The following data is part of a premarket notification filed by Medovations, Inc. with the FDA for Over The Guidewire Dilatation System.
| Device ID | K924646 |
| 510k Number | K924646 |
| Device Name: | OVER THE GUIDEWIRE DILATATION SYSTEM |
| Classification | Dilator, Esophageal |
| Applicant | MEDOVATIONS, INC. W194 N11340 MCCORMICK DR. Germantown, WI 53022 |
| Contact | Michael J Brown |
| Correspondent | Michael J Brown MEDOVATIONS, INC. W194 N11340 MCCORMICK DR. Germantown, WI 53022 |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-14 |
| Decision Date | 1994-12-05 |