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    K Number
    K981430
    Device Name
    UNION MEDICAL UM-D30 COAGULATOR
    Manufacturer
    SHE MEDICAL, INC.
    Date Cleared
    1998-06-05

    (46 days)

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

    SHE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UM-D30 Coagulator is used in small surgical procedures in dermatology, plastic surgery and general surgery in order to only coagulate (burn) an open wound or skin lesions. This device does not cut the skin, it only closes open wounds or lesions by coagulating (burning) the skin in any of the small surgical procedures mentioned above.
    Device Description
    Coagulator Device Name: UM-D30
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