Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K870080 |
Device Name |
MICRO-EAR FULL-CONCHA IN-THE-EAR HEARING AID |
Applicant |
MICRO-EAR HEARING CENTER, INC. |
4933 FRANCE AVENUE SO. |
MINNEAPOLIS,
MN
55410
|
|
Applicant Contact |
HAGEN, M.A. |
Correspondent |
MICRO-EAR HEARING CENTER, INC. |
4933 FRANCE AVENUE SO. |
MINNEAPOLIS,
MN
55410
|
|
Correspondent Contact |
HAGEN, M.A. |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 01/08/1987 |
Decision Date | 03/03/1987 |
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
|
|
|