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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 K192048
Device Name Single Use Endoscope Valves Set
Applicant
Anrei Medical (Hangzhou) Co., Ltd.
#3 Ave.8, Heda
Hangzhou,  CN 310018
Applicant Contact Yang HuiBing
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
R912, B#15, Xiyuehui, #5, Yihe N. Rd., Fangshan
District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number876.1500
Classification Product Code
ODC  
Date Received07/31/2019
Decision Date 05/14/2020
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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