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

    E-Z PREP(R) TRAY WITH HIBICLENS(R)

    K Number: K935483 · Decision Feb 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    109
    Applicant Total
    632
    Review Days
    86

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    Basic Information

    Device Name
    E-Z PREP(R) TRAY WITH HIBICLENS(R)
    K Number
    K935483
    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
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    November 15, 1993
    Decision Date
    February 9, 1994
    Product Code
    LRO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LRO General Surgery Tray

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