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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 K190649
Device Name FUJIFILM Endoscope Model EC-760S-V/L
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 Liza Dejesa-Jamanila
Regulation Number876.1500
Classification Product Code
FDF  
Date Received03/13/2019
Decision Date 05/07/2019
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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