510(k) K193612 ยท KGC Tube, Gastro-Enterostomy
AMT Suture Delivery System
| Applicant | Applied Medical Technology, Inc., Brecksville OH, US |
| Decision | Substantially Equivalent, Mar 12, 2020 |
| Received | Dec 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193612
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.