510(k) K181838 ยท LRC Instrument, Ent Manual Surgical
Sinusway Dilation System
| Applicant | 3nt Medical , Ltd., Rosh Ha'Ayin, IL |
| Decision | Substantially Equivalent, Dec 20, 2018 |
| Received | Jul 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181838
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.