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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 K133360
Device Name AERONEB SOLO; AERONEB SOLO ADAPTER
Applicant
Aerogen, Ltd.
Ida Business Park, Dangan
Galway,  IE GALWAY
Applicant Contact MARTIN CREHAN
Correspondent
Aerogen, Ltd.
Ida Business Park, Dangan
Galway,  IE GALWAY
Correspondent Contact MARTIN CREHAN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/01/2013
Decision Date 10/17/2014
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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