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

    SURGIMED - SURGICAL BLADES

    K Number: K851157 · Decision Apr 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    300
    Registration Numbers
    300
    Same Product Code
    47
    Applicant Total
    5
    Review Days
    34

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    Basic Information

    Device Name
    SURGIMED - SURGICAL BLADES
    K Number
    K851157
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Surgimed Corp.
    Date Received
    March 22, 1985
    Decision Date
    April 25, 1985
    Product Code
    GES
    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
    GES Blade, Scalpel

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