BEUDAMED
    FDA Registration Active 🇫🇷 France

    Polysite

    Reg #: 8020785 · FEI: 3009291251 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    VYGON S A
    Registration Number
    8020785
    FEI Number
    3009291251
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5-11 RUE ADELINE
    City
    ECOUEN 95440 Val-d'Oise
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K122834

    Owner / Operator

    Firm Name
    VYGON S A
    Operator Number
    8020785
    Address
    5-11 RUE ADELINE, --
    City
    ECOUEN
    State
    FR-NOTA
    Postal Code
    95440
    Country
    FR
    Correspondent
    Chris Steinke

    Products

    Device Name Product Code
    Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
    Port Introducer Kit OKE

    Proprietary Names

    Polysite

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device