510(k) DEN230011
- Device
- OcuCool
- Applicant
- Recensmedical, Inc.
- 510(k) number
- DEN230011
- Product code
- QZQ
- Decision
- Unknown (DENG)
- Decision date
- 2024-09-30
- Date received
- 2023-02-16
- Review panel
- Unknown
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Gun-Ho Kim
- Address
- #507, #908, Sk V1 Center, 830 Dongtansunhwan-Daero Hwaseong-Si KR 18468 18468
FDA Registration Numbers#
- 3015351183
Source Documents#
510(k) summary PDF not indicated by FDA