510(k) K152434 ยท LRC Instrument, Ent Manual Surgical
XprESS Multi-Sinus Dilation System
| Applicant | Entellus Medical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Nov 20, 2015 |
| Received | Aug 27, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152434
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.