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

    VIVANT MEDICAL BIOPSY MARKER SYSTEM

    K Number: K000278 · Decision Jun 23, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    112
    Registration Numbers
    112
    Same Product Code
    175
    Applicant Total
    10
    Review Days
    144

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    Basic Information

    Device Name
    VIVANT MEDICAL BIOPSY MARKER SYSTEM
    K Number
    K000278
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vivant Medical, Inc.
    Date Received
    January 31, 2000
    Decision Date
    June 23, 2000
    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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