K252823
- 510(k) number
- K252823
- Device name
- Dukal Crepe Paper Sterilization Wrap
- Applicant
- Dukal, LLC NY · US
- Product code
- FRG — Wrap, Sterilization
- Decision date
- 2026-05-28
- Date received
- 2025-09-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K252823.pdf
Official FDA record: K252823
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.