510(k) K240463 ยท MQC Mouthguard, Prescription
Slow Wave DS8 (SWDS802)
| Applicant | Slow Wave, Inc., Spicewood TX, US |
| Decision | Substantially Equivalent, Jun 4, 2024 |
| Received | Feb 16, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240463
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.