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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 K180405
Device Name FUJIFILM Endoscope Models EC-600HL and EC-600LS
Applicant
Fujifilm Corporation
798 Miyanodai Kaisei-Machi
Ashigara Kami-Gun,  JP 258-8538
Applicant Contact Randy Vader
Correspondent
Fujifilm Medical Systems U.S.A, Inc.
10 High Point Dr.
Wayne,  NJ  07470
Correspondent Contact Jeffrey Wan
Regulation Number876.1500
Classification Product Code
FDF  
Date Received02/14/2018
Decision Date 03/15/2018
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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