FDA 510(k) Application Details - K182053

Device Classification Name	More FDA Info for this Device
510(K) Number	K182053
Device Name	UltravisionÖ Visual Field Clearing System
Applicant	Alesi Surgical Ltd. Cardiff MediCentre, HeathPark Cardiff CF14 4UJ GB Other 510(k) Applications for this Company
Contact	David Broderick 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	07/31/2018
Decision Date	09/07/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review