Device Classification Name |
masker, tinnitus
|
510(k) Number |
K132965 |
Device Name |
SOLACE SOUND GENERATORS |
Applicant |
AMPLISOUND HEARING PRODUCTS & SERVICES |
594 PUTNAM ROAD |
DANIELSON,
CT
06239
|
|
Applicant Contact |
RALPH T CAMPAGNA |
Correspondent |
AMPLISOUND HEARING PRODUCTS & SERVICES |
594 PUTNAM ROAD |
DANIELSON,
CT
06239
|
|
Correspondent Contact |
RALPH T CAMPAGNA |
Regulation Number | 874.3400
|
Classification Product Code |
|
Date Received | 09/20/2013 |
Decision Date | 03/25/2014 |
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
|
|
|