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

    ILLUMINATED SPECULUM

    K Number: K801058 · Decision May 28, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    0
    Applicant Total
    5
    Review Days
    22

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    Basic Information

    Device Name
    ILLUMINATED SPECULUM
    K Number
    K801058
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.1800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Designs For Vision, Inc.
    Date Received
    May 6, 1980
    Decision Date
    May 28, 1980
    Product Code
    FXF
    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
    FXF Speculum, Illuminated

    Other Clearances by Designs For Vision, Inc.

    K Number Device Name
    K051786 MELIDE FIBEROPTIC LIGHT
    K043530 DVI CURING LIGHT
    K032283 DESIGNS FOR VISION FIBEROPTIC LIGHT
    K013880 DAYLITE XENON LIGHT SOURCES