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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K192286
Device Name FUJIFILM EP-6000 Video Processor
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.
81 Hartwell Ave.
Lexington,  MA  02421
Correspondent Contact Candace Alva
Regulation Number876.1500
Classification Product Code
FET  
Subsequent Product Codes
EOQ   NTN   NWB   PEA  
Date Received08/22/2019
Decision Date 05/01/2020
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
Predetermined Change
Control Plan Authorized		 No
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