K232758
- 510(k) number
- K232758
- Device name
- Comatryx OTC
- Applicant
- Strukmyer Medical, LLC TX · US
- Product code
- KGN — Wound Dressing With Animal-Derived Material(S)
- Decision date
- 2023-12-01
- Date received
- 2023-09-08
- 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: K232758.pdf
Official FDA record: K232758
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.