The following data is part of a premarket notification filed by Exercore, Llc with the FDA for Eustachi Ear Pressure Relief Device.
| Device ID | K203754 |
| 510k Number | K203754 |
| Device Name: | Eustachi Ear Pressure Relief Device |
| Classification | Device, Inflation, Middle Ear |
| Applicant | Exercore, LLC 8170 Old Carriage Court N, Suite 200 Shakopee, MN 55379 |
| Contact | Kevin Connelly |
| Correspondent | Lisa Pritchard DuVal & Associates, P.A. 825 Nicollet Mall, Suite 1840 Minneapolis, MN 55402 |
| Product Code | MJV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-23 |
| Decision Date | 2021-02-19 |