510(k) K990323 ยท BXN Stimulator, Nerve, Battery-Powered
TE ME NA POLYSTIM NERVE STIMILATOR
| Applicant | Te ME NA S.A.R.L., Oldsmar FL, US |
| Decision | Substantially Equivalent, Sep 28, 2001 |
| Received | Feb 2, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990323
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation Poly Stim II Nerve Stimulator 8 inch for use with Stryker Pain Pump, REF 550-100, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
BXN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.