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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
Model AG-AP6000-US
Device Name AERONEB PRO
Original Applicant
AEROGEN LTD
galway business park, dangan
galway,  EI galway
Original Contact martha folan
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/29/2012
Decision Date 04/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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