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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
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
10 high point drive
wayne,  NJ  07470
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1394 25th street, nw
buffalo,  MN  55313
Correspondent Contact mark job
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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