scaffolene CL100 Bioresorbable Collagen Matrix— 510(k) K192346
Substantially EquivalentFreudenberg Technology Innovation SE & Co. KG
FDA 510(k) clearance K192346 for scaffolene CL100 Bioresorbable Collagen Matrix, Substantially Equivalent on 2020-02-28. Applicant: Freudenberg Technology Innovation SE & Co. KG.
Clearance details
- Applicant
- Freudenberg Technology Innovation SE & Co. KG
- Product code
- Code KGN
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Weinheim, DE
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.