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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 K171291
Device Name FUJIFILM Bronchoscope Model EB-530P
Applicant
FUJIFILM Medical Systems U.S.A., Inc.
10 High Point Drive
Wayne,  NJ  07470
Applicant Contact Shraddha S. More
Correspondent
FUJIFILM Medical Systems U.S.A., Inc.
10 High Point Drive
Wayne,  NJ  07470
Correspondent Contact Shraddha S. More
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received05/02/2017
Decision Date 01/19/2018
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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