K240330
- 510(k) number
- K240330
- Device name
- HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)
- Applicant
- O&M Halyard, Inc. VA · US
- Product code
- FRG — Wrap, Sterilization
- Decision date
- 2024-08-07
- Date received
- 2024-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K240330.pdf
Official FDA record: K240330
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.