FDA 510(k) Application Details - K190891

Device Classification Name	More FDA Info for this Device
510(K) Number	K190891
Device Name	Fluobeam LX
Applicant	Fluoptics 7 Parvis Louis Neel, CS 20050 Grenoble Cedex 9 FR Other 510(k) Applications for this Company
Contact	Odile 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	04/05/2019
Decision Date	07/31/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review