Device Classification Name |
Face Plate Hearing Aid
|
510(k) Number |
K910901 |
Device Name |
FACEPLATE ITE HEARING AID MODEL 28A |
Applicant |
TELEX COMMUNICATIONS, INC. |
9600 ALDRICH AVENUE SOUTH |
MINNEAPOLIS,
MN
55420
|
|
Applicant Contact |
HARRY TEDER |
Correspondent |
TELEX COMMUNICATIONS, INC. |
9600 ALDRICH AVENUE SOUTH |
MINNEAPOLIS,
MN
55420
|
|
Correspondent Contact |
HARRY TEDER |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 03/05/1991 |
Decision Date | 05/30/1991 |
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
|
|
|