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 |