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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 K182825
Device Name FUJIFILM Ultrasonic Endoscope
Applicant
FUJIFILM Corporation
798 Miyanodai Kaisei-Machi
Ashigarakami-Gun,  JP 258-8538
Applicant Contact Randy Vader
Correspondent
FUJIFILM Medical Systems U.S.A., Inc.
419 West Ave
Stamford,  CT  06902
Correspondent Contact Jeffrey Wan
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Code
ITX  
Date Received10/04/2018
Decision Date 02/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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