510(k) K170203
K170203 is an FDA 510(k) premarket notification submitted by Kobold, LLC for the device "System, Applicator, Radionuclide, Remote Controlled". The FDA issued a decision of Substantially Equivalent on Jun 1, 2017. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Kobold, LLC has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 1, 2017
- Date Received
- Jan 23, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Applicator, Radionuclide, Remote-Controlled
- Device Class
- Class II
- Regulation Number
- 892.5700
- Review Panel
- RA
- Submission Type
- 510(k)