K251908
- 510(k) number
- K251908
- Device name
- Emanate Tray
- Applicant
- Emanate Biomedical NY · US
- Product code
- OLR — Oral Wound Dressing
- Decision date
- 2026-07-29
- Date received
- 2025-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251908.pdf
Official FDA record: K251908
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.