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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
510(k) Number K083176
Device Name PASTURE, MODELS: F550, A520
Applicant
Pasture Pharma Pte, Ltd.
29266 Via Frontera
Murrieta,  CA  92563
Applicant Contact SARAH HASSAN
Correspondent
Pasture Pharma Pte, Ltd.
29266 Via Frontera
Murrieta,  CA  92563
Correspondent Contact SARAH HASSAN
Regulation Number880.6260
Classification Product Code
NZJ  
Date Received10/28/2008
Decision Date 01/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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