The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Entuit Peg, Entuit Pegj.
| Device ID | K213356 |
| 510k Number | K213356 |
| Device Name: | Entuit PEG, Entuit PEGJ |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-salem, NC 27105 |
| Contact | Tiffanny A. Thomas |
| Correspondent | Tiffanny A. Thomas Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-salem, NC 27105 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-12 |
| Decision Date | 2022-01-20 |