K250321
- 510(k) number
- K250321
- Device name
- GCI Sterilization Wrappers
- Applicant
- George Courey, Inc. CA
- Product code
- FRG — Wrap, Sterilization
- Decision date
- 2025-06-06
- Date received
- 2025-02-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K250321.pdf
Official FDA record: K250321
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.