OcuCool
FDA 510(k) clearance DEN230011 · decided 2024-09-30
Clearance details
- K-number
- DEN230011
- Device name
- OcuCool
- Applicant
- Recensmedical, Inc.
- Decision
- Unknown
- Date received
- 2023-02-16
- Decision date
- 2024-09-30
- Days to decision
- 592 days
- Clearance type
- Direct
- Product code
- QZQ
- Advisory committee
- Unknown
- Location
- Hwaseong-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.