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

    MASH DERMATOME

    K Number: K861138 · Decision Apr 14, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    11
    Applicant Total
    14
    Review Days
    19

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    Basic Information

    Device Name
    MASH DERMATOME
    K Number
    K861138
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Mecron Medical Products, Inc.
    Date Received
    March 26, 1986
    Decision Date
    April 14, 1986
    Product Code
    GFD
    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
    GFD Dermatome

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