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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Nephrostomy
510(k) Number K250448
Device Name Disposable Percutaneous Nephrostomy Dilatation Kit
Applicant
Shenzhen Trious Medical Technology Co., Ltd.
Rm.102-2, Longtian Tongfuyu Ind Estate #11-3, And Rm.401 &
402, Bldg. D3, Yingzhan S&T Estate, Longtian Tongfuyu Rd. #8
Shenzhen,  CN
Applicant Contact Yi Yingfang
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Rm. 1308, Baohua International Plaza, W. Guangzhong
Rd. 555, Jingan District
Shanghai,  CN
Correspondent Contact Kang Kyra
Classification Product Code
LJE  
Date Received02/18/2025
Decision Date 07/03/2025
Decision Substantially Equivalent (SESE)
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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