Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K900050 |
Device Name |
MIRACLE EAR MODEL CK IN-THE-EAR HEARING AID |
Applicant |
MIRACLE-EAR, INC. |
600 SOUTH COUNTY RD. 18 |
MINNEAPOLIS,
MN
55426
|
|
Applicant Contact |
L KUTINA |
Correspondent |
MIRACLE-EAR, INC. |
600 SOUTH COUNTY RD. 18 |
MINNEAPOLIS,
MN
55426
|
|
Correspondent Contact |
L KUTINA |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 01/03/1990 |
Decision Date | 03/14/1990 |
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
|
|
|