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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Duodenoscope And Accessories, Flexible/Rigid
510(k) Number K191747
FOIA Releasable 510(k) K191747
Device Name FUJIFILM Duodenoscope Model ED-580XT
Applicant
FUJIFILM Corporation
798 Miyanodai Kaisei-Machi
Ashigarakami-Gun,  JP 258-8538
Applicant Contact Randy Vader
Correspondent
FUJIFILM Medical Systems U.S.A., Inc.
81 Hartwell Avenue, Suite 300
Lexington,  MA  02421
Correspondent Contact Kamila Sak
Regulation Number876.1500
Classification Product Code
FDT  
Date Received07/01/2019
Decision Date 09/27/2019
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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