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FDA 510(k) Application Details - K160196
Device Classification Name
Colonoscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K160196
Device Name
Colonoscope And Accessories, Flexible/Rigid
Applicant
FUJIFILM Medical Systems U.S.A., Inc.
10 High Point Drive
Wayne, NJ 07470 US
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Contact
Shraddha More
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
01/27/2016
Decision Date
02/23/2016
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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