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

    PRELOADED TISSUE MARKER DEVICE

    K Number: K100994 · Decision Apr 30, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    109
    Applicant Total
    17
    Review Days
    21

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    Basic Information

    Device Name
    PRELOADED TISSUE MARKER DEVICE
    K Number
    K100994
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carbon Medical Technologies, Inc.
    Date Received
    April 9, 2010
    Decision Date
    April 30, 2010
    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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    K130678 BIOMARC GOLD FIDUCIAL MARKER
    K110772 BIOMARC FIDUCIAL MARKER
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