Device Classification Name |
Masker, Tinnitus
|
510(k) Number |
K924991 |
Device Name |
MICRO MASKER |
Applicant |
ASSOCIATED HEARING INSTRUMENTS |
6796 MARKET ST. |
UPPER DARBY,
PA
19082
|
|
Applicant Contact |
ROBERT LIBBY |
Correspondent |
ASSOCIATED HEARING INSTRUMENTS |
6796 MARKET ST. |
UPPER DARBY,
PA
19082
|
|
Correspondent Contact |
ROBERT LIBBY |
Regulation Number | 874.3400
|
Classification Product Code |
|
Date Received | 10/01/1992 |
Decision Date | 06/14/1993 |
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
|
|
|