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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 K173825
Device Name MC 300R* Nebulizer
Applicant
Trudell Medical International
725 Third Street
London,  CA n5V 5G4
Applicant Contact Marianne Tanton
Correspondent
Trudell Medical International
725 Third Street
London,  CA n5V 5G4
Correspondent Contact Marianne Tanton
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/18/2017
Decision Date 05/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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