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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 K053605
Device Name AEROECLIPSE II BREATH ACTUATED NEBULIZER
Applicant
Trudell Medical Intl.
725 Third St.
London,  CA N5V 5G4
Applicant Contact JOHN STRAATMAN
Correspondent
Trudell Medical Intl.
725 Third St.
London,  CA N5V 5G4
Correspondent Contact JOHN STRAATMAN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/27/2005
Decision Date 02/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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