BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇱 Chile

    MADEGOM LTDA. PENROSE DRAIN TUBING

    K Number: K894119 · Decision Aug 18, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    16
    Applicant Total
    2
    Review Days
    67

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    Basic Information

    Device Name
    MADEGOM LTDA. PENROSE DRAIN TUBING
    K Number
    K894119
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Madegom
    Date Received
    June 12, 1989
    Decision Date
    August 18, 1989
    Product Code
    GBW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GBW Catheter, Peritoneal

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