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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K202796
Device Name SANSIN Tubing Sets for Hemodialysis
Applicant
Jiangxi Sanxin Medtec Co., Ltd.
# 999, Fushan Rd., Xiaolan Economic Development
Nanchang,  CN 330200
Applicant Contact Shuiqing Sun
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number876.5820
Classification Product Code
FJK  
Date Received09/23/2020
Decision Date 09/06/2021
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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