K234050
- 510(k) number
- K234050
- Device name
- HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap
- Applicant
- O&M Halyard, Inc. VA · US
- Product code
- FRG — Wrap, Sterilization
- Decision date
- 2024-09-16
- Date received
- 2023-12-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K234050.pdf
Official FDA record: K234050
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.