K932242 is an FDA 510(k) clearance for the RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345. This device is classified as a Source, Brachytherapy, Radionuclide (Class II - Special Controls, product code KXK).
Submitted by Best Industries (Springfield, US). The FDA issued a Cleared decision on July 27, 1993, 81 days after receiving the submission on May 7, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K932242 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 1993 |
| Decision Date | July 27, 1993 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | KXK — Source, Brachytherapy, Radionuclide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5730 |