510(k) K141958 ยท PCT Prostate Immobilizer Rectal Balloon
ERB ENDORECTAL BALLOON
| Applicant | Edge Medical, LLC, Lutsen MN, US |
| Decision | Substantially Equivalent, Nov 18, 2014 |
| Received | Jul 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141958
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.