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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 K182739
Device Name Endotracheal Tube with Evacuation Lumen
Applicant
WELL LEAD MEDICAL CO., LTD.
C-4 # Jinhu Industrial Estate, Hualong, Panyu
Guangzhou,  CN 511434
Applicant Contact Huang Kaigen
Correspondent
WELL LEAD MEDICAL CO., LTD.
No.47, Guomao Avenue South, Hualong, Panyu
Guangzhou,  CN 511434
Correspondent Contact Jenny Zhu
Regulation Number868.5730
Classification Product Code
BTR  
Date Received09/28/2018
Decision Date 12/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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