510(k) K212728 ยท KNT Tubes, Gastrointestinal (And Accessories)
Standard Bougie, 38 Fr. and Hand Pump
| Applicant | Standard Bariatrics, Cincinnati OH, US |
| Decision | Substantially Equivalent, Sep 23, 2021 |
| Received | Aug 27, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212728
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.