510(k) K193602

LV Liberty Vision Model 1 90Yttrium Brachytherapy Source by Lv Liberty Vision Corporation — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2020
Date Received
December 23, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type