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FDA 510(k) Application Details - K180405
Device Classification Name
Colonoscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K180405
Device Name
Colonoscope 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
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Classification Product Code
FDF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/14/2018
Decision Date
03/15/2018
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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