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FDA 510(k) Application Details - DEN170092
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN170092
Device Name
Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System
Applicant
Fluoptics
7 Parvis Louis Neel
CS 20050
Grenoble Cedex 9 38040 FR
Other 510(k) Applications for this Company
Contact
Odelie Allard
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QDG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/22/2017
Decision Date
11/02/2018
Decision
DENG -
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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