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

    CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM

    K Number: K132463 · Decision Dec 3, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    109
    Applicant Total
    8
    Review Days
    118

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    Basic Information

    Device Name
    CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM
    K Number
    K132463
    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
    Cianna Medical, Inc.
    Date Received
    August 7, 2013
    Decision Date
    December 3, 2013
    Product Code
    NEU
    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
    NEU Marker, Radiographic, Implantable

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