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