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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 K142629
Device Name EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
10 HIGH POINT DRIVE
WAYNE,  NJ  07470
Applicant Contact Mary Moore
Correspondent
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
10 HIGH POINT DRIVE
WAYNE,  NJ  07470
Correspondent Contact Mary Moore
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Codes
FAM   FDF  
Date Received09/16/2014
Decision Date 05/14/2015
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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