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

    FIGLEAF SHIELD

    K Number: K930763 · Decision May 17, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    94

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    Basic Information

    Device Name
    FIGLEAF SHIELD
    K Number
    K930763
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.6500
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Byers Industries, Inc.
    Date Received
    February 12, 1993
    Decision Date
    May 17, 1993
    Product Code
    IWT
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IWT Shield, Gonadal

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IWT), ordered by most recent decision date.

    C.B. RADIOLOGY DESIGN GONADSHIELD

    FDA 510(k)
    FDA Class 1 ·Radiology
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