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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 K200063
Device Name AeroEclipse* ONE BAN
Applicant
Trudell Medical International
725 Baransway Drive
London,  CA N5V 5G4
Applicant Contact Marianne Tanton
Correspondent
Trudell Medical International
725 Baransway Drive
London,  CA N5V 5G4
Correspondent Contact Marianne Tanton
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/13/2020
Decision Date 07/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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