510(k) K832738
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1983
- Date Received
- August 12, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Applicator, Radionuclide, Manual
- Device Class
- Class I
- Regulation Number
- 892.5650
- Review Panel
- RA
- Submission Type