Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K890102 |
Device Name |
ITC & ITE HEARING AID, HEAR CLEAR MODELS 1-4 |
Applicant |
HEAR CLEAR, INC. |
4401 TWAIN AVE. SUITE 5 |
SAN DIEGO,
CA
92120
|
|
Applicant Contact |
WARNER GLASSFORD |
Correspondent |
HEAR CLEAR, INC. |
4401 TWAIN AVE. SUITE 5 |
SAN DIEGO,
CA
92120
|
|
Correspondent Contact |
WARNER GLASSFORD |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 01/12/1989 |
Decision Date | 05/11/1989 |
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
|
|
|