BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SURGICHIP TAG SURGICAL MARKER

    K Number: K042555 · Decision Nov 9, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    183
    Registration Numbers
    184
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    50

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    Basic Information

    Device Name
    SURGICHIP TAG SURGICAL MARKER
    K Number
    K042555
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4660
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgichip, Inc.
    Date Received
    September 20, 2004
    Decision Date
    November 9, 2004
    Product Code
    FZZ
    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
    FZZ Marker, Skin

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