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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K191220
Device Name Pure Vu System
Applicant
Motus GI Medical Technologies Ltd.
22 Keren Ha'yesod St.
Tirat Carmel,  IL 3902638
Applicant Contact Ravit Peled
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street NW
Washington,  DC  20004
Correspondent Contact Randy Prebula
Regulation Number876.1500
Classification Product Code
FDF  
Date Received05/07/2019
Decision Date 06/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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