Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K895368 |
Device Name |
IN THE EAR HEARING AID |
Applicant |
HEARING CRAFTERS OF AMERICA |
RT. 1 |
BOX 190 |
MT. VERNON,
MO
65712
|
|
Applicant Contact |
JEAN GUISON |
Correspondent |
HEARING CRAFTERS OF AMERICA |
RT. 1 |
BOX 190 |
MT. VERNON,
MO
65712
|
|
Correspondent Contact |
JEAN GUISON |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 08/29/1989 |
Decision Date | 03/05/1990 |
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
|
|
|