Device Classification Name |
tear duct occluder
|
De Novo Number |
DEN140022 |
Device Name |
GLAUCOMA COMPANION |
Requester |
innovatex, inc. |
150 buckskin dr. |
weston,
MA
02493
|
|
Contact |
stephen c chen |
|
Regulation Number | 886.5838
|
Classification Product Code |
|
Date Received | 07/18/2014 |
Decision Date | 04/20/2016 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Ophthalmic
|
Review Advisory Committee |
Ophthalmic
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|