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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 K160015
Device Name Pure Vu
Applicant
Motus GI Medical Technologies Ltd.
22 Keren Ha'yesod St.
Tirat Carmel,  IL 3902638
Applicant Contact Hagit Ephrath
Correspondent
Hogan Lovells US LLP
Columbia Square, 555 13th Street, NW
Washington,  DC  20004
Correspondent Contact Jonathan Kahan
Regulation Number876.1500
Classification Product Code
FDF  
Date Received01/04/2016
Decision Date 09/22/2016
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
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