510(k) K171347 ยท PIF Gastrointestinal Tubes With Enteral Specific Connectors
Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
| Applicant | Xeridiem Medical Devices, Tucson AZ, US |
| Decision | Substantially Equivalent, Jun 6, 2017 |
| Received | May 8, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K171347
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.