K240298
- 510(k) number
- K240298
- Device name
- Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo
- Applicant
- Bionova Medical, Inc. TN · US
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2024-08-21
- Date received
- 2024-02-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240298.pdf
Official FDA record: K240298
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.