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

    RADIATION STERILIZED SURGEON'S GLOVES

    K Number: K813565 · Decision Jan 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    206
    Review Days
    31

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    Basic Information

    Device Name
    RADIATION STERILIZED SURGEON'S GLOVES
    K Number
    K813565
    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
    December 22, 1981
    Decision Date
    January 22, 1982
    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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    K872364 HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309
    K872652 UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
    K870801 FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD
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