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

    INAMED CLOSED-WOUND DRAIN SYSTEM

    K Number: K896491 · Decision Jan 8, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    213
    Same Product Code
    95
    Applicant Total
    7
    Review Days
    56

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    Basic Information

    Device Name
    INAMED CLOSED-WOUND DRAIN SYSTEM
    K Number
    K896491
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Inamed Development Co.
    Date Received
    November 13, 1989
    Decision Date
    January 8, 1990
    Product Code
    GCY
    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
    GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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