510(k) K012113 ยท KNT Tubes, Gastrointestinal (And Accessories)
INDWELLING FECAL MANAGEMENT SYSTEM
| Applicant | Bowel Management Systems, LLC, Indianapolis IN, US |
| Decision | Substantially Equivalent, May 3, 2002 |
| Received | Jul 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012113
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.