510(k) K121943 ยท LRC Instrument, Ent Manual Surgical
XPRESS MULTI-SINUS DILATION TOOL
| Applicant | Entellus Medical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Aug 22, 2012 |
| Received | Jul 3, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121943
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.