K251860
- 510(k) number
- K251860
- Device name
- Copioumed AAMI 3 Surgical Gown
- Applicant
- Copioumed International, Inc. TW
- Product code
- FYA — Gown, Surgical
- Decision date
- 2026-02-26
- Date received
- 2025-06-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K251860.pdf
Official FDA record: K251860
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.