510(k) DEN230011
DEN230011 is an FDA 510(k) premarket notification submitted by Recensmedical, Inc. for the device "OcuCool". The FDA issued a decision of De Novo Granted on September 30, 2024. Recensmedical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 30, 2024
- Date Received
- February 16, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No