510(k) K041718 ยท DZB Headgear, Extraoral, Orthodontic
KELES FACEMASK
| Applicant | Great Lakes Orthodontics, Ltd., Tonawanda NY, US |
| Decision | Substantially Equivalent, Oct 15, 2004 |
| Received | Jun 24, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041718
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.