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

    STERILE SURGICAL DRAPES

    K Number: K830660 · Decision Mar 17, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    6
    Review Days
    15

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    Basic Information

    Device Name
    STERILE SURGICAL DRAPES
    K Number
    K830660
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Phoenix Glove Co.
    Date Received
    March 2, 1983
    Decision Date
    March 17, 1983
    Product Code
    KKX
    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
    KKX Drape, Surgical, Antimicrobial

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    Other Clearances by Phoenix Glove Co.

    K Number Device Name
    K821044 PATIENT PREP KITS/TRAYS-STERILE
    K821666 STERILE SURGICAL DRAPES
    K821043 STERILE PATIENT EXAM. GLOVES
    K801846 ELECTROCARDIOGRAPH ELECTRODE
    K781820 GLOVES, VINYL EXAMINATION