510(k) K181416 ยท LRK Device, Anti-Snoring
Sapphire Dorsal Comfort Fit
| Applicant | Crane Dental Laboratory, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Sep 17, 2019 |
| Received | May 31, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181416
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.