BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    FREE ARM(TM)

    K Number: K884928 · Decision Dec 15, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    162
    Registration Numbers
    162
    Same Product Code
    60
    Applicant Total
    1
    Review Days
    17

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    Basic Information

    Device Name
    FREE ARM(TM)
    K Number
    K884928
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4950
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Faro Medical Technologies, Inc.
    Date Received
    November 28, 1988
    Decision Date
    December 15, 1988
    Product Code
    FWZ
    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
    FWZ Operating Room Accessories Table Tray

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