K243589
- 510(k) number
- K243589
- Device name
- PAL Sterilization Case
- Applicant
- Microaire Surgical Instruments, LLC VA · US
- Product code
- KCT — Sterilization Wrap Containers, Trays, Cassettes & Ot
- Decision date
- 2025-06-20
- Date received
- 2024-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243589.pdf
Official FDA record: K243589
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.