The following data is part of a premarket notification filed by Theragenics Corp. with the FDA for Theraload Custom Loaded Needles, Models 200 And 125.s06.
| Device ID | K043596 |
| 510k Number | K043596 |
| Device Name: | THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | THERAGENICS CORP. 5203 BRISTOL INDUSTRIAL WAY Buford, GA 30518 |
| Contact | Betsy Cortelloni |
| Correspondent | Betsy Cortelloni THERAGENICS CORP. 5203 BRISTOL INDUSTRIAL WAY Buford, GA 30518 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-29 |
| Decision Date | 2005-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813787021638 | K043596 | 000 |
| 00813787020495 | K043596 | 000 |
| 00813787020471 | K043596 | 000 |
| 00813787020464 | K043596 | 000 |
| 00813787020457 | K043596 | 000 |
| 00813787020440 | K043596 | 000 |
| 00813787020433 | K043596 | 000 |
| 00813787020419 | K043596 | 000 |
| 00813787020396 | K043596 | 000 |
| 00813787020389 | K043596 | 000 |
| 00813787020372 | K043596 | 000 |
| 00813787020365 | K043596 | 000 |
| 00813787020358 | K043596 | 000 |
| 00813787020327 | K043596 | 000 |
| 00813787020310 | K043596 | 000 |
| 00813787020778 | K043596 | 000 |
| 00813787020785 | K043596 | 000 |
| 00813787021614 | K043596 | 000 |
| 00813787020969 | K043596 | 000 |
| 00813787020945 | K043596 | 000 |
| 00813787020938 | K043596 | 000 |
| 00813787020921 | K043596 | 000 |
| 00813787020914 | K043596 | 000 |
| 00813787020907 | K043596 | 000 |
| 00813787020884 | K043596 | 000 |
| 00813787020860 | K043596 | 000 |
| 00813787020853 | K043596 | 000 |
| 00813787020846 | K043596 | 000 |
| 00813787020839 | K043596 | 000 |
| 00813787020822 | K043596 | 000 |
| 00813787020792 | K043596 | 000 |
| 00813787020303 | K043596 | 000 |