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510(k) Data Aggregation

    K Number
    K982445
    Device Name
    MODULAP
    Manufacturer
    ATC MEDICAL TECHNOLOGY, INC.
    Date Cleared
    1998-09-08

    (55 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATC MEDICAL TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Modulap™ Probe Tips may be used with legally-marketed trumpet valves designed to provide pressurized irrigation solution to the operative site during laparoscopic/endoscopic procedures. The hollow channel present in some of the Modulap™ Probe Tips can also be used to introduce other laparoscopic instruments into the surgical site.
    Device Description
    When used in conjunction with a legally-marketed irrigation pump, irrigant bag or bottle, suction source, and Trumpet Valve, the Candidate Device communicates the Trumpet Valve's suction and irrigation capabilities to the operative site during general laparoscopic surgical procedures.
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