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510(k) Data Aggregation

    K Number
    K980212
    Device Name
    MITYVAC
    Manufacturer
    PRISM TECHNOLOGIES, INC.
    Date Cleared
    1998-07-09

    (169 days)

    Product Code
    HDB
    Regulation Number
    884.4340
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRISM TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To facilitate delivery of a fetus during vaginal deliver
    Device Description
    Prism's Mityvac and Gesco's Vac-U-Nate consist primarily of the following components: (1) a suction cup and shaft; and (2) handle and valve assemblies. Each device's cup and shaft have a positioning reference printed on them and the shaft has three molded ridges on it. Both devices have the same components. These components are composed of the same materials and processed in the same manner.
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