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510(k) Data Aggregation

    K Number
    K073182
    Device Name
    GYN DISPOSABLES TENACULUM 356T
    Manufacturer
    GYN-DISPOSABLES, INC.
    Date Cleared
    2007-11-28

    (15 days)

    Product Code
    HDC
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    GYN-DISPOSABLES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Snare, grasp, hold and manipulate cervical and intravaginal tissue.
    Device Description
    GYN Disposables Tenaculum 356T is made of glass reinforced polycarbonate. The GYN Disposable Tenaculum is supplied in a Tyvek pouch and has been sterilized by gamma radiation.
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