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510(k) Data Aggregation

    K Number
    K950943
    Device Name
    ULTRA EASE
    Manufacturer
    LECTEC CORP.
    Date Cleared
    1996-03-07

    (385 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    LECTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Ultra Ease Ultrasound Gel Pad is indicated for use as an ultrasound transmission gel to be used in conjunction with an Ultrasonic Blood Flow Detector to auscultate peripheral vascular perfusion.
    Device Description
    Ultra Ease Ultrasound Gel Pad is a non-irritating, rectangular shaped pad, that consists of a medical grade foam tape ring, a solid hydrogel transmission layer, and a polyester film cover. The pads are individually packaged in heat sealed paper/poly/foil/poly pouches.
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