510(k) K080355 ยท HAW Neurological Stereotaxic Instrument
LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
| Applicant | Elekta Instrument AB, Stockholm, SE |
| Decision | Substantially Equivalent, May 1, 2009 |
| Received | Feb 11, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080355
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.