Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K954937 |
Device Name |
COAST HEARING CHS (CUSTOM HEARING SYSTEM) |
Applicant |
COAST HEARING SERVICES |
904 S.W. BAY ST. |
NEWPORT,
OR
97365
|
|
Applicant Contact |
LE'ANNE MCEACHERN |
Correspondent |
COAST HEARING SERVICES |
904 S.W. BAY ST. |
NEWPORT,
OR
97365
|
|
Correspondent Contact |
LE'ANNE MCEACHERN |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 05/08/1995 |
Decision Date | 11/13/1995 |
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
|
|
|