K232968
- 510(k) number
- K232968
- Device name
- Grande Medical Masks, Model SF-600
- Applicant
- Golden Grande Corp. TW
- Product code
- FXX — Mask, Surgical
- Decision date
- 2024-06-06
- Date received
- 2023-09-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K232968.pdf
Official FDA record: K232968
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.