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FDA 510(k) Application Details - K153483
Device Classification Name
Colonoscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K153483
Device Name
Colonoscope And Accessories, Flexible/Rigid
Applicant
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
10 HIGH POINT DR
WAYNE, NJ 07470 US
Other 510(k) Applications for this Company
Contact
Aaron Ge
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FDF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/03/2015
Decision Date
12/15/2015
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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