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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K241181
Device Name Disposable Ureteral Guide Sheath
Applicant
Dongguan Zsr Biomedical Technology Company Limited
Unit 448, Qingfeng Rd., Taihu Village, Sanzhong Village
Committee, Qingxi Town
Dongguan,  CN 523651
Applicant Contact Sharon Wen
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Rm. 1308, Baohua International Plaza
West Guangzhong Rd. 555, Jingan District
Shanghai,  CN 200072
Correspondent Contact Kyra Kang
Regulation Number876.1500
Classification Product Code
FED  
Date Received04/29/2024
Decision Date 08/02/2024
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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