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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urethral
510(k) Number K241734
Device Name Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
Applicant
Well Lead Medical Co., Ltd.
No.47, Guomao Avenue South, Hualong, Panyu
Guangzhou,  CN 511434
Applicant Contact Jenny Zhu
Correspondent
Well Lead Medical Co., Ltd.
No.47, Guomao Avenue South, Hualong, Panyu
Guangzhou,  CN 511434
Correspondent Contact Jimmy Chen
Regulation Number876.5130
Classification Product Code
GBM  
Date Received06/17/2024
Decision Date 03/05/2025
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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