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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 K190213
Device Name Yikang Endotracheal Tube
Applicant
Jiangxi Yikang Medical Instrument Group Co., Ltd.
188 Aihua Rd., Jinxian County
Nanchang,  CN 331725
Applicant Contact Nicholas Su
Correspondent
Jiangxi Yikang Medical Instrument Group Co., Ltd.
188 Aihua Rd., Jinxian County
Nanchang,  CN 331725
Correspondent Contact Nicholas Su
Regulation Number868.5730
Classification Product Code
BTR  
Date Received02/04/2019
Decision Date 09/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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