510(k) K983515 ยท MQN External Mandibular Fixator And/Or Distractor
KLS INTRAORAL VERTICAL DISTRACTOR
| Applicant | KLS-Martin L.P., New Port Riche FL, US |
| Decision | Substantially Equivalent, Nov 30, 1998 |
| Received | Oct 7, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983515
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.