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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 K001137
Device Name AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)
Applicant
Trudell Medical Int'L
725 Third St.
London,  CA N5V 5G4
Applicant Contact TOM HOLBROOK
Correspondent
Trudell Medical Int'L
725 Third St.
London,  CA N5V 5G4
Correspondent Contact TOM HOLBROOK
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/10/2000
Decision Date 07/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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