K232655
- 510(k) number
- K232655
- Device name
- Bonvadis®
- Applicant
- Stemcyte, Inc. CA · US
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2024-05-22
- Date received
- 2023-08-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232655.pdf
Official FDA record: K232655
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.