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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
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