The following data is part of a premarket notification filed by Sourcetech Medical, L.l.c. with the FDA for 125-implant Seeds, Model Stm1250.
| Device ID | K991881 |
| 510k Number | K991881 |
| Device Name: | 125-IMPLANT SEEDS, MODEL STM1250 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | SOURCETECH MEDICAL, L.L.C. 295 E. LIES RD. Carol Stream, IL 60188 |
| Contact | David T Sieracki |
| Correspondent | David T Sieracki SOURCETECH MEDICAL, L.L.C. 295 E. LIES RD. Carol Stream, IL 60188 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-02 |
| Decision Date | 2000-03-16 |