510(k) K193602
K193602 is an FDA 510(k) premarket notification submitted by Lv Liberty Vision Corporation for the device "LV Liberty Vision Model 1 90Yttrium Brachytherapy Source". The FDA issued a decision of Substantially Equivalent on May 29, 2020. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730.
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