510(k) K181396 ยท LRK Device, Anti-Snoring
Oral Device OA, Oral Device S
| Applicant | Passion For Life Healthcare (Uk) Limited, Ellesmere Port, GB |
| Decision | Substantially Equivalent, Nov 16, 2018 |
| Received | May 29, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181396
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.