K233571
- 510(k) number
- K233571
- Device name
- GCI Surgical Gown
- Applicant
- George Courey, Inc. CA
- Product code
- FYA — Gown, Surgical
- Decision date
- 2024-08-02
- Date received
- 2023-11-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K233571.pdf
Official FDA record: K233571
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.