510(k) K213578 ยท FDF Colonoscope And Accessories, Flexible/Rigid
Balloon Dilatation Catheter
| Applicant | Hangzhou AGS MedTech Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Apr 6, 2022 |
| Received | Nov 10, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213578
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.