Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K920093 |
Device Name |
AUDIOTONE MODEL A-96 |
Applicant |
MIRACLE-EAR, INC. |
4101 DAHLBERG DR. |
GOLDEN VALLEY,
MN
55422
|
|
Applicant Contact |
KEVIN L KUTINA |
Correspondent |
MIRACLE-EAR, INC. |
4101 DAHLBERG DR. |
GOLDEN VALLEY,
MN
55422
|
|
Correspondent Contact |
KEVIN L KUTINA |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 01/08/1992 |
Decision Date | 01/30/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|