510(k) K190030 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Embrella Endoscopic Distal Attachment
| Applicant | Micro-Tech (Nanjing) Co., Ltd., Nanjing, CN |
| Decision | Substantially Equivalent, Mar 5, 2019 |
| Received | Jan 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190030
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.