510(k) K190114 ยท KNT Tubes, Gastrointestinal (And Accessories)
Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
| Applicant | Convatec Limited, Deeside, GB |
| Decision | Substantially Equivalent, Apr 30, 2019 |
| Received | Jan 24, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190114
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.