K241283
- 510(k) number
- K241283
- Device name
- Elemental Granulate
- Applicant
- Zinkh NV BE
- Product code
- OLR — Oral Wound Dressing
- Decision date
- 2025-01-03
- Date received
- 2024-05-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K241283.pdf
Official FDA record: K241283
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.