The following data is part of a premarket notification filed by Lv Liberty Vision Corporation with the FDA for Lv Liberty Vision Model 1 90yttrium Brachytherapy Source.
Device ID | K193602 |
510k Number | K193602 |
Device Name: | LV Liberty Vision Model 1 90Yttrium Brachytherapy Source |
Classification | Source, Brachytherapy, Radionuclide |
Applicant | LV Liberty Vision Corporation 300 West Road, Unit 2 Portsmouth, NH 03874 |
Contact | Paul T. Finger |
Correspondent | Paul T. Finger LV Liberty Vision Corporation 300 West Road, Unit 2 Portsmouth, NH 03874 |
Product Code | KXK |
CFR Regulation Number | 892.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-23 |
Decision Date | 2020-05-29 |