K230135
- 510(k) number
- K230135
- Device name
- Copioumed Chemotherapy Isolation Gown
- Applicant
- Copioumed International, Inc. TW
- Product code
- FYC — Gown, Isolation, Surgical
- Decision date
- 2023-10-04
- Date received
- 2023-01-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K230135.pdf
Official FDA record: K230135
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.