The following data is part of a premarket notification filed by Gbuk Enteral Limited with the FDA for Nutricare-isosaf Naso-gastric Feeding Tube.
| Device ID | K151503 |
| 510k Number | K151503 |
| Device Name: | NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | GBUK Enteral Limited Blackwood Hall Business Park, North Duffield Selby, GB Yo85dd |
| Contact | Mark Thompson |
| Correspondent | Leeanne Baker Advena Medical Pure Offices, Plato Close Warwick, GB Cv34 6we |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-04 |
| Decision Date | 2016-04-05 |