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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 K041418
Device Name AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER
Applicant
Cardinal Health
1500 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Applicant Contact LAVENIA FORD
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Correspondent Contact NED DEVINE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/27/2004
Decision Date 06/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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