510(k) K182895 ยท PID Esophageal Dilator Balloon With Or Without Electrode Sensors
Wilson-Cook Achalasia Balloon
| Applicant | Wilson-Cook Medical, Inc., Winston-Salem NC, US |
| Decision | Substantially Equivalent, Jan 25, 2019 |
| Received | Oct 15, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182895
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.