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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation
510(k) Number K092484
Device Name HELIOX LOW FLOW SENTRY BLENDER
Applicant
CARDINAL HEALTH 207, INC.
22745 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Applicant Contact MONTHER ABUSHABAN
Correspondent
CARDINAL HEALTH 207, INC.
22745 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Correspondent Contact MONTHER ABUSHABAN
Regulation Number868.5330
Classification Product Code
BZR  
Date Received08/13/2009
Decision Date 04/02/2010
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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