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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 K112010
Device Name AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)
Applicant
Trudell Medical Intl.
725 Third St.
London,  CA N5V 5G4
Applicant Contact DARRYL FISCHER
Correspondent
Trudell Medical Intl.
725 Third St.
London,  CA N5V 5G4
Correspondent Contact DARRYL FISCHER
Regulation Number868.5630
Classification Product Code
NVP  
Date Received07/14/2011
Decision Date 07/11/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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