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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 K122535
Device Name FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H
Original Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
10 high point drive
wayne,  NJ  07470
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received08/20/2012
Decision Date 12/13/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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