BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    DECA DERMATOME (MICROMOTOR SYSTEM)

    K Number: K945594 · Decision Jun 5, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    203

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    Basic Information

    Device Name
    DECA DERMATOME (MICROMOTOR SYSTEM)
    K Number
    K945594
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Depuy Intl., Ltd.
    Date Received
    November 14, 1994
    Decision Date
    June 5, 1995
    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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