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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 K131912
Device Name CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN
Applicant
TELEFLEX, INC.
2917 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Applicant Contact Amanda Webb
Correspondent
TELEFLEX, INC.
2917 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Correspondent Contact Amanda Webb
Regulation Number868.5450
Classification Product Code
BTT  
Date Received06/26/2013
Decision Date 03/06/2014
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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