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510(k) Data Aggregation

    K Number
    K984211
    Device Name
    MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303
    Manufacturer
    MEDSCAND AB
    Date Cleared
    1998-12-23

    (29 days)

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

    MEDSCAND AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medscand disposable speculum is intended to expose the interior of a vagina for gynecological procedures.
    Device Description
    The Medscand polystyrene speculum is a single-use device to be used by a medical professional to expose the interior of a vagina.
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