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

    ENDOMARK STERILE INDIA INK

    K Number: K042901 · Decision Mar 16, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    1
    Applicant Total
    20
    Review Days
    147

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    Basic Information

    Device Name
    ENDOMARK STERILE INDIA INK
    K Number
    K042901
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pmt Corp.
    Date Received
    October 20, 2004
    Decision Date
    March 16, 2005
    Product Code
    NBG
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NBG Marker, Colon

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