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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 K152257
Device Name Fujifilm Duodenoscope Model ED-530XT
Applicant
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
10 HIGH POINT DRIVE
WAYNE,  NJ  07470
Applicant Contact AARON GE
Correspondent
HOGAN LOVELLS US LLP
555 THIRTEENTH STREET NW
WASHINGTON,  DC  20004
Correspondent Contact JOHN J SMITH
Regulation Number876.1500
Classification Product Code
FDT  
Date Received08/10/2015
Decision Date 07/21/2017
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
Recalls CDRH Recalls
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