K850382 is an FDA 510(k) clearance for the IRIDIUM SEEDS. This device is classified as a Source, Wire, Iridium, Radioactive (Class II - Special Controls, product code IWA).
Submitted by Radiation Safety & Nuclear Products, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 15, 1985, 195 days after receiving the submission on February 1, 1985.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K850382 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 1985 |
| Decision Date | August 15, 1985 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IWA — Source, Wire, Iridium, Radioactive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5730 |