510(k) K140310 ยท KNT Tubes, Gastrointestinal (And Accessories)
Peristeen Anal Irrigation System
| Applicant | Coloplast A/S, Minneapolis MN, US |
| Decision | Substantially Equivalent, Sep 3, 2015 |
| Received | Feb 7, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140310
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.