MODIFICATION TO SILVER ALGINATE II WOUND DRESSING— 510(k) K063173
Substantially EquivalentAdvanced Medical Solutions Limited
FDA 510(k) clearance K063173 for MODIFICATION TO SILVER ALGINATE II WOUND DRESSING, Substantially Equivalent on 2006-11-03. Applicant: Advanced Medical Solutions Limited.
Clearance details
- Applicant
- Advanced Medical Solutions Limited
- Product code
- Code FRO
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Winsford, Cheshire, GB
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.