Device Classification Name |
face plate hearing aid
|
510(k) Number |
K974219 |
Device Name |
FACEPLATE ASSEMBLY |
Applicant |
FINETONE HEARING INSTRUMENTS |
301 U.S. RT. 1 |
SCARBOROUGH,
ME
04074
|
|
Applicant Contact |
PAUL MENEZES |
Correspondent |
FINETONE HEARING INSTRUMENTS |
301 U.S. RT. 1 |
SCARBOROUGH,
ME
04074
|
|
Correspondent Contact |
PAUL MENEZES |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 11/10/1997 |
Decision Date | 02/20/1998 |
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
|
|
|