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510(k) Data Aggregation

    K Number
    K092829
    Device Name
    INSERTEASE
    Manufacturer
    CHRISTCOT MEDICAL COMPANY
    Date Cleared
    2009-12-02

    (78 days)

    Product Code
    OOW, 876, 884
    Regulation Number
    876.4730
    Why did this record match?
    Product Code :

    OOW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InsertEase™ is to be used as a device for the insertion of prescription and over the counter suppositories into the rectum
    Device Description
    The rectal suppository applicator, to be called, InsertEase™, is a plastic, non sterile, single use device for the insertion of prescription and over the counter suppositories into the rectum. The design of InsertEase™ is substantially equivalent to a vaginal applicator used for inserting vaginal suppositories, creams and tampons. One piece, the plunger, will be movably coupled within a second piece, the barrel. The barrel has an open end to receive and hold a suppository, which is then inserted into the anus. The plunger is then pushed into the barrel and places the suppository within the rectum. InsertEase™ functions in the same way and manner that vaginal applicators insert vaginal suppositories and tampons.
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