K243431
- 510(k) number
- K243431
- Device name
- Medicom Sterilization Pouch and Reel
- Applicant
- Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. TW
- Product code
- FRG — Wrap, Sterilization
- Decision date
- 2025-02-21
- Date received
- 2024-11-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.9 MB · U.S. public domain
Also available from FDA: K243431.pdf
Official FDA record: K243431
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.