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510(k) K090915

STERILE WATER FOR INHALATION FLEX BAG, USP by Cardinal Health, Inc. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2009
Date Received
April 1, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

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