K213473
- 510(k) number
- K213473
- Device name
- Antimicrobial Gelling Fiber Dressing with PHMB
- Applicant
- Advanced Medical Solutions, Ltd. GB
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2023-10-26
- Date received
- 2021-10-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K213473.pdf
Official FDA record: K213473
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.