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510(k) Data Aggregation

    K Number
    K092822
    Device Name
    CAPRI APPLICATOR
    Manufacturer
    VIVARAY, INC.
    Date Cleared
    2009-11-03

    (50 days)

    Product Code
    JAQ
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIVARAY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAPRI™ Applicator is intended for use during brachytherapy procedures. The multiple lumens of the CAPRI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.
    Device Description
    The CAPRI Applicator is a specialized applicator that is temporarily inserted into the vagina or rectum to facilitate the application of radiation to the target site in the treatment of carcinoma. The CAPRI Applicator is provided sterile for single use and is disposable.
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