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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K143719
Device Name Aeroneb USB Contoller System
Applicant
Aerogen Limited
Galway Business Park, Dangan
Galway,  IE
Applicant Contact Martin Crehan
Correspondent
Aerogen Limited
Galway Business Park, Dangan
Galway,  IE
Correspondent Contact Martin Crehan
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/29/2014
Decision Date 07/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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