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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
510(k) Number K151461
Device Name Hybernite RT
Applicant
Plastiflex Group NV
Beverloosesteenweg 99
Paal-Beringen,  BE 3583
Applicant Contact RAF VAN ROY
Correspondent
Qserve Group, Us, Inc.
P.O. Box 940
Charlestown,  NH  03603
Correspondent Contact Patsy J Trisler
Regulation Number868.5270
Classification Product Code
BZE  
Date Received06/01/2015
Decision Date 03/24/2016
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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