The following data is part of a premarket notification filed by Radiation Safety & Nuclear Products, Inc. with the FDA for Iridium Seeds.
| Device ID | K850382 |
| 510k Number | K850382 |
| Device Name: | IRIDIUM SEEDS |
| Classification | Source, Wire, Iridium, Radioactive |
| Applicant | RADIATION SAFETY & NUCLEAR PRODUCTS, INC. 3641 WEST 1987 SOUTH Salt Lake City, UT 84104 |
| Contact | Edd Johnson |
| Correspondent | Edd Johnson RADIATION SAFETY & NUCLEAR PRODUCTS, INC. 3641 WEST 1987 SOUTH Salt Lake City, UT 84104 |
| Product Code | IWA |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-01 |
| Decision Date | 1985-08-15 |