K230190
- 510(k) number
- K230190
- Device name
- Polyver Silver Alginate Dressing (Prescription and OTC)
- Applicant
- Roosin Medical Co., Ltd. CN
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2023-11-17
- Date received
- 2023-01-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K230190.pdf
Official FDA record: K230190
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.