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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K210618
Device Name Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series
Applicant
Chongqing Jinshan Science & Technology Co., Ltd.
Yubei District #18 Ningshang Ave.
Jinshan International Industrial City
Chongqing,  CN 400000
Applicant Contact Qing Xu
Correspondent
Chongqing Jinshan Science & Technology Co., Ltd.
Yubei District #18 Ningshang Ave.
Jinshan International Industrial City
Chongqing,  CN 400000
Correspondent Contact Qing Xu
Regulation Number876.1500
Classification Product Code
OCX  
Date Received03/01/2021
Decision Date 10/20/2021
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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