K211676
- 510(k) number
- K211676
- Device name
- Motiva Flora SmoothSilk Tissue Expander
- Applicant
- Motiva USA, LLC CA · US
- Product code
- LCJ — Tissue Expander And Accessories
- Decision date
- 2023-10-13
- Date received
- 2021-06-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain
Also available from FDA: K211676.pdf
Official FDA record: K211676
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.