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

    FORCEPS, SUTURE, AUTO

    K Number: K772286 · Decision Dec 20, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    8

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    Basic Information

    Device Name
    FORCEPS, SUTURE, AUTO
    K Number
    K772286
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Hartmann Group, Inc.
    Date Received
    December 12, 1977
    Decision Date
    December 20, 1977
    Product Code
    GDO
    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
    GDO Applier, Surgical, Clip

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