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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 K173317
Device Name DiLumen C2; DiLumen Tool Mount
Lumendi, LLC
253 Post Road West
Westport,  CT  06880
Applicant Contact Dennis Daniels
Hogan Lovells U.S. LLP
553 13th Street NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number876.1500
Classification Product Code
Date Received10/19/2017
Decision Date 04/17/2018
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