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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 K210162
Device Name Endoscope Model EI-740D/S
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
FDS  
Subsequent Product Code
FAM  
Date Received01/21/2021
Decision Date 04/09/2021
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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