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

    H.P. MEDICAL GRADE SILICONE TUBING

    K Number: K780470 · Decision Apr 27, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    18
    Applicant Total
    31
    Review Days
    36

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    Basic Information

    Device Name
    H.P. MEDICAL GRADE SILICONE TUBING
    K Number
    K780470
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5880
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Dow Corning Corp. Healthcare Industries Materials
    Date Received
    March 22, 1978
    Decision Date
    April 27, 1978
    Product Code
    KDL
    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
    KDL Set, Perfusion, Kidney, Disposable

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