510(k) K192691 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
PatCom Single-Use Introducer
| Applicant | H&A Mui Enterprises, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Feb 21, 2020 |
| Received | Sep 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192691
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.