510(k) K103254 ยท KNT Tubes, Gastrointestinal (And Accessories)
PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Jan 31, 2011 |
| Received | Nov 3, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103254
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.