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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 K141353
Device Name HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR
Applicant
TELEFLEX MEDICAL , INC.
2917 WEEK DRIVE
RESEARCH TRIANGLE PARK,  NC  27709
Applicant Contact JAMES A COCHIE
Correspondent
TELEFLEX MEDICAL , INC.
2917 WEEK DRIVE
RESEARCH TRIANGLE PARK,  NC  27709
Correspondent Contact JAMES A COCHIE
Regulation Number868.5450
Classification Product Code
BTT  
Date Received05/23/2014
Decision Date 08/01/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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