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 | K183336 |
| 510k Number | K183336 |
| Device Name: | Entuit PEG, Entuit PEGJ |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem, NC 27105 |
| Contact | Tiffany A. Thomas |
| Correspondent | Tiffany A. Thomas Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem, NC 27105 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-03 |
| Decision Date | 2019-05-29 |