The following data is part of a premarket notification filed by Lv Liberty Vision Corp. with the FDA for Lv Liberty Vision Model 1 90 Yttrium Brachytherapy Source.
Device ID | K163572 |
510k Number | K163572 |
Device Name: | LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source |
Classification | Source, Brachytherapy, Radionuclide |
Applicant | LV Liberty Vision Corp. 155 Fleet Street Portsmouth, NH 03801 |
Contact | Paul T. Finger |
Correspondent | Paul T. Finger LV Liberty Vision Corp. 155 Fleet Street Portsmouth, NH 03801 |
Product Code | KXK |
CFR Regulation Number | 892.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-19 |
Decision Date | 2017-03-15 |
Summary: | summary |