K233056
- 510(k) number
- K233056
- Device name
- EpiZact
- Applicant
- Guidestar Medical Devices CA
- Product code
- FMF — Syringe, Piston
- Decision date
- 2023-11-02
- Date received
- 2023-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K233056.pdf
Official FDA record: K233056
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.