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

    SURGEON'S GLOVES

    K Number: K811753 · Decision Sep 11, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    206
    Review Days
    81

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    Basic Information

    Device Name
    SURGEON'S GLOVES
    K Number
    K811753
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Travenol Laboratories, S.A.
    Date Received
    June 22, 1981
    Decision Date
    September 11, 1981
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KGO Surgeon'S Gloves

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    Other Clearances by Travenol Laboratories, S.A.

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    K872652 UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
    K870801 FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD
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