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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 K181649
Device Name AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)
Applicant
Trudell Medical International
725 Third Street
London,  CA N5V 5G4
Applicant Contact Marianne Tanton
Correspondent
Trudell Medical International
725 Third Street
London,  CA N5V 5G4
Correspondent Contact Marianne Tanton
Regulation Number868.5630
Classification Product Code
NVP  
Date Received06/22/2018
Decision Date 01/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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