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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 K160196
Device Name Fujifilm Video Colonoscope Model EC-600WL V2
Applicant
FUJIFILM Medical Systems U.S.A., Inc.
10 High Point Drive
Wayne,  NJ  07470
Applicant Contact Shraddha More
Correspondent
Hogan Lovells US LLP
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number876.1500
Classification Product Code
FDF  
Date Received01/27/2016
Decision Date 02/23/2016
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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