The following data is part of a premarket notification filed by Theragenics Corp. with the FDA for Poiint Of Care Stranding System, Mode 1004-00.
| Device ID | K072296 |
| 510k Number | K072296 |
| Device Name: | POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-17 |
| Decision Date | 2007-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813787020662 | K072296 | 000 |
| 00813787020655 | K072296 | 000 |
| 00813787020648 | K072296 | 000 |
| 00813787020204 | K072296 | 000 |
| 00813787020198 | K072296 | 000 |
| 00813787020181 | K072296 | 000 |