Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K940667 |
Device Name |
STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID |
Applicant |
STARKEY LABORATORIES, INC. |
6700 WASHINGTON AVE. SOUTH |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
RICK STROMBERG |
Correspondent |
STARKEY LABORATORIES, INC. |
6700 WASHINGTON AVE. SOUTH |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
RICK STROMBERG |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 02/16/1994 |
Decision Date | 08/09/1994 |
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
|
|
|