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510(k) Data Aggregation

    K Number
    K133857
    Device Name
    BRELLA-SPEC(TM) VAGINAL SPECULUM
    Manufacturer
    PROA MEDICAL, INC.
    Date Cleared
    2014-04-28

    (130 days)

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

    PROA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Brella-Spec™ Vaginal Speculum is used for visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations. Brella-Spec™ Vaginal Speculum provides the light necessary to illuminate the field during procedures and examinations.
    Device Description
    The Brella-Spec™ Vaginal Speculum is a sterile, single-use device with built-in LED illumination system to provide optimal visualization and access during gynecological and obstetrical procedures. This speculum was designed to provide visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations. The device is ergonomically designed to maximize the view window using two side blades that are opened by a manually operated ratchet mechanism. The device incorporates a fully enclosed LED illumination system. It is composed of medical grade, biocompatible plastic materials.
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