The following data is part of a premarket notification filed by U Deliver Medical, Llc with the FDA for U Deliver Bolink Enfit Enteral Feeding Sets.
| Device ID | K190310 |
| 510k Number | K190310 |
| Device Name: | U Deliver Bolink ENFit Enteral Feeding Sets |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | U Deliver Medical, LLC 7900 Excelsior Blvd Suite 108 Hopkins, MN 55343 |
| Contact | Brian Johnson |
| Correspondent | Thomas Dold Vista Regulatory Solutions, LLC 18205 E. Sioux Vista Dr. Jordan, MN 55352 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-12 |
| Decision Date | 2019-05-31 |