K230529
- 510(k) number
- K230529
- Device name
- HealiAid Dental Collagen Wound Dressing
- Applicant
- Maxigen Biotech, Inc. TW
- Product code
- OLR — Oral Wound Dressing
- Decision date
- 2023-11-22
- Date received
- 2023-02-27
- 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: K230529.pdf
Official FDA record: K230529
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.