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510(k) Data Aggregation

    K Number
    K000222
    Device Name
    UM-L25
    Date Cleared
    2000-04-19

    (86 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNION MEDICAL ENGENEERING CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K982860
    Device Name
    UM-L20/ UM-L30
    Date Cleared
    1999-08-13

    (365 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNION MEDICAL ENGENEERING CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UM-L20/UML30 CO2 Laser Units are used in the following applications in order to treat the below mentioned conditions: ENT, Plastic & Reconstruction, Dermatology, Podiatry, Dentalogy, General Practice, Gynecology, Proctology. Specific conditions are listed in tables.
    Device Description
    Not Found
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