510(k) K181643 ยท EXB Collector, Ostomy
SmartBag (SmartPouch)
| Applicant | 11 Health Technologies Limited, Borehamwood, GB |
| Decision | Substantially Equivalent, Nov 16, 2018 |
| Received | Jun 22, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181643
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.