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

    KOMET MEDICAL SURGICAL POWER ACCESORIES

    K Number: K930109 · Decision Aug 25, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    37
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    226

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    Basic Information

    Device Name
    KOMET MEDICAL SURGICAL POWER ACCESORIES
    K Number
    K930109
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.4580
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Brassler USA
    Date Received
    January 11, 1993
    Decision Date
    August 25, 1993
    Product Code
    JDX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JDX Instrument, Surgical, Sonic And Accessory/Attachment

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