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

    BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT

    K Number: K921848 · Decision Oct 1, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    6
    Applicant Total
    10
    Review Days
    167

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    Basic Information

    Device Name
    BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT
    K Number
    K921848
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alm Surgical Equipment, Inc.
    Date Received
    April 17, 1992
    Decision Date
    October 1, 1992
    Product Code
    FSQ
    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
    FSQ Light, Surgical, Instrument

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