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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bronchoscope (flexible or rigid)
510(k) Number K121035
Device Name FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
Original Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
10 high point drive
wayne,  NJ  07470
Original Contact gina walljasper
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Code
ITX  
Date Received04/05/2012
Decision Date 06/04/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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