510(k) K023179
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2003
- Date Received
- September 24, 2002
- Clearance Type
- Traditional
- 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