K233378
- 510(k) number
- K233378
- Device name
- ABCcolla® Collagen ADM Scaffold
- Applicant
- Acro Biomedical Co., Ltd. TW
- Product code
- KGN — Wound Dressing With Animal-Derived Material(S)
- Decision date
- 2024-10-18
- Date received
- 2023-10-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K233378.pdf
Official FDA record: K233378
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.