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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 K102240
Device Name NIVO NEBULIZER SYSTEM
Applicant
Aerogen Ireland, Ltd.
M&M Qualtech, Parkmore
Business Park
Galway,  IE
Applicant Contact CAITRIONA CONNEELY
Correspondent
Aerogen Ireland, Ltd.
M&M Qualtech, Parkmore
Business Park
Galway,  IE
Correspondent Contact CAITRIONA CONNEELY
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/09/2010
Decision Date 11/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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