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

    STELLAR SERIES SURGICAL LIGHTS WITH HERMES

    K Number: K021585 · Decision Nov 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    73
    Applicant Total
    19
    Review Days
    183

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    Basic Information

    Device Name
    STELLAR SERIES SURGICAL LIGHTS WITH HERMES
    K Number
    K021585
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Skytron, Div. the Kmw Group, Inc.
    Date Received
    May 14, 2002
    Decision Date
    November 13, 2002
    Product Code
    FSY
    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
    FSY Light, Surgical, Ceiling Mounted

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