Tumark for Eviva, Tumark for Brevera— 510(k) K182082
Substantially EquivalentSomatex Medical Technologies GmbH
FDA 510(k) clearance K182082 for Tumark for Eviva, Tumark for Brevera, Substantially Equivalent on 2018-10-31. Applicant: Somatex Medical Technologies GmbH.
Clearance details
- Applicant
- Somatex Medical Technologies GmbH
- Product code
- Code NEU
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Teltow, DE
Adverse events under product code NEU
product code NEU- Injury
- 824
- Total
- 824
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.