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

    BEAVER(R) HANDLE

    K Number: K884512 · Decision Nov 17, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    430
    Registration Numbers
    430
    Same Product Code
    15
    Applicant Total
    632
    Review Days
    21

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    Basic Information

    Device Name
    BEAVER(R) HANDLE
    K Number
    K884512
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    October 27, 1988
    Decision Date
    November 17, 1988
    Product Code
    GDZ
    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
    GDZ Handle, Scalpel

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