K260725
- 510(k) number
- K260725
- Device name
- BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
- Applicant
- Hindernis DE Mexico, S.A.P.I. DE C.V. MX
- Product code
- FYA — Gown, Surgical
- Decision date
- 2026-05-12
- Date received
- 2026-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K260725.pdf
Official FDA record: K260725
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.