| K-number | K964419 |
| Device name | MIRACLE - EAR (ITE/ITC/CIC) |
| Applicant | Miracle-Ear, Inc. |
| Product code | ESD |
| Device class | Class I |
| Decision date | Feb 4, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 874.3300 |
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