510(k) K170323 ยท KGC Tube, Gastro-Enterostomy
Entuit Start Initial Placement Gastrostomy Set
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Sep 14, 2017 |
| Received | Feb 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170323
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.