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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 K120446
Device Name FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
Original Applicant
FUJINON, INC.
10 high point dr.
wayne,  NJ  07470
Original Contact mark job
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
ITX  
Date Received02/14/2012
Decision Date 08/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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