K233151
- 510(k) number
- K233151
- Device name
- PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)
- Applicant
- Medline Industries, LP IL · US
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2024-03-26
- Date received
- 2023-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K233151.pdf
Official FDA record: K233151
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.