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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.
PO 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
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