The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Selectron Remote Isotope.
| Device ID | K810051 |
| 510k Number | K810051 |
| Device Name: | SELECTRON REMOTE ISOTOPE |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | VICTOREEN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-30 |
| Decision Date | 1981-02-02 |