Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K940164 |
Device Name |
SUPER-SIL |
Applicant |
FINETONE HEARING INSTRUMENTS |
200 JOHN ROBERTS RD. |
SOUTH PORTLAND,
ME
04106
|
|
Applicant Contact |
JEFFREY A MCLAUGHLIN |
Correspondent |
FINETONE HEARING INSTRUMENTS |
200 JOHN ROBERTS RD. |
SOUTH PORTLAND,
ME
04106
|
|
Correspondent Contact |
JEFFREY A MCLAUGHLIN |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 01/06/1994 |
Decision Date | 06/29/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|