Exofin Fusion Skin Closure System— 510(k) K191461
Substantially EquivalentChemence Medical, Inc.
FDA 510(k) clearance K191461 for Exofin Fusion Skin Closure System, Substantially Equivalent on 2020-06-05. Applicant: Chemence Medical, Inc..
Clearance details
- Applicant
- Chemence Medical, Inc.
- Product code
- Code OMD
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
Adverse events under product code OMD
product code OMD- Injury
- 1,134
- Total
- 1,134
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.