BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER

    K Number: K946243 · Decision Feb 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    21
    Applicant Total
    71
    Review Days
    53

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    Basic Information

    Device Name
    CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER
    K Number
    K946243
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Coloplast A/S
    Date Received
    December 22, 1994
    Decision Date
    February 13, 1995
    Product Code
    EXJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EXJ Device, Incontinence, Urosheath Type, Sterile

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