510(k) K111828 ยท MQC Mouthguard, Prescription
CLEARSPLINT ES
| Applicant | Astron Dental Corporation, Lake Zurich IL, US |
| Decision | Substantially Equivalent, Oct 26, 2011 |
| Received | Jun 28, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111828
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.