Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K891594 |
Device Name |
CERUMEN FILTER |
Applicant |
GN DANAVOX, INC. |
6400 FLYING CLOUD DR. |
MINNEAPOLIS,
MN
55344
|
|
Applicant Contact |
MARSHALL ROSNER |
Correspondent |
GN DANAVOX, INC. |
6400 FLYING CLOUD DR. |
MINNEAPOLIS,
MN
55344
|
|
Correspondent Contact |
MARSHALL ROSNER |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 03/20/1989 |
Decision Date | 05/10/1989 |
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
|
|
|