510(k) K013618 ยท MQN External Mandibular Fixator And/Or Distractor
INTRAORAL MANDIBULAR DISTRACTION SYSTEM
| Applicant | Osteomed Corp., Addison TX, US |
| Decision | Substantially Equivalent, Aug 14, 2002 |
| Received | Nov 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013618
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.