BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF

    K Number: K905574 · Decision Jan 24, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    5
    Applicant Total
    56
    Review Days
    43

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    Basic Information

    Device Name
    SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF
    K Number
    K905574
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    E-Z-Em, Inc.
    Date Received
    December 12, 1990
    Decision Date
    January 24, 1991
    Product Code
    FGD
    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
    FGD Catheter, Retention, Barium Enema With Bag

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