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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscopic video imaging system/component, gastroenterology-urology
510(k) Number K150221
Device Name EPX-4440HD and EPX-4400HD with FICE
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
FET  
Subsequent Product Code
GCT  
Date Received01/30/2015
Decision Date 10/01/2015
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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