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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respirator, Surgical
510(k) Number K141876
Device Name Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator
Applicant
Pasture Pharma Pte, Ltd.
38129 Spring Canyon Dr.
Murrieta,  CA  92563
Applicant Contact SARAH HASSAN
Correspondent
Pasture Pharma Pte, Ltd.
38129 Spring Canyon Dr.
Murrieta,  CA  92563
Correspondent Contact SARAH HASSAN
Regulation Number878.4040
Classification Product Code
MSH  
Date Received07/11/2014
Decision Date 10/28/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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