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

    MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES

    K Number: K882208 · Decision Aug 3, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    6
    Review Days
    69

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    Basic Information

    Device Name
    MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES
    K Number
    K882208
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Linde Div. Union Carbide Corp.
    Date Received
    May 26, 1988
    Decision Date
    August 3, 1988
    Product Code
    GEX
    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
    GEX Powered Laser Surgical Instrument

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    Other Clearances by Linde Div. Union Carbide Corp.

    K Number Device Name
    K882209 MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES
    K882210 MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES
    K832143 MARK III OXYGEN WALKER SYS. RESERVOIR
    K823582 OXYGEN CONCENTRATOR UCC-100
    K821841 MEDIGAS SUCTION/DRAINAGE EQUIPMENT