Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K890271 |
Device Name |
ALPHA MODEL I ITE HEARING AID |
Applicant |
ALPHA INSTRUMENTS, INC. |
611 SOUTH MAIN |
SIKESTON,
MO
63801
|
|
Applicant Contact |
BETTY ROBERTS |
Correspondent |
ALPHA INSTRUMENTS, INC. |
611 SOUTH MAIN |
SIKESTON,
MO
63801
|
|
Correspondent Contact |
BETTY ROBERTS |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 01/18/1989 |
Decision Date | 06/16/1989 |
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
|
|
|