The following data is part of a premarket notification filed by Keymed, Inc. with the FDA for Tri-dils-triple Olive-esophageal Dilator.
| Device ID | K830586 |
| 510k Number | K830586 |
| Device Name: | TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR |
| Classification | Dilator, Esophageal |
| Applicant | KEYMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-23 |
| Decision Date | 1983-03-24 |