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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 K153206
Device Name Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
10 HIGH POINT DRIVE
WAYNE,  NJ  07470
Applicant Contact Shraddha More
Correspondent
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
10 HIGH POINT DRIVE
WAYNE,  NJ  07470
Correspondent Contact Shraddha More
Regulation Number876.1500
Classification Product Code
FDS  
Date Received11/05/2015
Decision Date 03/03/2016
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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