K240510
- 510(k) number
- K240510
- Device name
- Microdacyn Hydrogel
- Applicant
- Sonoma Pharmaceuticals, Inc. CA · US
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2024-11-08
- Date received
- 2024-02-22
- 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: K240510.pdf
Official FDA record: K240510
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.