MIRACLE-EAR CONFIDANTE
Hearing Aid, Air Conduction
MIRACLE-EAR, INC.
The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Miracle-ear Confidante.
Pre-market Notification Details
| Device ID | K940458 |
| 510k Number | K940458 |
| Device Name: | MIRACLE-EAR CONFIDANTE |
| Classification | Hearing Aid, Air Conduction |
| Applicant | MIRACLE-EAR, INC. 4101 DAHLBERG DR. Golden Valley, MN 55422 |
| Contact | Melanie Raska |
| Correspondent | Melanie Raska MIRACLE-EAR, INC. 4101 DAHLBERG DR. Golden Valley, MN 55422 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-01 |
| Decision Date | 1994-03-21 |
Trademark Results [MIRACLE-EAR CONFIDANTE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MIRACLE-EAR CONFIDANTE 75907868 2503031 Dead/Cancelled |
Miracle-Ear, Inc. 2000-02-02 |
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