Device Classification Name |
Face Plate Hearing Aid
|
510(k) Number |
K897023 |
Device Name |
OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID |
Applicant |
AUDINA HEARING INSTRUMENT |
150 WILDMERE ST. |
LONGWOOD,
FL
32750
|
|
Applicant Contact |
FRANK J ROBILOTTA |
Correspondent |
AUDINA HEARING INSTRUMENT |
150 WILDMERE ST. |
LONGWOOD,
FL
32750
|
|
Correspondent Contact |
FRANK J ROBILOTTA |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 12/19/1989 |
Decision Date | 03/16/1990 |
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
|
|
|