510(k) K170606 ยท PLC Sleep Appliances With Patient Monitoring
Acrylic Herbst Appliance with Micro-Recorder
| Applicant | Gergen'S Orthodontic Lab, Phoenix AZ, US |
| Decision | Substantially Equivalent, Nov 16, 2017 |
| Received | Mar 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170606
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.