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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K202134
Device Name Well Lead All Silicone Foley Catheter with Temperature Sensor
Applicant
Well Lead Medical Co., LTD.
C-4# Jinhu Industrial Estate, Hualong, Panyu
Guangzhou,  CN 511434
Applicant Contact Jenny Zhu
Correspondent
Well Lead Medical Co., LTD.
C-4# Jinhu Industrial Estate, Hualong, Panyu
Guangzhou,  CN 511434
Correspondent Contact Jenny Zhu
Regulation Number876.5130
Classification Product Code
EZL  
Date Received07/31/2020
Decision Date 04/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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