Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K915794 |
Device Name |
AD-HEAR |
Applicant |
HEARING COMPONENTS, INC. |
200 CRESTVIEW DR. |
MAPLEWOOD,
MN
55119
|
|
Applicant Contact |
DEANNA OLIVEIRA |
Correspondent |
HEARING COMPONENTS, INC. |
200 CRESTVIEW DR. |
MAPLEWOOD,
MN
55119
|
|
Correspondent Contact |
DEANNA OLIVEIRA |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 12/24/1991 |
Decision Date | 03/12/1992 |
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
|
|
|