The following data is part of a premarket notification filed by Theragenics Corp. with the FDA for I-seed.
| Device ID | K103319 |
| 510k Number | K103319 |
| Device Name: | I-SEED |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | THERAGENICS CORP. 5203 BRISTOL INDUSTRIAL WAY Buford, GA 30518 |
| Contact | Besty Cortelloni |
| Correspondent | Besty Cortelloni THERAGENICS CORP. 5203 BRISTOL INDUSTRIAL WAY Buford, GA 30518 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-12 |
| Decision Date | 2011-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813787020341 | K103319 | 000 |
| 00813787020129 | K103319 | 000 |
| 00813787020112 | K103319 | 000 |
| 00813787020105 | K103319 | 000 |
| 00813787020099 | K103319 | 000 |
| 00813787020082 | K103319 | 000 |
| 00813787020075 | K103319 | 000 |
| 00813787020068 | K103319 | 000 |
| 00813787020051 | K103319 | 000 |
| 00813787020044 | K103319 | 000 |
| 00813787020037 | K103319 | 000 |
| 00813787020136 | K103319 | 000 |
| 00813787020143 | K103319 | 000 |
| 00813787020150 | K103319 | 000 |
| 00813787020334 | K103319 | 000 |
| 00813787020273 | K103319 | 000 |
| 00813787020266 | K103319 | 000 |
| 00813787020259 | K103319 | 000 |
| 00813787020242 | K103319 | 000 |
| 00813787020235 | K103319 | 000 |
| 00813787020228 | K103319 | 000 |
| 00813787020211 | K103319 | 000 |
| 00813787020174 | K103319 | 000 |
| 00813787020167 | K103319 | 000 |
| 00813787020020 | K103319 | 000 |