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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gastrointesinal lesion software detection system
510(k) Number K211326
Device Name EndoScreener
Chengdu Wision Medical Device Co., LTD.
Unit 802, Floor 8, Building 17, Yintaicheng, No. 1999 Yizhou
Road, Wuhou District
Chengdu,  CN 610041
Applicant Contact JingJia Liu
Hogan Lovells US LLP
555 Thirteenth St, NW
Washington,  DC  20004
Correspondent Contact John J Smith
Regulation Number876.1520
Classification Product Code
Date Received04/30/2021
Decision Date 11/19/2021
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