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

    BUSSE SURGICAL DRAPE

    K Number: K083424 · Decision Feb 26, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    2
    Review Days
    99

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    Basic Information

    Device Name
    BUSSE SURGICAL DRAPE
    K Number
    K083424
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Busse Hosipital Disposables
    Date Received
    November 19, 2008
    Decision Date
    February 26, 2009
    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 Busse Hosipital Disposables

    K Number Device Name
    K080804 BUSSE PLASTIC LOR SYRINGE