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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 K190274
Device Name Endotracheal Tube
Applicant
Tianjin Medis Medical Device Co., Ltd.
No. 15-A, Saida One Avenue, Xiqing Economic Development Area
Tainjin,  CN 300385
Applicant Contact Yongzhi Wu
Correspondent
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number868.5730
Classification Product Code
BTR  
Date Received02/08/2019
Decision Date 07/30/2019
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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