The following data is part of a premarket notification filed by Medovations, Inc. with the FDA for Medovations Esophageal Dilator.
| Device ID | K002363 |
| 510k Number | K002363 |
| Device Name: | MEDOVATIONS ESOPHAGEAL DILATOR |
| Classification | Dilator, Esophageal |
| Applicant | MEDOVATIONS, INC. 1294 BARCLAY BLVD. Buffalo Grove, IL 60089 |
| Contact | Michael J Brown |
| Correspondent | Michael J Brown MEDOVATIONS, INC. 1294 BARCLAY BLVD. Buffalo Grove, IL 60089 |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-03 |
| Decision Date | 2000-11-01 |