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510(k) Data Aggregation

    K Number
    K964580
    Device Name
    CAP-AID (IMPROVED)
    Manufacturer
    NEBEL, INC.
    Date Cleared
    1997-01-10

    (56 days)

    Product Code
    FHA
    Regulation Number
    876.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEBEL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NEBL CAP-AID (Improved) is designed to effectively occlude the male meatus thereby preventing urinary leakage. The product prevents urinary leakage in men with urinary incontinence.
    Device Description
    The CAP-AID (Improved) is exactly similar in indications, design and features to the original CAP-AID device. Only the materials are different. The material changes requested in the "Improved" version allow additional comfort and ease of use for the patient.
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