Device Classification Name |
tympanic membrane direct contact hearing aid
|
De Novo Number |
DEN150002 |
Device Name |
EarLens Contact Hearing Device |
Requester |
EARLENS CORPORATION |
4045-a cambbell avenue |
menlo park,
CA
94025
|
|
Contact |
suzanne levy |
|
Regulation Number | 874.3315
|
Classification Product Code |
|
Date Received | 01/02/2015 |
Decision Date | 09/29/2015 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Ear Nose & Throat
|
Review Advisory Committee |
Ear Nose & Throat
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|