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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 K183607
Device Name FUJIFILM Bronchoscope
Applicant
FUJIFILM Corporation
798 Miyanodai Kaisei-Machi
Ashigarakami-Gun,  JP 258-8538
Applicant Contact Randy Vader
Correspondent
FUJIFILM Medical Systems U.S.A., Inc.
81 Hartwell Avenue
Lexington,  MA  02421
Correspondent Contact Jeffrey Wan
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received12/26/2018
Decision Date 08/23/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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