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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 K090915
Device Name STERILE WATER FOR INHALATION FLEX BAG, USP
Applicant
CARDINAL HEALTH, INC.
1430 WAUKEGAN ROAD- MPKB-2B
MCGAW PARK,  IL  60085
Applicant Contact KIMBERLY SOUTHWELL
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DIVINE
Regulation Number868.5450
Classification Product Code
BTT  
Date Received04/01/2009
Decision Date 11/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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