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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Channel Accessory
510(k) Number K220884
Device Name Disposable Endoscope Valve Sets
Applicant
Sml Med-Tech Solutions Limited
Rm.406, Wah Yiu Indl Ctr, 30-32 Au Pui Wan St.
Fo Tan, N.T.,  CN
Applicant Contact Mark Ko
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plz., Shuixi Rd.,
Huangpu District
Guangzhou,  CN
Correspondent Contact Cassie Lee
Regulation Number876.1500
Classification Product Code
ODC  
Date Received03/28/2022
Decision Date 01/17/2023
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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