Device Classification Name |
Masker, Tinnitus
|
510(k) Number |
K070599 |
Device Name |
CUSTOMIZED SOUND THERAPY (CST) |
Applicant |
TINNITUS OTOSOUND PRODUCTS, LLC |
880 FIRST ST., SUITE 403 |
LOS ANGELES,
CA
90012
|
|
Applicant Contact |
GERALDINE CREAN |
Correspondent |
TINNITUS OTOSOUND PRODUCTS, LLC |
880 FIRST ST., SUITE 403 |
LOS ANGELES,
CA
90012
|
|
Correspondent Contact |
GERALDINE CREAN |
Regulation Number | 874.3400
|
Classification Product Code |
|
Date Received | 03/02/2007 |
Decision Date | 07/13/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|