The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Esophageal Dilator Set.
| Device ID | K842679 |
| 510k Number | K842679 |
| Device Name: | ESOPHAGEAL DILATOR SET |
| Classification | Bougie, Esophageal, And Gastrointestinal, Gastro-urology |
| Applicant | MILL-ROSE LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FAT |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-10 |
| Decision Date | 1984-10-02 |