510(k) K061122 ยท MQC Mouthguard, Prescription
NIGHT GUARD
| Applicant | Alpine Oral Care, LLC, Houston TX, US |
| Decision | Substantially Equivalent, Mar 12, 2007 |
| Received | Apr 24, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061122
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.