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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 K232507
Device Name Aerogen®Solo Nebulizer System
Applicant
Aerogen, Ltd.
Galway Business Park
Dangan Galway,  IE
Applicant Contact Thelma Marley
Correspondent
Aerogen Ltd. C/O Promedic, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/18/2023
Decision Date 05/10/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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