510(k) K112214 ยท GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS
| Applicant | St. Jude Medical Neuromodulation, Plano TX, US |
| Decision | Substantially Equivalent, Nov 17, 2011 |
| Received | Aug 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112214
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.