510(k) K010008 ยท GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX
| Applicant | Micronet Medical, Inc., White Bear Lake, MN, US |
| Decision | Substantially Equivalent, Jul 16, 2001 |
| Received | Jan 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010008
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.