K243179
- 510(k) number
- K243179
- Device name
- Sterilization Pouch and Roll
- Applicant
- Yichang Xinxin Paper Products Co., Ltd. CN
- Product code
- FRG — Wrap, Sterilization
- Decision date
- 2025-06-26
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243179.pdf
Official FDA record: K243179
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.