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

    PERSONNA PLUS SAFETY SCALPEL SYSTEM

    K Number: K032242 · Decision Sep 23, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    300
    Registration Numbers
    300
    Same Product Code
    47
    Applicant Total
    2
    Review Days
    64

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    Basic Information

    Device Name
    PERSONNA PLUS SAFETY SCALPEL SYSTEM
    K Number
    K032242
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omi Manufacturing Pty., Ltd.
    Date Received
    July 21, 2003
    Decision Date
    September 23, 2003
    Product Code
    GES
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    GES Blade, Scalpel

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    Other Clearances by Omi Manufacturing Pty., Ltd.

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