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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holding Chambers, Direct Patient Interface
510(k) Number K242667
Device Name AeroChamber2go Anti-Static Valved Holding Chamber
Applicant
Trudell Medical International
725 Baransway Dr.
London,  CA N5V 5G4
Applicant Contact Marianne Tanton
Correspondent
Trudell Medical International
725 Baransway Dr.
London,  CA N5V 5G4
Correspondent Contact Marianne Tanton
Regulation Number868.5630
Classification Product Code
NVP  
Date Received09/05/2024
Decision Date 01/15/2025
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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