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

    COLOSTOMY ENEMA DEVICE

    K Number: K790749 · Decision May 16, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    COLOSTOMY ENEMA DEVICE
    K Number
    K790749
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5895
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Vabar Corp.
    Date Received
    April 17, 1979
    Decision Date
    May 16, 1979
    Product Code
    EXD
    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
    EXD Irrigator, Ostomy

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    Other Clearances by Vabar Corp.

    K Number Device Name
    K790750 COLOSTOMY DEVICE W/ PRESSURE LID