Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K905784 |
Device Name |
CUSTOM ITE HEARING AID |
Applicant |
HEARING AID CO. |
1188 BISHOP ST. |
SUITE 2402 |
HONOLULU,
HI
96813
|
|
Applicant Contact |
RANDY WOHLERS |
Correspondent |
HEARING AID CO. |
1188 BISHOP ST. |
SUITE 2402 |
HONOLULU,
HI
96813
|
|
Correspondent Contact |
RANDY WOHLERS |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 12/18/1990 |
Decision Date | 03/18/1991 |
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
|
|
|