BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    STAT PAK

    K Number: K943820 · Decision Nov 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    71
    Applicant Total
    2
    Review Days
    89

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    Basic Information

    Device Name
    STAT PAK
    K Number
    K943820
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Magnum Instruments, Inc.
    Date Received
    August 5, 1994
    Decision Date
    November 2, 1994
    Product Code
    EKJ
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EKJ Burnisher, Operative

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