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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 K080926
Device Name AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER
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
CAF  
Date Received04/02/2008
Decision Date 08/12/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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