510(k) K083770 ยท KNT Tubes, Gastrointestinal (And Accessories)
COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM
| Applicant | Coloplast A/S, Minneapolis MN, US |
| Decision | Substantially Equivalent, Nov 23, 2009 |
| Received | Dec 18, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083770
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.