The following data is part of a premarket notification filed by Gbuk Group Ltd with the FDA for Enteral Extension Sets.
| Device ID | K203633 |
| 510k Number | K203633 |
| Device Name: | Enteral Extension Sets |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | GBUK Group Ltd Blackwood Hall Business Park, North Duffield Selby, GB Yo85dd |
| Contact | Lucy Islip |
| Correspondent | Chloe Kelly GBUK Group Ltd Blackwood Hall Business Park, North Duffield Selby, GB Yo85dd |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-11 |
| Decision Date | 2021-08-19 |