HT-WEDGE— 510(k) K121287
Substantially EquivalentD.T. Davis Enterprises Ltd. T/A Hovertech Int'L
FDA 510(k) clearance K121287 for HT-WEDGE, Substantially Equivalent on 2012-10-03. Applicant: D.T. Davis Enterprises Ltd. T/A Hovertech Int'L.
Clearance details
- Applicant
- D.T. Davis Enterprises Ltd. T/A Hovertech Int'L
- Product code
- Code FNG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethlehem, PA, US
Adverse events under product code FNG
product code FNG- Death
- 4
- Total
- 4
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.