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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 K183572
Device Name FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/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.
419 West Ave
Stamford,  CT  06902
Correspondent Contact Jeffrey Wan
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
FDF  
Date Received12/21/2018
Decision Date 07/16/2019
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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