Device Classification Name |
Masker, Tinnitus
|
510(k) Number |
K091552 |
Device Name |
SWITCH TRT |
Applicant |
AUDIFON GMBH & CO. KG |
403 CHAIRMAN CT. |
SUITE 1 |
DEBARY,
FL
32713
|
|
Applicant Contact |
JANE PERRONE |
Correspondent |
AUDIFON GMBH & CO. KG |
403 CHAIRMAN CT. |
SUITE 1 |
DEBARY,
FL
32713
|
|
Correspondent Contact |
JANE PERRONE |
Regulation Number | 874.3400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/27/2009 |
Decision Date | 08/12/2009 |
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
|
|
|