510(k) K032790
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 2003
- Date Received
- September 8, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Block, Beam-Shaping, Radiation Therapy
- Device Class
- Class II
- Regulation Number
- 892.5710
- Review Panel
- RA
- Submission Type