K243181
- 510(k) number
- K243181
- Device name
- Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo
- Applicant
- Bionova Medical, Inc. TN · US
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2024-10-31
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K243181.pdf
Official FDA record: K243181
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.