The following data is part of a premarket notification filed by Theragenics Corp. with the FDA for Theraseed(r) Palladium-103 Implant; Model 200.
| Device ID | K010283 |
| 510k Number | K010283 |
| Device Name: | THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | THERAGENICS CORP. 5203 BRISTOL INDUSTRIAL WAY Buford, GA 30518 |
| Contact | Janet E Zeman |
| Correspondent | Janet E Zeman THERAGENICS CORP. 5203 BRISTOL INDUSTRIAL WAY Buford, GA 30518 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-30 |
| Decision Date | 2001-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741078484 | K010283 | 000 |
| 00813787020617 | K010283 | 000 |
| 00813787020600 | K010283 | 000 |
| 00813787020594 | K010283 | 000 |
| 00813787020587 | K010283 | 000 |
| 00813787020570 | K010283 | 000 |
| 00813787020563 | K010283 | 000 |
| 00813787020556 | K010283 | 000 |
| 00813787020549 | K010283 | 000 |
| 00813787020532 | K010283 | 000 |
| 00813787020525 | K010283 | 000 |
| 00813787020518 | K010283 | 000 |
| 00813787020013 | K010283 | 000 |
| 00813787020624 | K010283 | 000 |
| 00813787020631 | K010283 | 000 |
| 00813787020679 | K010283 | 000 |
| 00801741078477 | K010283 | 000 |
| 00801741078392 | K010283 | 000 |
| 00801741078385 | K010283 | 000 |
| 00813787020815 | K010283 | 000 |
| 00813787020808 | K010283 | 000 |
| 00813787020747 | K010283 | 000 |
| 00813787020730 | K010283 | 000 |
| 00813787020723 | K010283 | 000 |
| 00813787020716 | K010283 | 000 |
| 00813787020709 | K010283 | 000 |
| 00813787020693 | K010283 | 000 |
| 00813787020686 | K010283 | 000 |
| 00813787020006 | K010283 | 000 |