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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K150173
Device Name Aerobika OPEP Devive with Manometer
Applicant
Trudell Medical International
725 Third Street
London,Ontario,  CA n5V 5G4
Applicant Contact Darryl Fischer
Correspondent
Trudell Medical International
725 Third Street
London,Ontario,  CA n5V 5G4
Correspondent Contact Darryl Fischer
Regulation Number868.5690
Classification Product Code
BWF  
Date Received01/26/2015
Decision Date 10/15/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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