Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K791203 |
Device Name |
MODEL SE-1 EYEGLASS HEARING AID |
Applicant |
STARKEY LABORATORIES, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
STARKEY LABORATORIES, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 06/28/1979 |
Decision Date | 08/10/1979 |
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
|
|
|