K230980
- 510(k) number
- K230980
- Device name
- MicroMatrix® Flex
- Applicant
- Acell, Inc. MD · US
- Product code
- KGN — Wound Dressing With Animal-Derived Material(S)
- Decision date
- 2023-09-22
- Date received
- 2023-04-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K230980.pdf
Official FDA record: K230980
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.