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

    ELAN-E DISPOSABLE DRAPE

    K Number: K884057 · Decision Oct 19, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    13
    Review Days
    23

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    Basic Information

    Device Name
    ELAN-E DISPOSABLE DRAPE
    K Number
    K884057
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Aesculap Instruments Corp.
    Date Received
    September 26, 1988
    Decision Date
    October 19, 1988
    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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