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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 K151084
Device Name Well Lead Ureteral Access Sheath
Applicant
Well Lead Medical Co., Ltd.
C-4 Jinhu Industrial Estate Hualong, Panyu
Guangzhou,  CN 511434
Applicant Contact HUANG KAI GEN
Correspondent
Well Lead Medical Co., Ltd.
C-4 Jinhu Industrial Estate Hualong, Panyu
Guangzhou,  CN 511434
Correspondent Contact HUANG KAI GEN
Regulation Number876.1500
Classification Product Code
FED  
Date Received04/22/2015
Decision Date 01/07/2016
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
Predetermined Change
Control Plan Authorized		 No
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