510(k) K182520 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Flexible Overtube
| Applicant | Sumitomo Bakelite Co., Ltd., Shinagawa-Ku, JP |
| Decision | Substantially Equivalent, May 15, 2019 |
| Received | Sep 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182520
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.