Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K894428 |
Device Name |
HEARING AID (IN-THE-EAR) |
Applicant |
HEARING AID EXPRESS |
2877 LBJ FREEWAY, STE. 160 |
DALLAS,
TX
75234
|
|
Applicant Contact |
MCGINNAS, JR. |
Correspondent |
HEARING AID EXPRESS |
2877 LBJ FREEWAY, STE. 160 |
DALLAS,
TX
75234
|
|
Correspondent Contact |
MCGINNAS, JR. |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 07/17/1989 |
Decision Date | 10/24/1989 |
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
|
|
|