BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)— 510(k) K260725
Substantially EquivalentHindernis DE Mexico, S.A.P.I. DE C.V.
FDA 510(k) clearance K260725 for BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10), Substantially Equivalent on 2026-05-12. Applicant: Hindernis DE Mexico, S.A.P.I. DE C.V.. Device class: 2.
Clearance details
- Applicant
- Hindernis DE Mexico, S.A.P.I. DE C.V.
- Product code
- Code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Naucalpan De Juarez, MX
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Data sourced from openFDA. This site is unofficial and independent of the FDA.