510(k) K030832 ยท MQC Mouthguard, Prescription
PRIMOSPLINT SYSTEM
| Applicant | Cosmedent, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Sep 17, 2003 |
| Received | Mar 17, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030832
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.