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510(k) Data Aggregation

    K Number
    K070836
    Device Name
    EXICLIP EXCS-M
    Manufacturer
    CLEVEX INC.
    Date Cleared
    2007-04-20

    (24 days)

    Product Code
    MJG, FZQ, GDO
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLEVEX INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ExiClip™ EXCS-M is intended to provide a biopsy specimen and/or without biopsy under clinical discretion, remove skin lesions less than 6mm in diameter where simultaneous wound closure is desired.
    Device Description
    The ExiClip™ EXCS-M skin biopsy with wound closure device is a single use, disposable device consisting of a removable skin clip, a blade, and a manual delivery system. The device is to be provided sterile. The skin clip is non-absorbable. The skin clip provides wound closure and must be removed after the wound has healed.
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