K240552
- 510(k) number
- K240552
- Device name
- Irrisept Antimicrobial Wound Lavage
- Applicant
- Irrimax Corporation GA · US
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2024-06-18
- Date received
- 2024-02-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K240552.pdf
Official FDA record: K240552
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.