Foundation Dermal Regeneration Scaffold (DRS) Solo— 510(k) K231937
Substantially EquivalentBionova Medical, Inc.
FDA 510(k) clearance K231937 for Foundation Dermal Regeneration Scaffold (DRS) Solo, Substantially Equivalent on 2023-11-13. Applicant: Bionova Medical, Inc..
Clearance details
- Applicant
- Bionova Medical, Inc.
- Product code
- Code KGN
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Germantown, TN, US
Adverse events under product code KGN
product code KGN- Other
- 2
- Total
- 2
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.