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 | K170555 |
| 510k Number | K170555 |
| Device Name: | U Deliver Bolink ENFit Enteral Feeding Sets |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | U Deliver Medical, LLC 10150 City Walk Drive, Suite A Woodbury, MN 55129 |
| Contact | Brian Johnson |
| Correspondent | Roger Gray Donawa Lifescience Consulting S.r.l. Piazza Albania, 10 Rome, IT 00153 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-24 |
| Decision Date | 2017-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867622000449 | K170555 | 000 |
| 00867622000418 | K170555 | 000 |
| 00867622000401 | K170555 | 000 |