The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Mclean-ring Enteral Feeding Tube Set.
| Device ID | K190084 |
| 510k Number | K190084 |
| Device Name: | McLean-Ring Enteral Feeding Tube Set |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Paul Meyer |
| Correspondent | Paul Meyer Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-17 |
| Decision Date | 2019-10-11 |
| Summary: | summary |