Emanate Tray
FDA 510(k) clearance K251908 · decided 2026-07-29
Clearance details
- K-number
- K251908
- Device name
- Emanate Tray
- Applicant
- Emanate Biomedical
- Decision
- Substantially Equivalent
- Date received
- 2025-06-20
- Decision date
- 2026-07-29
- Days to decision
- 404 days
- Clearance type
- Traditional
- Product code
- OLR
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.