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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 K181437
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
Motus GI Medical Technologies Ltd.
22 Keren Ha'yesod St.
Tirat Carmel,  IL 3902638
Correspondent Contact Hagit Ephrath
Regulation Number876.1500
Classification Product Code
FDF  
Date Received06/01/2018
Decision Date 06/21/2018
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
Predetermined Change
Control Plan Authorized		 No
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