510(k) K191836 ยท MQC Mouthguard, Prescription
Ceramill A-Splint
| Applicant | Amann Girrbach AG, Koblach, AT |
| Decision | Substantially Equivalent, Dec 20, 2019 |
| Received | Jul 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191836
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.