510(k) K193325 ยท KNT Tubes, Gastrointestinal (And Accessories)
Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches
| Applicant | Prosys International, Ltd., Wimbledon, GB |
| Decision | Substantially Equivalent, Mar 13, 2020 |
| Received | Dec 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193325
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.