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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 K162242
Device Name Comfort Flo Humidification System
Applicant
TELEFLEX MEDICAL, INC
2917 WECK DRIVE
RESEARCH TRIANGLE PARK,  NC  27709
Applicant Contact BRIAN GALL
Correspondent
TELEFLEX MEDICAL, INC
2917 WECK DRIVE
RESEARCH TRIANGLE PARK,  NC  27709
Correspondent Contact BRIAN GALL
Regulation Number868.5450
Classification Product Code
BTT  
Date Received08/10/2016
Decision Date 01/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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