510(k) K112506 ยท LRC Instrument, Ent Manual Surgical
XPRESS MULTI-SINUS DILATION TOOL
| Applicant | Entellus Medical, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Dec 21, 2011 |
| Received | Aug 30, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112506
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.