Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K913366 |
Device Name |
IN-THE-EAR HEARING AIDS |
Applicant |
FENWICK HEARING INSTRUMENTS |
2188 S.W. PARK PLACE, |
SUITE 101 |
PORTLAND,
OR
97205
|
|
Applicant Contact |
JAMES A FENWICK |
Correspondent |
FENWICK HEARING INSTRUMENTS |
2188 S.W. PARK PLACE, |
SUITE 101 |
PORTLAND,
OR
97205
|
|
Correspondent Contact |
JAMES A FENWICK |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 07/29/1991 |
Decision Date | 11/05/1991 |
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
|
|
|