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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 K203028
Device Name FUJIFILM Distal End Cap
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 Jeffrey Wan
Regulation Number876.1500
Classification Product Code
FDT  
Date Received10/02/2020
Decision Date 10/30/2020
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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