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510(k) Data Aggregation

    K Number
    K042901
    Device Name
    ENDOMARK STERILE INDIA INK
    Manufacturer
    PMT CORP.
    Date Cleared
    2005-03-16

    (147 days)

    Product Code
    NBG
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    NBG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endomark™ Sterile India Ink is indicated for endoscopically marking lesions in the GI tract when the endoscopist anticipates the lesion will require surgical removal within thirty days.
    Device Description
    The Endomark™ Sterile India Ink is a sterile, non-pyrogenic ink designed to be used as an endoscopic marker for marking polyps and lesions in the gastrointestinal tract. It is supplied in single-use 10 mL vials.
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    K Number
    K993951
    Device Name
    SPOT ENDOSCOPIC MARKER
    Manufacturer
    CHEK-MED SYSTEMS
    Date Cleared
    2000-02-18

    (88 days)

    Product Code
    NBG
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    NBG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IS INDICATED FOR ENDOSCOPICALLY MARKING LESIONS IN THE GE TRACT MARKING LESTONS IN CONSTITUTIONATES WHEN THE REQUIRE SURGICAL REMOVAL WITHIN (30) THEFTY DAYS .
    Device Description
    Not Found
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