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FDA 510(k) Application Details - K183686
Device Classification Name
Gastroscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K183686
Device Name
Gastroscope And Accessories, Flexible/Rigid
Applicant
Fujifilm Corporation
798 Miyanodai Kaisei-Machi
Ashigarakami-Gun 258-8538 JP
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Contact
Randy Vader
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FDS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/28/2018
Decision Date
02/28/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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