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    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇹 Italy

    DMS-1000C DERMOABRADER

    K Number: K965256 · Decision Dec 9, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    115

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    Basic Information

    Device Name
    DMS-1000C DERMOABRADER
    K Number
    K965256
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mattioli Engineering, Srl
    Date Received
    August 16, 1996
    Decision Date
    December 9, 1996
    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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