Device Classification Name |
Masker, Tinnitus
|
510(k) Number |
K030180 |
Device Name |
CRESCENT TINNITUS RETAINING SOUND GENERATOR |
Applicant |
STARKEY LABORATORIES, INC. |
6700 WASHINGTON AVE. SOUTH |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
SCOTT LAPOINTE |
Correspondent |
STARKEY LABORATORIES, INC. |
6700 WASHINGTON AVE. SOUTH |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
SCOTT LAPOINTE |
Regulation Number | 874.3400
|
Classification Product Code |
|
Date Received | 01/17/2003 |
Decision Date | 09/17/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|