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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastroscope And Accessories, Flexible/Rigid
510(k) Number K181763
Device Name FUJIFILM Ultrasonic Endoscope
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
FDS  
Subsequent Product Code
ITX  
Date Received07/03/2018
Decision Date 07/27/2018
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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