BEUDAMED
    FDA 510(k) Substantially Equivalent for Some Indications 🇺🇸 United States

    DUNN ANTERIOR DISTRACTION SYSTEM

    K Number: K862755 · Decision Jan 22, 1987
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    184

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    Basic Information

    Device Name
    DUNN ANTERIOR DISTRACTION SYSTEM
    K Number
    K862755
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Osteotek, Inc.
    Date Received
    July 22, 1986
    Decision Date
    January 22, 1987
    Advisory Committee
    Unknown
    Review Advisory Committee
    OR
    Third Party
    N