FDA 510(k) Application Details - DEN150022

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN150022
Device Name	Ultravision Visual Clearing System
Applicant	Alesi Surgical Ltd. Suite 18, Cardiff Medical Centre, Heath Park Caediff GB Other 510(k) Applications for this Company
Contact	DOMINIC GRIFFITHS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/2015
Decision Date	12/20/2016
Decision	DENG -
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review