510(k) K163050 ยท MUI Media, Coupling, Ultrasound
Advance Medical Designs, Inc. Sterile Ultrasound Gel
| Applicant | Advance Medical Designs, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Oct 25, 2017 |
| Received | Nov 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163050
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.