510(k) K980953 ยท MQC Mouthguard, Prescription
ACCU-BITE HOME KIT DISCLUDER
| Applicant | Jerome M. Simon, Stamford CT, US |
| Decision | Substantially Equivalent, Oct 7, 1998 |
| Received | Mar 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980953
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.