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510(k) Data Aggregation

    K Number
    K992137
    Device Name
    UROLOGICAL CATHETER
    Manufacturer
    APOGEE, INC.
    Date Cleared
    1999-09-03

    (71 days)

    Product Code
    GBM
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    APOGEE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Apogee Medical,Inc. Urinary Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder
    Device Description
    Urinary Catheter
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