510(k) K080871
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 2008
- Date Received
- March 31, 2008
- Clearance Type
- Special
- 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