510(k) K201115 ยท LRC Instrument, Ent Manual Surgical
Next Generation Balloon Dilation System
| Applicant | Acclarent, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Aug 27, 2020 |
| Received | Apr 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201115
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.