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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 (w/wo connector)
510(k) Number K160694
Device Name Disposable Endotracheal tube, sterile, AccuCuff
Applicant
TIANJIN MEDIS MEDICAL DEVICE CO., LTD.
10-A TIANZHI INDUSTRIAL CENTER, NO. 12 HONG YUAN ROAD
TIANJIN CITY,  CN 300385
Applicant Contact ZHENCHUANG YANG
Correspondent
OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD
LEVEL 7, JIN GUI BUSINESS CENTER, 982 CUNYUN ROAD,
BAIYUN DISTRICT
GUANGZHOU,  CN 510420
Correspondent Contact MIKE GU
Regulation Number868.5730
Classification Product Code
BTR  
Subsequent Product Code
BSK  
Date Received03/14/2016
Decision Date 04/07/2017
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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