VISULIN TRANSPARENT ADHESIVE DRESSING— 510(k) K894147
Substantially Equivalent for Some IndicationsJames River Corp.
FDA 510(k) clearance K894147 for VISULIN TRANSPARENT ADHESIVE DRESSING, Substantially Equivalent for Some Indications on 1989-08-09. Applicant: James River Corp..
Clearance details
- Applicant
- James River Corp.
- Product code
- Code KGX
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Neenah, WI, US
Adverse events under product code KGX
product code KGX- Injury
- 1,590
- Malfunction
- 1,357
- Other
- 3
- Total
- 2,950
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.