The following data is part of a premarket notification filed by Omnitron Intl., Inc. with the FDA for Ir-192 Implant -- Modification.
| Device ID | K923130 |
| 510k Number | K923130 |
| Device Name: | IR-192 IMPLANT -- MODIFICATION |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | OMNITRON INTL., INC. P.O. BOX 5247 3409 WEST PRIE LAKE ROAD Lajke Charles, LA 70606 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-25 |
| Decision Date | 1992-09-21 |