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FDA 510(k) Application Details - K192286
Device Classification Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
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510(K) Number
K192286
Device Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant
FUJIFILM Corporation
798 Miyanodai Kaisei-Machi
Ashigarakami-Gun 258-8538 JP
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Contact
Randy Vader
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Regulation Number
876.1500
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Classification Product Code
FET
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More FDA Info for this Product Code
Date Received
08/22/2019
Decision Date
05/01/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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