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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 K240167
Device Name Single-use Ureteral Access Sheath
Applicant
Hunan Vathin Medical Instrument Co., Ltd.
1/F, Bldg. 12, Innovation Entrepreneurship Service Center
#9 Chuanqi W. Rd., Jiuhua Economic Development Zone
Xingtan,  CN 411100
Applicant Contact Jing Du
Correspondent
Hunan Vathin Medical Instrument Co., Ltd.
1/F, Bldg. 12, Innovation Entrepreneurship Service Center
#9 Chuanqi W. Rd., Jiuhua Economic Development Zone
Xingtan,  CN 411100
Correspondent Contact Jing Du
Regulation Number876.1500
Classification Product Code
FED  
Date Received01/22/2024
Decision Date 10/08/2024
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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