BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    COMBION SKIN TEST - FOUR PRONG

    K Number: K833999 · Decision Sep 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    24
    Applicant Total
    2
    Review Days
    289

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    Basic Information

    Device Name
    COMBION SKIN TEST - FOUR PRONG
    K Number
    K833999
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Nicholas H. Maganias
    Date Received
    November 21, 1983
    Decision Date
    September 5, 1984
    Product Code
    SCL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SCL Allergen And Vaccine Delivery Needles

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    Other Clearances by Nicholas H. Maganias

    K Number Device Name
    K830688 COMBION SKIN TEST