K243801
- 510(k) number
- K243801
- Device name
- FRONT-LINE Field Sterilizer (FL135)
- Applicant
- Fort Defiance Industries, LLC TN · US
- Product code
- FLE — Sterilizer, Steam
- Decision date
- 2025-03-07
- Date received
- 2024-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243801.pdf
Official FDA record: K243801
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.