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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 K123527
Device Name AIRLIFE
Applicant
CAREFUSION
1500 WAUKEGAN ROAD
WAUKEGAN,  IL  60060
Applicant Contact ERIKA FERNANDEZ
Correspondent
CAREFUSION
1500 WAUKEGAN ROAD
WAUKEGAN,  IL  60060
Correspondent Contact ERIKA FERNANDEZ
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/16/2012
Decision Date 04/25/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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