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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 K153748
Device Name AirLife Misty Finity Nebulizer
Applicant
Care Fusion
75 N Fairway Dr.
Vernon Hills,  IL  60047
Applicant Contact Erika Fernandez
Correspondent
Vyaire Medical
26125 Riverwoods Blvd.
Mettawa,  IL  60045
Correspondent Contact Colleen O'Keeffe
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/29/2015
Decision Date 05/17/2017
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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