K230137
- 510(k) number
- K230137
- Device name
- Reliance® Fusion Sterilization Wraps
- Applicant
- Ahlstrom-Munksjo Nonwovens, LLC CT · US
- Product code
- FRG — Wrap, Sterilization
- Decision date
- 2023-12-07
- Date received
- 2023-01-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K230137.pdf
Official FDA record: K230137
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.