De Novo Number |
DEN230011 |
Device Name |
OcuCool |
Requester |
recensmedical, inc. |
#507, #908, sk v1 center |
830 dongtansunhwan-daero |
hwaseong-si,
KR
18468
|
|
Contact |
gun-ho kim |
|
Classification Product Code |
|
Date Received | 02/16/2023 |
Decision Date | 09/30/2024 |
Decision |
granted
(DENG) |
Review Advisory Committee |
Ophthalmic
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|