BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS

    K Number: K982313 · Decision Aug 10, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    112
    Registration Numbers
    112
    Same Product Code
    175
    Applicant Total
    6
    Review Days
    40

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    Basic Information

    Device Name
    HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS
    K Number
    K982313
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Weck Closure Systems
    Date Received
    July 1, 1998
    Decision Date
    August 10, 1998
    Product Code
    FZP
    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
    FZP Clip, Implantable

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