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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 K221452
Device Name DiLumen C1, EZ1 and Tool Mount
Applicant
Lumendi, LLC
253 Post Road West
Westport,  CT  06880
Applicant Contact Dennis Daniels
Correspondent
Hogan Lovells U.S. LLP
555 13th Street NW
Washington,  DC  20004
Correspondent Contact John J Smith
Regulation Number876.1500
Classification Product Code
FDF  
Date Received05/18/2022
Decision Date 02/10/2023
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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