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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 K061736
Device Name COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA
Applicant
TELEFLEX MEDICAL
2345 WAUKEGAN ROAD
BANNOCKBURN,  IL  60015
Applicant Contact LORI HAYS
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact NEIL E DEVINE
Regulation Number868.5450
Classification Product Code
BTT  
Date Received06/20/2006
Decision Date 08/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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