From Splash And Spray Of Body Fluids.