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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 K123614
Device Name SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)
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 Received11/23/2012
Decision Date 03/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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