Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K903145 |
Device Name |
HEARSET TELEPHONE HEARING SYSTEM |
Applicant |
STARKEY LABORATORIES, INC. |
6700 WASHINGTON AVE. SOUTH |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
JERROLD LANG |
Correspondent |
STARKEY LABORATORIES, INC. |
6700 WASHINGTON AVE. SOUTH |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
JERROLD LANG |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 07/18/1990 |
Decision Date | 12/21/1990 |
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
|
|
|