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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K050994
Device Name AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
Applicant
Cardinal Health
1430 WAUKEGAN RD.
BUILDING KB
MCGAW PARK,  IL  60085
Applicant Contact SHARON NICHOLS
Correspondent
Cardinal Health
1430 WAUKEGAN RD.
BUILDING KB
MCGAW PARK,  IL  60085
Correspondent Contact SHARON NICHOLS
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/19/2005
Decision Date 08/03/2005
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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