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

    J TONGS

    K Number: K930021 · Decision Dec 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    19
    Applicant Total
    9
    Review Days
    1065

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    Basic Information

    Device Name
    J TONGS
    K Number
    K930021
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5960
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jerome Medical
    Date Received
    January 5, 1993
    Decision Date
    December 6, 1995
    Product Code
    HAX
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HAX Tong, Skull For Traction

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