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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 K120939
Device Name AERONEB PRO
Original Applicant
AEROGEN LTD
galway business park, dangan
galway,  IE galway
Original Contact martha folan
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/29/2012
Decision Date 04/26/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
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