510(k) K072296 ยท KXK Source, Brachytherapy, Radionuclide
POIINT OF CARE STRANDING SYSTEM, MODE 1004-00
| Applicant | Theragenics Corp., Buford GA, US |
| Decision | Substantially Equivalent, Sep 26, 2007 |
| Received | Aug 17, 2007 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K072296
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2009 | Theragenics Corporation Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140, TG3141 and TG3142. Theragenics Corporation, 5203 Bristol Industrial Way, Buford GA 30518.
The Terminated |
NQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.