K211943
- 510(k) number
- K211943
- Device name
- Microlyte Ag/Lidocaine
- Applicant
- Imbed Biosciences WI · US
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2024-10-17
- Date received
- 2021-06-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K211943.pdf
Official FDA record: K211943
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.