The following data is part of a premarket notification filed by Midwest Metabolic Support Group with the FDA for Pediatric Size K-tube A Or B.
| Device ID | K843939 |
| 510k Number | K843939 |
| Device Name: | PEDIATRIC SIZE K-TUBE A OR B |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MIDWEST METABOLIC SUPPORT GROUP 6000 WEST TOUHY AVE. Chicago, IL 60648 |
| Contact | John Calderon |
| Correspondent | John 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 | 1984-10-09 |
| Decision Date | 1985-02-14 |