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

    CLOSED WOUND DRAINAGE SYSTEMS

    K Number: K874645 · Decision Dec 2, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    213
    Same Product Code
    95
    Applicant Total
    2
    Review Days
    19

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    Basic Information

    Device Name
    CLOSED WOUND DRAINAGE SYSTEMS
    K Number
    K874645
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Hall Laboratories, Inc.
    Date Received
    November 13, 1987
    Decision Date
    December 2, 1987
    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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