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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 K071958
Device Name THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS
Applicant
Smiths Medical Asd, Inc.
160 Weymouth St.
Rockland,  MA  02370
Applicant Contact CHRISTINE LLOYD
Correspondent
Smiths Medical Asd, Inc.
160 Weymouth St.
Rockland,  MA  02370
Correspondent Contact CHRISTINE LLOYD
Regulation Number868.5450
Classification Product Code
BTT  
Subsequent Product Code
BZE  
Date Received07/16/2007
Decision Date 11/21/2007
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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