K233262
- 510(k) number
- K233262
- Device name
- Dukal SMS Sterilization Wrap
- Applicant
- Dukal, LLC NY · US
- Product code
- FRG — Wrap, Sterilization
- Decision date
- 2024-03-22
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K233262.pdf
Official FDA record: K233262
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.