NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit— 510(k) K142956
Substantially EquivalentIntegrated Healing Technologies
FDA 510(k) clearance K142956 for NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit, Substantially Equivalent on 2015-02-24. Applicant: Integrated Healing Technologies.
Clearance details
- Applicant
- Integrated Healing Technologies
- Product code
- Code OMP
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin, TN, US
Adverse events under product code OMP
product code OMP- Death
- 31
- Injury
- 1,707
- Malfunction
- 4,047
- Other
- 1
- Total
- 5,786
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.