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510(k) Data Aggregation

    K Number
    K033205
    Device Name
    MANOA BREAST BIOPSY SYSTEM
    Manufacturer
    MANOA MEDICAL, INC.
    Date Cleared
    2004-02-18

    (139 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MANOA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Manoa Breast Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure. It is for diagnostic purposes only and is not intended for therapeutic use.
    Device Description
    The Manoa Breast Biopsy System is comprised of a sheath introducer, a tissue cutter, a specimen retriever and an electrosurgical cable. The Manoa Breast Biopsy System is a minimally invasive biopsy device designed to penetrate, cut and collect an intact tissue specimen during a biopsy procedure.
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