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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K161110
Device Name ClearPetra Suction-Evacuation Sheath
Applicant
WELL LEAD MEDICAL CO., LTD.
C-4#Jinhu Industrial Estate, Hualong, Panyu
Guangzhou,  CN 511434
Applicant Contact Han Guang Yuan
Correspondent
WELL LEAD MEDICAL CO., LTD.
C-4#Jinhu Industrial Estate, Hualong, Panyu
Guangzhou,  CN 511434
Correspondent Contact Han Guang Yuan
Regulation Number876.1500
Classification Product Code
FED  
Subsequent Product Codes
FAJ   FGA  
Date Received04/20/2016
Decision Date 10/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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