The following data is part of a premarket notification filed by Gbuk Group Ltd with the FDA for Enteral Transition Adaptor.
| Device ID | K220165 |
| 510k Number | K220165 |
| Device Name: | Enteral Transition Adaptor |
| Classification | Enteral Specific Transition Connectors |
| Applicant | GBUK Group Ltd Blackwood Hall Business Park, North Duffield Selby, GB YO85DD |
| Contact | Rachael Hume |
| Correspondent | Rachael Hume GBUK Group Ltd Blackwood Hall Business Park, North Duffield Selby, GB YO85DD |
| Product Code | PIO |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-20 |
| Decision Date | 2022-10-21 |