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510(k) Data Aggregation

    K Number
    K042950
    Device Name
    VAG O SPECULUM, MODELS VS1, VM1, VL1
    Manufacturer
    PANATREX, INC.
    Date Cleared
    2004-11-30

    (35 days)

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

    PANATREX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indication for Use: To be used by medical professionals to expose the interior of the vagina to facilitate visualization during gynecological and obstetrical procedures.
    Device Description
    The Vag O Speculum is a non-metal hand-held device used to expose the interior of the vagina.
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    K Number
    K982578
    Device Name
    QUANTI-TEST SYSTEM
    Manufacturer
    PANATREX, INC.
    Date Cleared
    1998-09-02

    (41 days)

    Product Code
    SCLLDH
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    PANATREX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Quanti-Test System is an allergen delivery system which, through a skin prick test, places antigen into the epidermis to indicate a sensitivity to allergens.
    Device Description
    The Quanti-Test System is an allergen delivery system.
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