510(k) K052947 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE
| Applicant | Source Production & Equipment Co., Inc., Saint Rose LA, US |
| Decision | Substantially Equivalent, Apr 19, 2006 |
| Received | Oct 20, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052947
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2008 | Source Production & Equipment Inc M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA.
Brachytherapy source. Terminated |
KXK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.