Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K905680 |
Device Name |
543 SERIES BTE |
Applicant |
HEARING TECH, INC. |
5600 ROWLAND RD. |
SUITE 250 |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
WAYNE MORRIS |
Correspondent |
HEARING TECH, INC. |
5600 ROWLAND RD. |
SUITE 250 |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
WAYNE MORRIS |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 12/19/1990 |
Decision Date | 03/08/1991 |
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
|
|
|