The following data is part of a premarket notification filed by Hedeco with the FDA for Rombeau Gastrostomy-jejunal Tube.
| Device ID | K822380 |
| 510k Number | K822380 |
| Device Name: | ROMBEAU GASTROSTOMY-JEJUNAL TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | HEDECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-09 |
| Decision Date | 1982-09-17 |