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    FDA Registration Active 🇺🇸 United States

    8615 - Galenica Vaginal Specula - Small

    Reg #: 1216677 · FEI: 1216677 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COOPERSURGICAL, INC.
    Registration Number
    1216677
    FEI Number
    1216677
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    95 CORPORATE DRIVE
    City
    Trumbull
    State
    CT
    ZIP
    06611
    Country
    US

    Regulatory Submissions

    510(k) Number
    K841909

    Owner / Operator

    Firm Name
    COOPERSURGICAL, INC.
    Operator Number
    9002384
    Address
    95 CORPORATE DR., --
    City
    Trumbull
    State
    CT
    Postal Code
    06611
    Country
    US
    Correspondent
    Mauro Castro

    Products

    Device Name Product Code
    Speculum, Vaginal, Nonmetal HIB

    Proprietary Names

    8615 - Galenica Vaginal Specula - Small 8311 - Galenica Vaginal Specula - Large 8617 - Galenica Vaginal Specula - Large 8616 - Galenica Medium Vaginal Speculum 8309 - Galenica Vaginal Specula - Small 8310 - Galenica Vaginal Specula - Medium 82330 - Sani-Spec® Disposable Specula - Medium 82329 - Sani-Spec® Disposable Specula - Small 82420 - Sani-Scope® Disposable Anoscope 82331 - Sani-Spec® Disposable Specula - Large 82340 - Sani-Spec® Disposable Speculum - Small 82341 - Sani-Spec® Disposable Speculum - Medium

    Establishment Types

    Manufacture Medical Device