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

    SILICONE SUCTION & IRRIGATION DRAIN

    K Number: K840323 · Decision Apr 25, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    76
    Applicant Total
    15
    Review Days
    91

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    Basic Information

    Device Name
    SILICONE SUCTION & IRRIGATION DRAIN
    K Number
    K840323
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Superior Plastic Products Corp.
    Date Received
    January 25, 1984
    Decision Date
    April 25, 1984
    Product Code
    GBX
    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
    GBX Catheter, Irrigation

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