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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 K103635
Device Name CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S
Applicant
Aerogen, Ltd.
Galway Business Park, Dangan
Galway,  IE
Applicant Contact MARTHA FOLAN
Correspondent
Aerogen, Ltd.
Galway Business Park, Dangan
Galway,  IE
Correspondent Contact MARTHA FOLAN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/13/2010
Decision Date 05/13/2011
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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