510(k) K043434 ยท MQN External Mandibular Fixator And/Or Distractor
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM
| Applicant | Osteomed LP, Addison TX, US |
| Decision | Substantially Equivalent, Feb 10, 2005 |
| Received | Dec 13, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043434
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.