510(k) K192661 ยท NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
LATERA Absorbable Nasal Implant System
| Applicant | Entellus Medical, Inc. (Aka Stryker Ent), Plymouth MN, US |
| Decision | Substantially Equivalent, Nov 10, 2019 |
| Received | Sep 25, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192661
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.