510(k) K981546 ยท MQC Mouthguard, Prescription
NTI CLENCHING SUPPRESSION SYSTEM
| Applicant | Heraeus Kulzer, Inc., South Bend IN, US |
| Decision | Substantially Equivalent, Jul 15, 1998 |
| Received | Apr 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981546
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.