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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 K173392
Device Name Pure-Vu System
Applicant
Motus GI Medical Technologies Ltd.
22 Keren Ha'yesod St.
Tirat Carmel,  IL 3902638
Applicant Contact Hagit Ephrath
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact Hagit Ephrath
Regulation Number876.1500
Classification Product Code
FDF  
Date Received10/30/2017
Decision Date 12/12/2017
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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