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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 K140667
Device Name WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
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 Number876.5130
Classification Product Code
EZL  
Date Received03/18/2014
Decision Date 12/15/2014
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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