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

    BIOMARC TISSUE MARKER

    K Number: K032347 · Decision Aug 21, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    282
    Applicant Total
    17
    Review Days
    22

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    Basic Information

    Device Name
    BIOMARC TISSUE MARKER
    K Number
    K032347
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4750
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carbon Medical Technologies, Inc.
    Date Received
    July 30, 2003
    Decision Date
    August 21, 2003
    Product Code
    GDW
    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
    GDW Staple, Implantable

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