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

    MARKMAN TEMPLATE SYSTEM

    K Number: K970306 · Decision Nov 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    297

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    Basic Information

    Device Name
    MARKMAN TEMPLATE SYSTEM
    K Number
    K970306
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Barry Markman, M.D.
    Date Received
    January 27, 1997
    Decision Date
    November 20, 1997
    Product Code
    GAH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GAH Stylet, Surgical, General & Plastic Surgery

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