The following data is part of a premarket notification filed by Midwest Metabolic Support Group with the FDA for K-tube.
| Device ID | K844745 |
| 510k Number | K844745 |
| Device Name: | K-TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MIDWEST METABOLIC SUPPORT GROUP 6000 WEST TOUHY AVE. Chicago, IL 60648 |
| Contact | John E Calderon |
| Correspondent | John E Calderon MIDWEST METABOLIC SUPPORT GROUP 6000 WEST TOUHY AVE. Chicago, IL 60648 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-06 |
| Decision Date | 1985-01-07 |