Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K863975 |
Device Name |
CUSTOM IN-THE-EAR |
Applicant |
GN DANAVOX, INC. |
6400 FLYING CLOUD DR. |
MINNEAPOLIS,
MN
55344
|
|
Applicant Contact |
JAMES D GUTHIER |
Correspondent |
GN DANAVOX, INC. |
6400 FLYING CLOUD DR. |
MINNEAPOLIS,
MN
55344
|
|
Correspondent Contact |
JAMES D GUTHIER |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 10/14/1986 |
Decision Date | 11/07/1986 |
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
|
|
|