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

    SURGICAL BLADES

    K Number: K761322 · Decision Jan 6, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    300
    Registration Numbers
    300
    Same Product Code
    47
    Applicant Total
    33
    Review Days
    10

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    Basic Information

    Device Name
    SURGICAL BLADES
    K Number
    K761322
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Richard-Allan Medical Ind., Inc.
    Date Received
    December 27, 1976
    Decision Date
    January 6, 1977
    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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