Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K854311 |
Device Name |
EARLENS |
Applicant |
SOUND ACOUSTIC SYSTEMS, LTD. |
24861 ALICIA PKWY. |
SUITE C-302 |
LAGUNA,
CA
92653
|
|
Applicant Contact |
LEONARD H COHEN |
Correspondent |
SOUND ACOUSTIC SYSTEMS, LTD. |
24861 ALICIA PKWY. |
SUITE C-302 |
LAGUNA,
CA
92653
|
|
Correspondent Contact |
LEONARD H COHEN |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 10/25/1985 |
Decision Date | 04/14/1986 |
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
|
|
|