510(k) K112860 ยท KNT Tubes, Gastrointestinal (And Accessories)
PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Jun 8, 2012 |
| Received | Sep 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112860
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.