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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
510(k) Number K152251
Device Name Endobronchial Tube
Applicant
Henan Tuoren Medical Device Co., Ltd.
Weiyuan Industrial Zone, Menggang, Changyuan Country
Xinxiang,  CN 453400
Applicant Contact MEIZI ZHANG
Correspondent
Shenzhen Hlongmed Biotech Company
R150-08, E. Bldg., Yihai Plz., Chuangye Rd.,
Nanshan District
Shenzhen,  CN 518054
Correspondent Contact LONG YANG
Regulation Number868.5740
Classification Product Code
CBI  
Date Received08/10/2015
Decision Date 06/10/2016
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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