BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SOUTH53

    Reg #: 3037047821 · FEI: 3037047821 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    SOUTH53
    Registration Number
    3037047821
    FEI Number
    3037047821
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    27131 Calle Arroyo Ste 1722
    City
    San Juan Capistrano
    State
    CA
    ZIP
    92675
    Country
    US

    Regulatory Submissions

    510(k) Number
    K252441

    Owner / Operator

    Firm Name
    South53
    Operator Number
    10094165
    Address
    27131 Calle Arroyo, Ste 1722
    City
    San Juan Capistrano
    State
    CA
    Postal Code
    92675
    Country
    US
    Correspondent
    Rodney Brenneman

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    Primero Safe Access System

    Establishment Types

    Manufacture Medical Device