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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K241888
Device Name Single-use Balloon Dilatation Catheter
Applicant
Leo Medical Co., Ltd.
#10 Bldg., 23 Middle Huashan Rd., Xinbei District
Changzhou,  CN 213022
Applicant Contact Guojun Zhang
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119, Shanghai
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number876.5010
Classification Product Code
FGE  
Subsequent Product Code
KNQ  
Date Received06/28/2024
Decision Date 12/20/2024
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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