K230707
- 510(k) number
- K230707
- Device name
- Skypro, Surgical Gown 6021
- Applicant
- Skypro Medical Supplies Company CN
- Product code
- FYA — Gown, Surgical
- Decision date
- 2023-10-12
- Date received
- 2023-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K230707.pdf
Official FDA record: K230707
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.