Polyver Silver Alginate Dressing (Prescription and OTC)— 510(k) K230190
Substantially EquivalentRoosin Medical Co., Ltd.
FDA 510(k) clearance K230190 for Polyver Silver Alginate Dressing (Prescription and OTC), Substantially Equivalent on 2023-11-17. Applicant: Roosin Medical Co., Ltd..
Clearance details
- Applicant
- Roosin Medical Co., Ltd.
- Product code
- Code FRO
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taizhou, CN
Adverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.