The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Miracle - Ear Model Pbp.
Device ID | K954528 |
510k Number | K954528 |
Device Name: | MIRACLE - EAR MODEL PBP |
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 | 1995-09-29 |
Decision Date | 1995-10-07 |