Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K872977 |
Device Name |
HEARING AID (ALL-IN-THE-EAR) |
Applicant |
THE HOUR GLASS |
MARKET SQUARE |
1415 TIMBERLANE ROAD |
TALLAHASSEE,
FL
32312
|
|
Applicant Contact |
ALICE STEPHENS |
Correspondent |
THE HOUR GLASS |
MARKET SQUARE |
1415 TIMBERLANE ROAD |
TALLAHASSEE,
FL
32312
|
|
Correspondent Contact |
ALICE STEPHENS |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 07/30/1987 |
Decision Date | 09/16/1987 |
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
|
|
|