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510(k) Data Aggregation

    K Number
    K101373
    Device Name
    EMBRACE
    Manufacturer
    IZI MEDICAL PRODUCTS INC.
    Date Cleared
    2010-09-15

    (121 days)

    Product Code
    IZH
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    IZI MEDICAL PRODUCTS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    emBRACE is intended to provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray technology.
    Device Description
    emBRACE is a radiolucent foam cushion used during radiologic visualization of the breast. emBRACE is non-sterile and is a single use device. emBRACE will be offered in the following configurations for ease of use dependent o the radiological system used: - Product Number 00283-001 for use on an 18x24cm bucky. . - Product Number 00283-100 for use on a 25x29cm bucky. . - Product Number 00283-200 for use on a 29x30cm bucky. .
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