510(k) K932242
K932242 is an FDA 510(k) premarket notification submitted by Best Industries for the device "RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345". The FDA issued a decision of Substantially Equivalent on July 27, 1993. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Best Industries has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1993
- Date Received
- May 7, 1993
- 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