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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K991484
Device Name AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006
Applicant
Allegiance Healthcare Corp.
1500 Waukegan Rd.- K
Mcgraw Park,  IL  60085
Applicant Contact SHARON ROBBINS
Correspondent
Allegiance Healthcare Corp.
1500 Waukegan Rd.- K
Mcgraw Park,  IL  60085
Correspondent Contact SHARON ROBBINS
Regulation Number868.5450
Classification Product Code
BTT  
Date Received04/28/1999
Decision Date 05/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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