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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 K170234
Device Name Endotracheal tube; Reinforced Endotracheal tube
Applicant
Zhanjiang Star Enterprise Co., Ltd.
#1, W. Jinhua Rd.
Zhanjiang,  TW 524094
Applicant Contact Rongsheng Tang
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
Rm. 1122, #55 Shizhou Middle Rd.
Nanshan District
Shenzhen,  TW GD755
Correspondent Contact Jessie You
Regulation Number868.5730
Classification Product Code
BTR  
Date Received01/25/2017
Decision Date 01/17/2018
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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