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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
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