K231937
- 510(k) number
- K231937
- Device name
- Foundation Dermal Regeneration Scaffold (DRS) Solo
- Applicant
- Bionova Medical, Inc. TN · US
- Product code
- KGN — Wound Dressing With Animal-Derived Material(S)
- Decision date
- 2023-11-13
- Date received
- 2023-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K231937.pdf
Official FDA record: K231937
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.