510(k) K023344 ยท KNT Tubes, Gastrointestinal (And Accessories)
INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE
| Applicant | Bowel Management Systems, LLC, Fernandina Beach FL, US |
| Decision | Substantially Equivalent, Nov 6, 2002 |
| Received | Oct 7, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023344
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.